A Calibration Procedure for W-band On-wafer Testing
calibration verification
Calibration VerificationCalibration verification is a crucial process in various fields, including engineering, science, and manufacturing. It involves the assessment and confirmation of the accuracy and reliability of measuring instruments or equipment. This process ensures that the measurements obtained from these instruments are traceable to a known standard and are within acceptable limits.Importance of Calibration VerificationAccurate measurements are essential for making informed decisions, maintaining quality control, and ensuring safety in many industries. Calibration verification plays a vital role in achieving this accuracy by providing confidence in the measurement results. It helps identify any deviations or errors in the measuring instruments, allowing for appropriate adjustments or corrections to be made.Purpose of Calibration VerificationThe primary purpose of calibration verification is to ensure that measuring instruments are performing within specified tolerances. By comparing the measurements obtained from an instrument with a known reference standard, any discrepancies can be identified. This process provides evidence of the instrument’s accuracy and reliability, allowing for adjustments or recalibrations if necessary.Process of Calibration VerificationThe calibration verification process typically involves several steps: 1.Selection of Reference Standards: The first step is to selectappropriate reference standards that have a higher level ofaccuracy than the instrument being verified. These standardsshould be traceable to internationally recognized standards.2.Establishing Measurement Procedure: A detailed measurementprocedure is established to ensure consistency and repeatabilityduring calibration verification.3.Performing Measurements: The instrument under test is comparedagainst the reference standards using the established measurement procedure. Multiple measurements are taken at different pointsacross the instrument’s range.4.Data Analysis: The collected data is analyzed to determine ifthere are any significant deviations or errors compared to thereference standards.5.Decision Making: Based on the analysis, a decision is maderegarding whether the instrument passes or fails calibrationverification.6.Documentation: All relevant data, observations, and outcomes aredocumented for future reference and audit purposes.Calibration Verification vs. CalibrationAlthough calibration verification and calibration are closely related, they have distinct differences. Calibration involves adjusting or aligning an instrument to match a known standard, whereas calibration verification focuses on confirming the accuracy and reliability of the instrument without making adjustments. Calibration is typically performed by trained professionals, while calibration verification can be carried out by the instrument users themselves.Benefits of Calibration VerificationCalibration verification offers numerous benefits to organizations and industries:1.Quality Assurance: By ensuring accurate measurements, calibrationverification helps maintain product quality and consistency.pliance with Standards: Many industries have specificstandards and regulations that require regular calibrationverification to demonstrate compliance.3.Cost Savings: Regular calibration verification can identifypotential issues early on, reducing the risk of costly errors or failures.4.Increased Efficiency: Accurate measurements lead to improvedefficiency in processes, reducing waste and improving overallproductivity.5.Customer Satisfaction: Reliable measurements instill confidencein customers, leading to increased satisfaction and trust in the organization’s products or services.ConclusionCalibration verification is a critical process that ensures accurate measurements and reliable results in various fields. It providesconfidence in the measuring instruments’ accuracy, allowing forinformed decision-making, quality control, and compliance with standards. By following a systematic approach and using appropriate reference standards, organizations can benefit from improved quality assurance, cost savings, increased efficiency, and enhanced customer satisfaction through calibration verification.。
无损检测工艺规程(磁粉检验)
1. General
1.1 This procedure is applied to the magnetic particle examination of ferromagnetic materials and welds for ASME Code items.
1.2 The magnetic particle examination method is suitable for detecting cracks and other discontinuities on or near the surface in ferromagneticபைடு நூலகம்materials.
1.4 This procedure shall be demonstrated to the satisfaction of the AI prior to implementation.
2. Personnel
2.1 The NDE personnel who engage in magnetic particle examination shall be qualified and certified according to NJBST Co.,Ltd.’s “Written Practice for NDE Personnel Training, Examination, Qualification & Certification”(No.:QCD-011).
医药行业专业英语词汇
医药行业专业英语词汇(非常有用)FDA和EDQM术语: CLINICAL?TRIAL:临床试验? ANIMAL?TRIAL:动物试验? ACCELERATED?APPROVAL:加速批准? STANDARD?DRUG:标准药物? INVESTIGATOR:研究人员;调研人员PREPARING?AND?SUBMITTING:起草和申报? SUBMISSION:申报;递交? BENIFIT (S):受益? RISK(S):受害? DRUG?PRODUCT:药物产品? DRUG?SUBSTANCE:原料药? ESTABLISHED?NAME:确定的名称? GENERIC?NAME:非专利名称? PROPRIETARY?NAME:专有名称;? INN(INTERNATIONAL?NONPROPRIETARY?NAME):国际非专有名称? ADVERSE?EFFECT:副作用? ADVERSE?REACTION:不良反应? PROTOCOL:方案? ARCHIVAL?COPY:存档用副本? REVIEW?COPY:审查用副本? OFFICIAL?COMPENDIUM:法定药典(主要指USP、?NF).? USP (THE?UNITED?STATES?PHARMACOPEIA):美国药典NF(NATIONAL?FORMULARY):(美国)国家处方集? OFFICIAL=PHARMACOPEIAL=?COMPENDIAL:药典的;法定的;官方的? AGENCY:审理部门(指FDA)? IDENTITY:真伪;鉴别;特性? STRENGTH:规格;规格含量(每一剂量单位所含有效成分的量)? LABELED?AMOUNT:标示量? REGULATORY?SPECIFICATION:质量管理规格标准(NDA提供)? REGULATORY?METHODOLOGY:质量管理方法? REGULATORY?METHODS?VALIDATION:管理用分析方法的验证COS/CEP?欧洲药典符合性认证ICH(International?Conference?on?Harmonization?of?Technical?Requirements?for?Registration?of PharmaceuticalsforHumanUse)人用药物注册技术要求国际协调会议ICH文件分为质量、安全性、有效性和综合学科4类。
calibration method
Calibration MethodIntroductionCalibration is a critical process in various fields, including engineering, manufacturing, and scientific research. It refers to the act of adjusting or comparing the measurements of an instrument or system to ensure its accuracy and reliability. Calibration methods are employed to minimize errors and uncertainties in measurements, thereby improving the quality of data obtained.In this article, we will explore the concept of calibration, its importance, and different calibration methods used across industries.Importance of CalibrationAccurate measurements are essential for making informed decisions, ensuring product quality, and maintaining safety standards. Without calibration, measurements can be inaccurate, leading to faulty products, compromised performance, and potential hazards. Calibration helps in:1.Ensuring Accuracy: Calibration ensures that measurements arealigned with known standards, reducing errors and uncertainties.This is crucial in fields such as medicine, aerospace, andmanufacturing, where precision is of utmost importance.2.Maintaining Consistency: Over time, instruments can drift or wearout, affecting their performance. Calibration helps identify andcorrect such issues, ensuring consistent and reliable measurements.plying with Regulations: Many industries have regulatorybodies that require instruments to be calibrated regularly.Compliance with these regulations is essential to meet legalrequirements and maintain industry standards.Common Calibration MethodsVarious calibration methods are employed depending on the instrument or system being calibrated. Let’s explore some of the commonly used calibration methods:1. Direct CalibrationDirect calibration involves comparing the measurements of an instrument to a known standard. This method is suitable for instruments that directly measure physical quantities, such as temperature, pressure, or length. The instrument under calibration is compared to a traceable reference standard, and adjustments are made to align the measurements.2. Interpolation CalibrationInterpolation calibration is used when the instrument being calibrated does not directly measure the desired quantity. It involves creating a calibration curve by measuring known reference points and interpolating the readings obtained by the instrument. This method is commonly used in electrical measurements, where voltage or current is indirectly measured using resistance or capacitance.3. Comparative CalibrationComparative calibration involves comparing the measurements of an instrument under calibration with those of a calibrated reference instrument. Both instruments are subjected to the same input, and any discrepancies in measurements are noted. This method is often used for high-precision instruments, such as oscilloscopes or spectrophotometers.4. Simulation CalibrationSimulation calibration is employed when it is impractical or expensive to create real-world conditions for calibration. In this method, a computer simulation or mathematical model is used to generate test data, which is then compared to the measurements obtained from the instrument. Simulation calibration is commonly used in the calibration of control systems, where replicating real-world scenarios may not be feasible.5. Uncertainty AnalysisUncertainty analysis is an essential part of calibration, particularly when dealing with complex systems or instruments. It involvesquantifying the uncertainties associated with measurements, taking into account factors such as instrument precision, environmental conditions, and human errors. Uncertainty analysis helps establish confidence intervals and provides a more comprehensive understanding of the measurement uncertainties.ConclusionCalibration is a crucial process for ensuring accurate and reliable measurements in various industries. By employing different calibration methods, such as direct calibration, interpolation calibration, comparative calibration, simulation calibration, and uncertainty analysis, measurement errors and uncertainties can be minimized. This, in turn, leads to improved product quality, enhanced safety, and compliance with regulatory standards. Calibration should be performed regularly to maintain the accuracy and reliability of instruments and systems, ultimately contributing to the success of businesses and scientific endeavors.。
FSH作业指导书20-119
分析原理采用双抗夹心法原理,整个过程18分钟完成。
·第1步:40 μl 标本生物素标记抗FSH单克隆抗体和钌(Ru)标记的抗FSH 单克隆抗体混匀混匀。
·第2步:加入链霉亲和素包被的微粒,让上述形成的复合物通过生物素与链霉亲和素间的反应结合到微粒上。
·第3步:反应混和液吸到测量池中,微粒通过磁铁吸附到电极上,未结合的物质被清洗液洗去,电极加电压后产生化学发光,通过光电倍增管进行测定。
通过检测仪的定标曲线得到最后检测结果(定标曲线通过 2 定标点和试剂条形码提供的主曲线成)。
标本要求血清:按标准常规方法采集。
血浆:肝素锂、钠、铵;EDTA-K3 抗凝均可。
如采用柠檬酸盐抗凝的血浆,测定结果较用血清的约低20%,用氟化钠/草酸钾抗凝的约低14%。
标本在2-8度可稳定14天,-20度可稳定6个月。
只能冻融一次。
含沉淀的标本使用前需离心。
不要使用加热灭活的标本。
标本和质控品禁用叠氮钠防腐。
试剂、校准品、质控品和其他所需材料采用罗氏原装配套试剂。
试剂:M:链霉亲和素包被的微粒(透明瓶盖),1瓶,6.5ml。
粒子浓度0.72mg/ml,生物素结合能力: 470ng生物素/mg粒子。
含防腐剂。
R1:生物素化的抗FSH单克隆抗体(灰盖),1瓶,10ml。
浓度2.0mg/l,MES 缓冲液0.05mol/l,pH6.0。
含防腐剂。
R2:Ru(bpy)32+标记的抗FSH单克隆抗体(黑盖),1瓶,10ml,浓度0.8mg/l,MES缓冲液0.05mol/l,pH6.0。
含防腐剂。
其他所需材料:常规实验设备Elecsys E 170/E 411Elecsys 系统清洗液(SysClean),货号11298500Elecsys E 170分析仪所需材料:Elecsys 系统缓冲液(ProCell M),货号12135019Elecsys 检测池洗液(CleanCell M),货号12135027Elecsys PC/CC杯,货号03023141Elecsys 清洗液(ProbeWash M),货号03005712Elecsys 反应杯/加针头/废物袋(CUP/TIP),货号12102137Elecsys 系统清洗适配器(SysClean Adapter M),货号03027651Elecsys E 411分析仪所需材料:Elecsys 系统缓冲液(ProCell),货号11662988Elecsys 测量池清洗液(CleanCell),货号11662970Elecsys 系统清洗液(SysWash),货号11930346Elecsys 适配器(Adapter for SysClean),货号11933159,Elecsys 反应杯(CUP),货号11706829Elecsys 加样头(TIP),货号11706802仪器和校准使用仪器:瑞士罗氏诊断公司生产Elecsys 2010/E 170/E 411全自动电化学发光免疫自动分析仪仪器校准:每批FSH试剂有一条形码标签,含有该批试剂定标所需的特殊信息。
calibration+procedure
Calibration of the Sartorius ME215S2.7.1 Measurement Uncertainty and Minimum Weight1. The measurement uncertainty of a balance, used for "accurately weighing", mustbe determined. In the case of a new balance, this shall be done at the OQ stage.For all balances, the measurement uncertainty and minimum weight shall bedetermined at the 6 monthly planned maintenance and at anytime the balance isrelocated. If it is necessary to determine minimum weight between PM visits, thefollowing procedure should be followed.2. Use a 100mg weight for replicate weighings. Perform 10 replicate weighings.3. Calculate standard deviation (sd) of the 10 replicate weighings, using the following formula:sd4. Measurement Uncertainty is calculated as being three times the standard deviationof ten replicate weighings divided by the mean of the ten readings for that weight(√10).The minimum uncertainty (MU) is calculated as follows:MU = (3 x sd)/Mean weightHence the minimum weight can be calculated as follows:Minimum weight = Calculated MU x Mean weight x 1000Record results in Appendix V. Results must be second person reviewed for errors,and signed.2.7.2 Weekly Full Calibration of 5 Place Analytical Balances1. Check the balance is level, then zero the balance by suitable means and performan internal calibration, adjustment. To do the Internal Adjustment process, pressthe ‘CAL’ softkey, then press the ‘Start’ softkey.2. Using mass pieces of nominal weight values 100mg, 1g, 10g and 200g, performthe following procedure:3. Place the weight on the pan, allow to stabilise and record the value on the balanceweight record sheet (Appendix II). The weight should be within the followingranges :-Weight Tolerance from Certified Value100mg ± 0.1%1g ± 0.05%10g ± 0.01%200g ± 0.0005%TABLE 1USP<1241> states that minimum uncertainty should be no more than 0.1% of the mass weighed. Since the ME215S balance specification fits well within this range for mass pieces over 1g, the limits have been tightened to check functional operation of the balance.4. If any of the calibration data falls outside these limits, a repeat determinationshould be performed. Failure should be reported to the QC manager, calibrationco-ordinator or raw material team leader.2.7.3 Daily Drift Check1. Measure the drift on a daily basis (except weekends and laboratory shutdowns)using a single, individual check-weight which will be used on the same balance.The mass of the check-weight is determined by the mean of 10 replicateweighings of the 20g nominal weight ± 0.2mg which is performed every sixmonths. Tare the balance before each of the 10 readings, which must be within0.2mg of the final mean. This tolerance needs to be established anytime the checkweight is changed or the balance undergoes maintenance, repair or is moved. UseAppendix IV to record check weight determination. A second person must reviewfor errors and sign each time a determination is done.2. The observed variation in the weight must not exceed ±0.2mg of the checkweight, above. Record daily check weight in relevant Appendices (5 placebalance, Appendix III)3. If a balance fails the daily drift check an ‘out of use’ label must be filled in andattached to the instrument and arrangements should be made to have the balancechecked by an engineer.。
率定曲线的英文
率定曲线的英文1. 定义与释义- 单词:率定曲线(calibration curve)- 1.1 词性:名词- 1.2 释义:用于确定两个变量之间关系的曲线,通常在测量或实验中使用。
- 1.3 英文解释:A curve used to determine the relationship between two variables, usually used in measurement or experiment.- 1.4 相关词汇:标准曲线(standard curve)、拟合曲线(fitted curve)2. 起源与背景- 2.1 词源:率定曲线这个术语主要在科学和工程领域中使用,其起源可能与测量和校准的需求有关。
- 2.2 趣闻:在实验室中,科学家们常常花费大量时间来绘制和验证率定曲线,以确保测量结果的准确性。
有时候,一个小小的误差可能会导致整个实验结果的偏差,所以率定曲线的绘制需要非常谨慎。
3. 常用搭配与短语- 3.1 绘制率定曲线(draw a calibration curve)- 搭配解释:通过实验数据绘制出用于确定两个变量之间关系的曲线。
- 例句:We need to draw a calibration curve to determine the relationship between the concentration and the absorbance.- 中文翻译:我们需要绘制一条率定曲线来确定浓度和吸光度之间的关系。
- 3.2 率定曲线方程(calibration curve equation)- 搭配解释:描述率定曲线的数学方程。
- 例句:The calibration curve equation can be used to calculate the unknown concentration.- 中文翻译:率定曲线方程可以用来计算未知浓度。
- 3.3 验证率定曲线(verify a calibration curve)- 搭配解释:检查率定曲线的准确性和可靠性。
Clibration & Preventative Maintenance
Calibration & Preventative MaintenanceSally Wolfgang Manager, Quality Operations Merck & Co., Inc.Calibration & Preventative MaintenanceCalibration: A comparison of two instruments or measuring devices one of which is a standard of known accuracy (traceable to national standards) to detect, correlate, report or eliminate by adjustment, any discrepancy in accuracy of the instrument measuring device being compared to the standard.Calibration & Preventative MaintenanceCalibration Programs Required by Regulatory Authorities• “Automatic, mechanical, or electronic equipment or other types of equipment, including computers, or related systems that will perform a function satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such equipment is so used, it shall be routinely calibrated, inspected, or checked according to a written program designed to assure proper performance. Written records of those calibration checks and inspections shall be maintained.” US Code of Federal Regulations, 21 CFR 211.68, 1/20/95 • Maintenance at appropriate intervals to prevent malfunction & shall be “preventative” not “reactive” maintenance. US Code of Federal Regulations, 21 CFR 211.67Calibration & Preventative MaintenanceCalibration Programs Required by Regulatory Authorities• Calibration requirements for Laboratory Instruments US Code of Federal Regulations, 21 CFR 211.67 –Specific Directions –Schedules –Limits of accuracy & precision –Remedial Actions –Systems to prevent usage of instruments failing calibration • “Control, weighing, measuring, monitoring and test equipment that is critical for assuring the quality of intermediates or APIs should be calibrated according to written procedures and an established schedule.” ICH Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients, 10 November 2000.Calibration & Preventative MaintenanceEach Manufacturing Area:• • • • • •Written calibration procedures that use traceable calibration standards or calibration equipment. Preventive maintenance procedures and / or referenced manuals Qualified individuals (having the appropriate education, training, background and experience) responsible for calibrating & maintaining instrumentation Second person check of all calibration and maintenance Qualified individuals responsible for monitoring the calibration and maintenance program. Ensure the calibration program and procedures are reviewed and approved by QualityCalibration & Preventative MaintenanceInstrument / Equipment Master List• • • •System for identification of all GMP related instrumentation in a manufacturing area or laboratory Include instrumentation details (serial number, model number & location) If automation components are tracked separately through the configuration management then it is not necessary to include (must verify) Procedures must exist that identify the calibration and maintenance requirements for each instrumentation / equipment on the master listRetired Equipment:–Records pertaining to retired / obsolete equipment must be kept according to company’s records retention procedures –Records should include date the unit was retired, person responsible and the reason for retirement / discardCalibration & Preventative MaintenanceInstrument Identification & Calibration Status• Each instrument given a unique identifier • Instrumentation details associated with this number must be documented and available (e.g. serial number, model number, location, etc.) • Each instrument should be labeled with the unique identifier • Calibration status of each instrument , the date of calibration, the next calibration date and the identification of person performing calibration should be readily available • Appropriate systems to document calibration status include calibration logs, MAXIMO, and calibration stickersCalibration & Preventative MaintenanceInstrument Identification & Calibration Status• System must be in place to prevent use of an instrument that is not qualified, unusable due to damage or malfunction, or has exceeded its established calibration interval • System must be in place that identifies instruments that do not require calibration to be performed beyond the original or factory calibration to distinguish from those instruments that do require scheduled calibrations ⇒Documentation required for excluding equipmentCalibration & Preventative MaintenanceTraceability of Standards / Calibration Equipment• Calibration reference standards / calibration equipment shall be traceable to national standards and be accompanied by certificates of traceability / analysis • If recognized standards are not available, an independent reproducible standard may be used • The calibration tolerance of a given standard should be as tight or tighter than the tolerance of the instrument to be calibrated • A procedure must be in place to ensure tracking and monitoring of standard’s expiration date and re-calibration / re-certification requirements • Re-calibration records must be retainedCalibration & Preventative MaintenanceInstrument Calibration Tolerances•Instrument calibration tolerance limits should be established so problems are identified and corrected in a timely manner •When assigning tolerances, considerations given to: – Capability of the instrument being calibrated (what the manufacturer claims the instrument can achieve). – Parameters at which the instrument operates (ex: if testing accuracy of + 0.5% is required, the instrument calibration tolerances should be <0.5%) – Work environment - environmental conditions can affect the performance of the instrumentationCalibration & Preventative MaintenanceInstrument Calibration Tolerances•Practice of using “Alert” & “Action” levels •“Alert” Tolerance (“Adjustment Limit”) –Related to instrument performance –Level at which the instrument is adjusted back into range –Not required - an industry “best practice”Calibration & Preventative MaintenanceInstrument Calibration Tolerances•“Action” Tolerance (“Calibration Limit” or “Out-of-Tolerance”) –Tied to process performance –Level at which the potential for product impact exists –Possible atypical investigation or reporting is required •Deviations beyond “Alert” level but not at “Action” level would not require investigation - May require adjustment, changes to PMs •Setting of “Alert” and “Action” levels should be described in SOPs, be defendable and have Quality review and approvalCalibration & Preventative MaintenanceCalibration and Maintenance Frequencies•May be determined for individual instruments or groups of instruments (similarity of construction, reliability, and stability) •Considerations when determining calibration frequency: –Accuracy of the measurement / instrument range –Consequences of incorrect value caused by out of calibration –Extent & criticality of use of the instrument & tendency to wear and drift –The manufacturer’s recommendations –Environmental & physical conditions (temperature, humidity, vibration) –Previous calibration records, history of calibration problems & repair history –Frequency of calibration checks prior to use or in-between intervals –Redundant / back-up systems (provides secondary source of information available from other calibrated primary instruments) –Results of Qualification studies –Process requirements –Availability of built-in / automatic calibration checksCalibration & Preventative MaintenanceCalibration and Maintenance Frequencies• Changes to frequency must be approved per change control SOPs • References to specific instrument procedures listed in compendia (USP, BP or EP) for calibration tests for specific laboratory instruments • Calibration time “windows” should be established around calibration due datesCalibration & Preventative MaintenanceCalibration and Maintenance Frequencies• Policy for Calibration and Maintenance Intervals & Schedules Include: ⇒Extending Intervals ⇒Reducing Intervals ⇒Maximum IntervalsCalibration & Preventative MaintenanceMaintenance Requirements• Manufacturer’s recommendations • Parts that wear: gaskets, seals & bearings • Parts requiring periodic replacement: filters, belts & fluids • Parts requiring periodic inspection and cleaning • Parts requiring periodic adjustments, tightening and lubricationCalibration & Preventative MaintenanceCalibration and Maintenance Procedures• Shall include specific directions and limits for accuracy & precision • Shall include guidance for remedial action when accuracy & precision limits are not met • Normally provided in the manufacturer’s manuals • Some compendial requirements exist for some specific laboratory instrumentation • Performance checks (e.g. system suitability, daily balance performance checks) are NOT suitable substitutes for regularly scheduled calibrationsCalibration & Preventative MaintenanceCalibration and Maintenance ProceduresEach calibration & maintenance procedure should include the following:–Identification of department responsible to perform the calibration or maintenance –Step-by-step calibration instructions, reference to appropriate calibration procedures or instrument manuals –Methods for preventive maintenance or reference to appropriate instrumentation manuals –Calibration equipment used in the calibration (e.g. spectroscopy filters, voltmeters, digital thermometers, etc) –Calibration parameter and tolerance ( + )Calibration & Preventative MaintenanceCalibration and Maintenance ProceduresEach calibration & maintenance procedure should include the following:–Required environmental controls or conditions, where appropriate –Provisions for adjustments, if needed –Requirement for recording actual measurements before (“as found”) and after adjustment or preventive maintenance (“as left”) Note: “as found” recordings are not required where routine performance checks are available to provide evidence indicating instrument is operating properly and is suitable for use (e.g. HPLC system suitability, manual balance checks which encompass range of use, etc.)Calibration & Preventative MaintenanceCalibration and Maintenance Procedures–Actions to be taken if instrumentation cannot be calibrated (e.g. contact appropriate service people, label and remove from service) –A step to record all calibration & maintenance activities.Calibration & Preventative MaintenanceUse of Contractors / Vendor Service Personnel– Must have a procedure for approving contractor activities – Contractors must have appropriate training / qualification – Responsible to review & approve the contractors calibration and maintenance procedures. – Responsible to perform actions or steps not part of the contractors procedures.Calibration & Preventative MaintenanceCalibration & Maintenance Records– All calibration records must be retained per document retention procedures – Should include “as found” measurements, results of adjustments (“as left”) and appropriate review & approval of all results – Tolerance or limit for each calibration point – Identification of standard or test instrument used – Identification of persons performing the work and checking the results with datesCalibration & Preventative MaintenanceCalibration & Maintenance Records– Review must ensure the approved activities have been completed and all results have passed the established acceptance criteria – Periodic review of historic calibration & maintenance data to evaluate appropriateness of established frequenciesCalibration & Preventative MaintenanceProcedures for Out-Of-Tolerance Calibration ResultsActions required when critical instrument found outside of established instrument calibration limits (“Action Limit”,Out-Of-Tolerance, OOT): Critical Instrumentation: Any instrument employed in the production of bulk pharmaceutical chemicals, drug or biologics product that controls and/or is used to measure a parameter that affects the validation state of the product (Critical Process Parameters) and any other quality parameter designated as such. Also includes laboratory instrumentation used to measure conformance to component and/or product specifications.Calibration & Preventative MaintenanceProcedures for Out-Of-Tolerance Calibration ResultsInstrument Mechanic: • Immediate review of calibration data to verify validity of OOT • Notification to supervisor or responsible personCalibration & Preventative MaintenanceProcedures for Out-Of-Tolerance Calibration ResultsInstrument Services: • Corrective Action to the instrument ASAP (repair, re-calibration, replacement or removal from service) • Investigation and documentation into root cause of OOT ⇒Historical review of instrument performance & factors relevant to setting calibration frequency ⇒Corrective Actions to prevent recurrence ⇒Re-calibration after maintenance or repair • OOT Notification issued to instrument owner (after results validated) • OOT Notification should include current calibration data, magnitude of OOT error, and date of last successful calibrationCalibration & Preventative MaintenanceProcedures for Out-Of-Tolerance Calibration ResultsInstrument Owner: • Evaluate impact of OOT on product quality. • Impact evaluation based on SOP which is approved by Quality and defines how / when Quality will be notified. • Ex. of OOT with impact on quality: ⇒Instruments used in acceptance / rejection of materials and product ⇒Control / monitoring of critical process parameters ⇒Process controls affecting the final product quality or yield ⇒Instruments required by regulation (e.g. Magnahelic gauges, RH monitors, etc.) ⇒Calibration reference standardsCalibration & Preventative MaintenanceProcedures for Out-Of-Tolerance Calibration ResultsInstrument Owner: • Needs complete understanding of the process requirements for the parameter measured by the OOT instrument • Evaluate magnitude of error in the “As Found” OOT vs. process requirements to determine quality impact • Ex. of OOT with no impact on quality: ⇒A temperature transmitter is reading 0.2oC low and is OOT for that instrument. There is no potential for quality impact if: - Process requires temperature reading accuracy of +/- 1oC - Measures a range / CPP with max. 85oC and process normally runs at 75oC.Calibration & Preventative MaintenanceProcedures for Out-Of-Tolerance Calibration Results• Decisions regarding impact on quality must be documented, approved by Quality and documentation retained • OOT events should be tracked and trended to identify problem instruments • Historical information on OOT events should be readily retrievableCalibration & Preventative MaintenanceChange Control Management• Changes to calibration tolerances, frequency, procedures, addition to / deletion from calibration program, changes in location and different replacement parts should be documented in a change control program • May also require re-calibration, re-execution / revision of instrument’s Installation Qualification (IQ), Operational Qualification (OQ) or Performance Qualification (PQ) • Update of qualification records: drawings, parts list, etc. • Appropriate review and approval by responsible departments and QualityCalibration & Preventative MaintenanceFDA 483Calibration LimitsManufacturing processes are not adequately controlled. For example the blender used was shown by calibration records to be in error by nearly one minute for a process that is specified by validation reports to be exactly four minutes. The 25% error in blender agitation timing has not been evaluated as to any effect on drug product quality.Calibration & Preventative MaintenanceFDA 483CalibrationCalibration of scales is scheduled twice a year, however, there is no provision to verify their accuracy with weights between calibrations.Calibration & Preventative MaintenanceFDA 483CalibrationScale Calibration Records did not include: • Percent variance between test readings and actual NIST weight • Reproducibility studies and standard deviation calculations • Accuracy of the scale regarding the number of decimal points • Accuracy of the scale regarding the minimum / maximum weightsCalibration & Preventative MaintenanceOut of Tolerance (OOT) for Critical EquipmentSuggested OOT FlowchartInstrument Mechanic: Verifies Calibration ResultIs Calibration Result Valid?NoInvalidate, Document & RecalibrateYesInstrument Services Group: Repairs & Recalibrates, Replaces, or takes out of service Investigates Root Cause Plans & Documents Corrective ActionInstrument Services Group: Issues Out of Tolerance Notification Instrument Owner: Evaluates Potential Impact on Product QualityComplete OOT report & file in MaintenanceNoIs there potential for impact on product quality?YesAre Quality-approved procedures in place that define the criteria for potential quality impact?Yes Notifies Quality Initiates Atypical Investigation Assess Impact on Product Quality YesPlan & Document Corrective Action, Document & Retain Atypical Investigation Determine Disposition of ProductNoYesIs Quality Impacted??NoDocument & Retain Atypical Investigation。
美国GMP指南(英文)
GUIDELINE FORGOOD MANUFACTURING PRACTICESINSPECTIONSPAN AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION WORKING GROUP ON GOOD MANUFACTURING PRACTICESMEMBERS*Justina Molzon*, Associate Director for International Programs, FDA/USA. Group CoordinatorArgentina: Carlos Chiale; Rodolfo Mocchetto*, Coordinator INAME/ANMATBrazil: Antonio Bezerra, Suzana Avila*, Inspección y Control de Medicamentos, ANVISACanada: France Dasereau, Stephen McCaul; Louise Jodoin*, Inspection Unit, Health CanadaChile: Magadalena Reyes*, Inspector GMP. Instituto de Salud Pública (ISP) Guatemala: Esmeralda Villagran; José Luis Aguilar; Norma de Pinto*, Jefe Monitoreo y Vigilancia de Medicamentos, Ministerio de SaludMexico: Rosa María Morales, Suleta García*, COFEPRISVenezuela: Elsa Castejón*, Asesora Dirección de Drogas y Cosméticos, Ministerio de Salud.ALIFAR: Miguel Maito, Gerente Laboratorios Farmacéuticos Argentina; Marisela Benaim*, CIFAR, VenezuelaFIFARMA, Marco Vega, QA/QC Manager, Lilly; Carmen Araujo, Laboratorios Elmor, Marisela Poot,* GSK Regulatory DirectorResource Persons:Rebecca Rodríguez, National Expert Drugs Investigator. FDA/USAMillie Barber, International Programa Manger, FDA/USASecretariatRosario D’Alessio, PAHO/WHOJuana M. De Rodriguez, PAHO-GuatemalaMiguel A. Lopez, PAHO-Venezuela*Current membersINTRODUCTIONThis Guideline for Good Manufacturing Practices Inspection for the pharmaceuticalindustry was prepared by the Working Group on Good Manufacturing Practices (WG/GMP), inMay 2003. The Guideline addresses the requirements of the WHO Technical Report onGood Manufacturing Practices # 32 and the particular considerations of all members of thegroup.The WG/GMP proposed a plan for Guideline validation, to the Steering Committee of thePan-American Network for Drug Regulatory Harmonization, which was approved and was developed in two parts:1. The Guideline was implementation in a pilot phase at volunteering pharmaceuticalindustry plants. PAHO/WHO Consultants, Drug Regulatory Officers and people from thepharmaceutical industry conducted the pilot implementation at several plants in differentcountries of the Americas Region. The guideline was later revised according to theircomments and suggestions regarding the contents and usefulness.2. The Guideline was published in the PAHO/WHO web page to promote participation anddiscussion by institutions and professional experts in this topic. This gave all those whowere interested, the opportunity to send suggestions, comments, or to simply give theiropinion. The Guideline remained in the web page since June 2004 in order to receivecomments and others input.Associations like (ALIFAR and FIFARMA) and countries (Argentina, Guatemala andVenezuela) also sent their comments.The GMP Working Group reviewed and analyzed all the comments received and preparedthis revised version of the Regional Guideline of GMP Inspection for the Americas, which is submitted for consideration to the IV Pan American Conference on Drug Regulatory Harmonization.Some of the advantages of the Guideline are:1. The guideline will help to establish the standards for GMP inspections;2. It will be more comprehensive than what is in place in the economic blocks (countries)and will send the message that countries need to work as a community to meetestablished standards; and therefore, improve the quality of pharmaceutical products;3. It will serve as a work model necessary for common criteria;4. It should not be used as a check list, but it should show principles important toconsider in association with an inspection;5. It can be used as a training document for GMP inspections; and6. It will be helpful to countries in educating inspectors with unified criteria.TABLE OF CONTENTSCHAPTER 1 (5)ADMINISTRATION AND GENERAL INFORMATION (5)CHAPTER 2 (8)PERSONNEL (8)CHAPTER 3 (10)PREMISES (10)GENERAL CONDITIONS (10)ANCILLARY AREAS (11)MAINTENANCE (12)CHAPTER 4 (13)WATER SYSTEMS (13)POTABLE WATER (13)PURIFIED WATER (14)WATER FOR INJECTION (17)CHAPTER 5 (21)STORAGE AREAS (21)CHAPTER 6 (29)RETURNED PRODUCTS (29)CHAPTER 7 (30)PRODUCTS RECALL (30)CHAPTER 8 (31)DOCUMENTATION (31)CHAPTER 9 (40)SAMPLING AREA (40)CHAPTER 10 (41)WEIGHING AREA (41)WEIGHING AREA (42)WEIGHING AREA (43)CHAPTER 11 (44)PRODUCTION (44)NON-STERILE PRODUCTS (44)PRODUCTION (53)SEGREGATED PHARMACEUTICAL PRODUCTS (53)PRODUCTION (54)STERILE PRODUCTS (54)CHAPTER 12 (68)QUALITY CONTROL (68)CHAPTER 13 (78)QUALITY ASSURANCE (78)CHAPTER 14 (83)VALIDATION (83)CHAPTER 1REF:ADMINISTRATION AND GENERAL INFORMATIONWHO 321 What is the company's name?________________________________________________________________________2 What is the company's legal address?_______________________________________________________________________3 What is the manufacturing site’s address?______________________________________________________________________4 Does the company have authorization, according to the regulations of each country, at other address(es)(warehouses, quality control laboratory, etc.) which are under the company’s responsibility?If "YES", indicate which companies and provide their addresses._______________________________________________________________________________________________________________________________________________________________________________________________________________5 Is there evidence of registration of the qualified person responsible by the Regulatory Authority?____________________________________________________________________________________________________________________________________________6 Is the qualified person responsible, according to company's organization chart, present at the time of theinspection?YESPROVIDE INFORMATION REGARDING THIS PERSON (WHO RECEIVES THE INSPECTION)________________________________________________________________________________________________________________________________________NO7 Is there evidence of a license to operate issued by the Regulatory Authority?Indicate all authorized activities.______________________________________________________________________________________________________________________________________REF:ADMINISTRATION AND GENERAL INFORMATIONWHO 328 Does the company develop exclusively those production and quality control activities properly authorizedby the Regulatory Authority?YESNO9 Does the company manufacture dietary supplements?YESNO10 Does the company manufacture cosmetic products?YESNO11 Does the company manufacture veterinary products?YESNO12 Does the company manufacture reagents for “in vitro” diagnostic use?YESNO13 Does the company manufacture reagents for “in vivo” diagnostic use?YESNO14 Does the company manufacture other products not indicated above?YESIf “YES” indicate below__________________________________________________________________________________________________________________________________NO15 Does the company manufacture products with beta-lactam active ingredients (penicillins /cephalosporins)?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO16 Does the company manufacture products with cytostatic / cytotoxic active ingredients?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO17 Does the company manufacture products with hormone active ingredients?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NOREF:WHO 32ADMINISTRATION AND GENERAL INFORMATION17.1 Does the company manufacture products with corticosteroids active ingredients?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO18 Does the company manufacture products with active ingredients from biological origin?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO19 Does the company manufacture products with active ingredients from biotechnological origin?YESIf "YES", indicate in which pharmaceutical dosage form__________________________________________________________________________________________________________________________________NO20 Is there a list available of current licensed products? Attach the listYESNO21 Is there a list available of marketed products? Attach the listYESNO21.1 Do all marketed products and its pharmaceutical presentations have current (valid) license?YESNO22 Are the updated building schematics approved by the Regulatory Authority shown, if required?YESNO23 Section 8. Does the company have contract production activities? YESNO24Section 8 Is there documentation certifying registration/authorization of the third party contracted by the Regulatory Authority?YESNO25 Section 8.15 Is there batch documentation issued by the third party in charge of production? YESNO26 Section 8 Does the company act as a third party producer? YESNO27 Sections 8.1, 8.3, 8.12 and8.13 If the company produces by or for third parties, are there contracts that link the parties? YESNOCHAPTER 2PERSONNELREF:WHO 32YES NO1 Sections 10.1, 10.4, 10.11,10.23. Are there Standard Operating Procedures (SOP) related to personnel, including professional qualification, training?2Section 10.3.Is there an updated organization chart of the company? Attach copy3 Section 10.3 Is there a description of the responsibilities and functions of production and quality control personnel?4 Section 10.6. Are the responsibilities of production and quality control personnel independent of each other?5 Section 10.7. Are there trained personnel for the supervision of production and quality control activities?6 Section 10.12. Is there a program for training new employees on GMP, including specific training appropriate to the duties assigned to them?6.1 Section 10.4,10.12. Is there a program for continuous training on GMP for all staff, including specific training appropriate to the duties assigned to them?6.2Section 10.12Are records kept?7 Section 10.15,10.23 Is there a SOP dealing with the use of proper clothing for other persons who enter production areas (technical service/maintenance, cleaning personnel, quality control inspectors, quality assurance inspectors, and visitors)?8 Section 10.23 Are there visible written instructions and/or diagrams for the right use of clothing in the change rooms and other areas where they are required?9 Section 10.16 Are the personnel required to undergo a medical examination prior to being employed (including sensitivity test to beta-lactam substances, if required)?10Section 10.1Are the personnel subject to periodic medical examinations, at least once a year?10.1Sections 10.18,10.19.Are the personnel required to report health problems?11 Section 10.16,10.18 Is there a procedure to prevent any person who has an apparent illness from entering areas in which they may adversely affect the quality of the product or affect their own health?12 Section 10.22 Is smoking, eating, drinking and chewing prohibited in production, storage and laboratory areas?REF:WHO 32PERSONNEL YES NO13Section 10.17Are the personnel instructed to wash their hands before entering production areas?13.1 Section 10.17 Are there signs posted outlining mandatory hand washing before exiting, in change rooms and washrooms?14Section 10.21.Are the personnel using the appropriate uniform for the specified area?12.1Section 11.12.Are the uniforms clean and in good condition?CHAPTER 3PREMISESGENERAL CONDITIONSREF:WHO 32YES NO1Section11.1Is the building exterior in good conditions?2 Section 11.2. Are there any sources of environmental contamination in the area surrounding the building?2.1Section11.2.If "YES", are protective measures undertaken?3 Section 11.2. Are the free and non-productive areas belonging to the company in good clean and orderly conditions?4 Section 11.2. Are the roads leading to the building tarred and/or built so that dust from the road is not a source of contamination inside the plant?5 Section 11.6 Is there any protection against the entry of rodents, insects, birds and other animals?6Section14.46(f)Is there a written pest control program with its respective records?7Section14.46(f)Is there a SOP for pest control?7.1 Does the SOP indicate the substances used for pest control?7.2 Does the Regulatory Authority authorize the used substances?8 Section 4.1 Does the SOP ensure the avoidance of contamination of starting materials, packaging materials, in process-products and finished products with rodenticides and/or fumigant agents?9 Sections 11.1;11.2and 11.21 Is the flow of personnel and materials such that they prevent product contamination?10 Are corridors free of in-transit materials?11 Sections 11.5 and 11.26 Are air conditioning and/or ventilation systems for each area in accordance with the operation to be carried out?WHO 32GENERAL CONDITIONSYES NO12Section11.5.Are visible electric installations in good conditions?13 Section 12.4. Are water, gases, electricity, steam, compressed air and other gas pipelines identified?14 Does the company comply with the national legislation on fire control andprevention?15 Sections 13.38 13.39 Are there SOPs for waste classification and treatment? Are they followed (or complied with)?16Sections13.38 and13.39Is waste treatment undertaken in the premises?16.1 Sections 13.38 and 13.39 If "YES", is there a specific area for waste treatment, completely separated from manufacturing areas?REF:WHO 32 ANCILLARY AREAS YES NO 1Section11.8.Are there general change rooms in the plant?2 Section 11.8. Are toilets, change rooms and showers separated from manufacturing areas?Are they of easy access, and in good condition with respect to cleanliness, sanitation, order and conservation?Are they adequate for the number of users?3 Section 11.7 Are the dining room, social areas and cafeteria (rest and snacks) separated from production areas?4 Sections 10.21 and 10.23. Are plant staffs (temporary and permanent) provided with proper working clothes for each area, including protective coverings to avoid direct contact with products and to protect themselves?5 Are there SOP’s for washing uniforms separately depending on the type of area(sterile, non sterile, maintenance, special products)?6 Is there a laundry area for uniforms which is separate from production areas?7 If an outside laundry facility is used, are personnel and the person responsibleinstructed about the corresponding SOP?7.1 Are there instruction records?WHO 32 ANCILLARY AREAS YES NO7.2 Is this outside laundry facility periodically audited?7.3 Are there audit records?REF:WHO 32 MAINTENANCE YES NO 8Section11.9.Are the maintenance areas physically separated from production areas?9 Is there a SOP of the use, cleaning and maintenance of different servicegenerated equipment?10 Are there preventive maintenance programs for equipment and critical supportsystems?Are performance records for this preventive maintenance program kept?11 Sections 18.18 and 12.11 Is equipment identified as out-of-service or in reparation identified as such? Are they removed from production areas as soon as possible?12 Section 14.46 (c) Is there a preventive maintenance program for the premises?Are there performance records for this preventive maintenance program?13Section14.47 (c)Are records of the usage of critical equipment showed?14 Section 12.1 Is there a preventive maintenance program for quality control equipment? Is there a performance record for this preventive maintenance program?REF:WHO 32 GENERAL SERVICES YES NO15Section15.11Is there a pure steam generator, if necessary?16Section15.11Is there a compressed air generator free of oil, if necessary?17 Sections 15.17Is there an electricity generator for the maintenance of critical systems and processes to be used in case of problems with the electricity supply occur?18Section11.2Are the system generators for different services separated from production areas?19 Do they use gases that will be in direct contact with products?19.1 Are gas piping and valves in good conditions and are they dedicated for each gas?CHAPTER 4 WATER SYSTEMSREF: WHO 32POTABLE WATERYes No NA What is the source of water used in the company?Public Network?Artesian Well, semiartesian well?1Others?2 If necessary, is any treatment for making water potable undertaken before the water isstored?2.1 Does the selected treatment assure potability, according to each country’s requirements?3 Are the system schematics shown?Are the distribution network layouts shown?Are the sampling points shown?4 Does the company have water tanks?4.1 What materials is the water tanks made of?5 Are the cleaning and disinfecting procedures for water and cistern tanks documented?Does the procedure include a justifiable frequency and sampling points?5.1 Are performance records shown?6 Are physicochemical tests of potable water undertaken?Are physicochemical tests of potable water recorded?Indicate frequency7 Is potable water used as a source of purified water or water for injection production?8 Is microbiological control of potable water undertaken?Is microbiological control of potable water recorded?Indicate frequency9 Is potable water used for the initial washing of equipment and tools?10 Is the visible piping used for the transportation of potable water maintained in goodconditions?WHO 32 POTABLE WATER Yes No NA11 Is there a preventive maintenance program that includes the potable water system?Is there a performance record for this preventive maintenance program?REF:WHO 32 PURIFIED WATER Yes No NA1 Is the purified water used, produced by the company?Which is the system used to obtain purified water?Ionic exchange resins?Reverse Osmosis?Distillation?2Others (specify which)?3 Section 17.33 Are the system schematics shown?Are the distribution network layouts shown? Are the sampling points shown?4Section17.33What is the production capacity in liters/hour?4.1 What is the average consumption?5Section14.35Are there written procedures for the operation of the system?7Section17.33Is the purified water stored?7.1 What is the reservoir capacity?7.2 Is the reservoir constructed of sanitary type material?8 If purified water remains stored longer than 24 hours, is there any treatment to preventmicrobiological contamination?8.1Section17.33Does the selected treatment prevent microbiological contamination?9 Are the pipes and valves used to distribute purified water made of sanitary material?10Section15.21Are the visible piping used in water distribution maintained in good conditions?11Sections15.2117.42Is the distribution system of purified water sanitized?WHO 32 PURIFIED WATER Yes No NA 11.1 Is there a SOP for the sanitation of purified water storage and distribution system?11.2 What is the sanitation method used?11.3 In the case of an open distribution system that is not used in 24 hours or more, issanitation undertaken the day before its use?11.4 Are records kept?11.5 In the case of chemical sanitation, are sanitizing agent residues tested?11.6 Arethererecords?12 Is there any type of filter in the distribution system?12.1 In the case that filters exist, are they sanitized?12.2 Are the filter sanitation records shown?12.3 Are the filter replacement records shown?12.4 In the case of open distribution system not used in 24 hours or more, is sanitation donethe day before its use?13 Is any other system, to reduce bacterial burden from purified water, used in thedistribution system?Which type?14 Is the purified water used as a raw material to manufacture non-parenteral products?15 Is the purified water used for washing production equipment and utensils?15.1 Is the purified water used for the final rinse of the equipment used in the manufacture ofnon-parenteral products?15.2 Is the purified water used for the final rinse of the equipment used in the manufacture ofnon-parenteral products?16 Is a non-continuous purified water production system used?16.1 Section 17.42 Does each batch or production day release, by Quality control, undergo physicochemical test established official pharmacopoeias or by alternative validated methods?16.2Section17.42Are microbiological controls undertaken on the day of use?16.3 Is an action limit established?16.4 Is the action limit no more than 100 cfu / mL?WHO 32 PURIFIED WATER Yes No NA 16.5 When the action limit is exceeded, is an investigation always undertaken to ensurequality of the batches of products made with such water?16.6 Is the documentation shown?17 Is a continuous system of purified water production used?17.1Section17.42Is there a continuous monitoring of the quality of the purified water?17.2 Is there an automatic system to prevent use of the purified water, if this is out ofspecifications?17.3 If there is an automatic system, is this checked to verify that it is functioning properly?17.4 Are physicochemical analyses undertaken daily or with an established frequencyaccording to the procedures established by current editions of official pharmacopoeias orby alternative validated methods?17.5 Are microbiological analysis undertaken on the days of use or with an establishedfrequency which is properly validated?17.6 Is an action limit established?17.7 Is the action limit no more than 100 cfu / mL?17.8 When the action limit is exceeded, is an investigation always undertaken to ensurequality of the batches of product made with that water?17.9 Is the documentation shown?18Section17.42Are the sampling points rotated to cover all points of use?19 Is there a SOP for sampling?20 If the water that feeds the system is chlorinated, is there a system to remove thechlorine?21 Are ionic exchange resins used?21.1 Section 17.42 Is there a SOP that considers the criteria to follow for the regeneration of resins and the frequency of regeneration?21.2Section17.42Are records kept?22 Are there SOPs for the sanitation of the purified water system?22.1 What is the sanitation system used?WHO 32 PURIFIED WATER Yes No NA 22.2 What is the sanitation frequency?22.3 Are records kept?23 Is there a preventive maintenance program that includes the components of the purifiedwater system?23.1 Are records kept?REF:WHO 32 WATER FOR INJECTION Yes No NA1 Which treatment system is used to get Water for Injection?2 Section 17.33Are system schematics shown?Are distribution network layouts shown? Are sampling points shown?3Section14.35Are there written procedures for the operation of the system?4Section17.33What is the production capacity in liters/hour?4.1 What is the average consumption?5 If a reverse osmosis system is used:5.1 Is a two-steps system or double osmosis system used on line?5.2 Is the water that feeds the system pre-treated?5.3 What is the pre-treatment system?5.4 Is the system sanitized?5.4.1 What is the sanitation frequency?5.4.2 Are records kept?5.5 In case that chemical sanitation is undertaken, are sanitizing agent residuesinvestigated?5.5.1 Are records kept?6 If distillation is used:6.1 Is the water that feeds the system pre-treated?WHO 32 WATER FOR INJECTION Yes No NA6.2 Which is the pre-treatment system?____________________________________________________________________________________________________________________________7 Is there a storage tank for the Water used for injection?7.1 Is the tank made of sanitary material?7.2 What is its capacity?7.3 Does it have a hydrophobic vent absolute filter?7.4 Are periodic integrity tests undertaken?7.5 Are records kept?8 Are pipes used in the distribution of Water for Injection up to the point of use?8.1 Are pipes made of sanitary material?8.2 Is there any type of heat exchanger in the system?8.3 If “YES", are there guarantees that the heat exchanger is not a source of contamination?9 Is there a SOP for the sanitation of the water storage and distribution system?9.1 What is the sanitation method used?9.2 What is the sanitation frequency?9.3 Are records kept?9.4 In case of chemical sanitation, is the existence of sanitizing agent residues investigated?9.5 Are records kept?9.6 If sanitation is thermal, is it undertaken periodically by a fluent steam circulation?9.7 Are records kept?10 Section 17.33 If water is not used the same day of its production, is the water maintained above 80 °C or below 4º and with constant recirculation through a loop up to points of use?11 If recirculation is below 4o C, ¿are additional precautions taken to prevent access ofmicrobial contaminants and its proliferation?WHO 32 WATER FOR INJECTION Yes No NA 11.1 What are those precautions?________________________________________________________________________________________________________________________________________________________________________________________11.2 Do the storage and recirculation of the water at this temperature ensure its qualityaccording to its use?12 If the water is produced by reverse osmosis, is there any system to maintain its quality?13 If the company manufactures parenteral products, does it use water for injections as araw material?14 If the company manufactures parenteral products, does it use water for injections for thefinal rinse of equipments and components used in manufacturing?15 Is a non-continuous and non-recirculated production system of Water for injection used?15.1 If this is the case: is water used only during the day of its production?15.2 Is water disposed at end of the day of its production?15.3 Is each batch released by Quality control by physicochemical and bacterial endotoxinstests according to the procedures established by current editions of officialpharmacopoeias or by alternative methods validated?15.4 Are microbiological tests of each batch undertaken?15.5 Is an action limit established?15.6 Is action limit no more than 10 cfu /100mL ?15.7 When the action limit is exceeded, is an investigation of the system always undertaken?15.8 Is the investigation report shown?15.9 Are measures undertaken?15.10 What measures are undertaken?16 Is there a continuous system of for the production of water for injections used?Is there a continuous monitoring of the water quality?16.1Section17.4216.2 Is there an automatic system to prevent the use of the water for injections, if it is out ofspecifications?。
Low Temperature IR measurement of Oi in heavily antimony doped Si via wafer thinning
Semicond.Sci.Technol.12(1997)464–466.Printed in the UK PII:S0268-1242(97)78037-4 Low-temperature(10K)infrared measurement of interstitial oxygen in heavily antimony-doped silicon via wafer thinningQi-Yuan Wang,Tian-Hai Cai,Yuan-Huan Yu and Lan-Ying LinInstitute of Semiconductors,Chinese Academy of Sciences,Beijing100083,People’s Republic of ChinaReceived23September1996,infinal form3December1996,accepted forpublication12December1996Abstract.A new technique is reported for the rapid determination of interstitialoxygen in heavily Sb-doped silicon.This technique includes wafer thinning andlow-temperature10K infrared measurement on highly thinned wafers.Thefinestructure of the interstitial oxygen absorption band around1136cm−1is obtained.Our results show that this method efficiently reduces free-carrier absorptioninterference,allowing a high reliability of measurement,and can be used atresistivities down to1×10−2 cm for heavily Sb-doped silicon.1.IntroductionOxygen is a major impurity which remains in an interstitial state in Czochralski-grown(CZ)silicon.Interstitial oxygen (O i)influences both mechanical strength and,via the intrinsic gettering(IG)process,the minority carrier lifetime of processed silicon wafers.Since much attention has been focused on the application of the IG technique to heavily doped p+and n+substrates to improve p/p+,n/n+ CMOS epitaxial wafer quality[1],precise determination and tightened control of the interstitial oxygen become increasingly important for heavily doped CZ silicon wafers used for VLSI and ULSI application.Fourier transform infrared spectroscopy(FTIR)[2]is widely accepted and used as a non-destructive,inexpensive and accurate technique for routine measurement of the interstitial oxygen concentration in silicon.It consists of the determination of the net absorption of the oxygen local vibrational mode at1106cm−1.Various techniques such as secondary ion mass spectroscopy(SIMS),gas fusion analysis(GFA)and charged particle activation analysis (CPAA)are used to detect the total oxygen concentration in silicon.Unfortunately,the interstitial oxygen concentration in heavily doped p+and n+silicon substrates,where resistivity is less than about0.1 cm,cannot be measured by FTIR on wafers of standard thickness due to highly frequency-dependent free-carrier absorption interference. However,with the typical advantages of FTIR,some alternative modified IR-based methods have been proposed to determine oxygen in p+and n+silicon over the past years.Tsuya[3],Ma et al[4]and Wang et al [5]reported the electron and fast neutron irradiation IR methods.However,these methods require prolonged irradiation.A short baseline technique proposed by Oates and Lin[6]may also be used.This technique allows minimization of the oxygen evaluation error due to curvature effects related to free-carrier absorption,but a careful calibration procedure is required.In addition, Borghesi et al[7]recently reported an alternative curved baseline technique with a simpler analytical procedure based on free-carrier absorption computation.Nevertheless, the physical application of FTIR is more easily understood than that of other techniques.We present a new technique for determining Oi in heavily doped silicon,which includes the application of wafer thinning and low-temperature10K FTIR measurement on the highly thinned wafers to measure the Si–O band.Free-carrier absorption effects are reduced by wafer thinning and a high signal-to-noise ratio attained via low-temperature infrared measurement.2.ExperimentThe wafer used was heavily Sb-doped CZ(100)silicon 50–100mm in diameter with a resistivity range of(1–1.4)×10−2 cm and an initial thickness of500–600µm. The wafers were cleaved into15×15mm2square samples. Wafer thinning was carried out by mechanical grinding with boron carbide grindingfluid.Then the thinned samples were mechanochemically polished to obtain the final double-side polished thinned wafers with a thickness of65–200µm(as listed in table1).Thinnedfloat-zone0268-1242/97/040464+03$19.50c 1997IOP Publishing LtdInterstitial oxygen in heavily Sb-doped SiTable1.Low-temperature10K FTIR O i data on thinned wafers of various thickness for heavily Sb-doped silicon.ρSb t O ai Samples(10−3 cm)(1017cm−3)(µm)(1017cm−3)A-214.024.4215 5.10A-713.727.5200 6.09A-412.531.8110 5.47B-111.038.2957.87B-111.038.2857.77B-210.342.065 3.96a Conversion factor at10K:1.79×1016cm−2.(FZ)Si wafers as references were also prepared in an experiment for subtracting the lattice intrinsic absorption from the total absorption so that the net interstitial oxygen absorption can be obtained.Low-temperature infrared measurements were made at10K using a cryostat equipped with a closed-cycle helium refrigerator.The temperature was monitored with a thermocouple which was attached to the cooled sample holder.Infrared spectra in the wavenumber range from1104to1160cm−1were measured with a spectral resolution of0.5cm−1using a Nicolet 170SX Fourier transform infrared spectrometer.Multiple reflection on the thinned wafer samples was taken into account in our calculation of the actual absorption coefficient from infrared transmittance by the multiple-reflection formula[8]and the reflectivity R=0.29is adopted for heavily Sb-doped silicon.The interstitial oxygen concentration[O i]was determined using the conversion factor of1.79×1016cm−2for the10K low-temperature O i peak at1136.4cm−1.The conversion factor is obtained in our lab through a calibration curve which is established by correlating the absorption coefficient of the O i peak at1136.4cm−1at10K with the O i values of a set of standard lightly Sb-doped silicon samples determined at room temperature.At room temperature,the conversion factor is3.14×1017cm−2[9].3.Results and discussionFigures1–3show the low-temperature infrared absorption spectra for heavily Sb-doped thinned silicon samples. At room temperature,with increasing amount of Sb doping the O i absorption band at1106cm−1becomes progressively weaker and just visible on the background with respect to the strong dependence of free-carrier absorption on wavelength[7].Under progressive cooling from room temperature,the1106cm−1band splits and shifts toward higher energies.In the spectra at10K, three peaks at1136.4cm−1,1134.5cm−1and1132.7cm−1 are clearly observed and grouped into the fundamental excitation of the antisymmetric Si–O stretching vibration mode from the ground state of the two-dimensional low-energy anharmonic excitation[10].This multiple splitting originates from the isotope effects due to the silicon lattice,i.e.1136.4cm−1,28Si–16O–28Si;1134.4cm−1,29Si–16O–28Si;1132.7cm−1,30Si–16O–28Si[11].The peak around1128cm−1is attributed to the excitationfrom Figure1.Low-temperature10K infrared absorption spectrum of thinned wafer sampleA-7.Figure2.Low-temperature10K infrared absorption spectra of thinned wafers of sample B-1.thefirst excited state of the two-dimensional low-energy anharmonic excitation[10].As the integrated intensity of the infrared absorption band is nearly the same at room temperature and at10K,the low-temperature O i peak at 1136.4cm−1becomes very sharp and the full width at half-maximum is only about0.7cm−1.Based on thefine structure of the O i peaks,and subtracting the lattice intrinsic absorption and the linear free-carrier absorption background it is convenient to determine the O i concentration reliably from the intensity of the O i peak at1136.4cm−1.Table1lists the O i concentration data for various thinned wafer samples. Those results show that wafer thinning combined with low-temperature measurement on thinned wafers remarkably reduces the infrared absorption due to a high concentration of free carriers and increases the intensity of the transmitted light,so that the signal-to-noise ratio(SNR)of the O i absorption peaks comparatively increases.With respect to other IR-based approaches such as‘short linear baseline’[6] and‘curved baseline’[7]calibration procedures,our465Qi-Yuan Wang etalFigure 3.Low-temperature 10K infrared absorption spectrum of thinned wafer sample B-2.method focused on reduction or elimination of free-carrier absorption interference so that a sharp O i infrared absorption peak is obtained and the reliability of the O i measurement accordingly improved.Furthermore,we noted that for low-temperature measurement the thickness of the thinned wafers has a great influence on infrared spectra (as shown in figures 1–3).When wafer samples are thinned to around 200µm the O i peak at 1136.4cm −1is observed clearly,but the SNR of the infrared spectrum is relatively poor on the whole.If the wafer sample is progressively thinned to about 100µm,the SNR improves noticeably.In particular,for the thinnest wafer sample (as shown in figure 3),the improvement of the SNR is most obvious although it has only 300scans (fewer than 500scans for samples A-7and B-1).Those results indicate that for highly thinned wafer samples of thickness less than 100µm,wafer thinning can efficiently reduce or eliminate the effects of free-carrier absorption on O i determination.For heavily Sb-doped n-type silicon quantitative oxygen measurement by this method can be used for materials with resistivity down to 1×10−2 cm.Nevertheless,for p +silicon (doping concentration more than 4×1018cm −3)the required thickness of thinned wafers is much less than that for n +silicon of the samedopant concentration.This is probably due to the different mechanism of free-carrier (electrons or holes)absorption for n +and p +silicon.Further study is needed to explain this mechanism.4.ConclusionIt has been verified that the concentration of interstitial oxygen in heavily doped CZ silicon can be precisely determined by low-temperature 10K infrared measurement via wafer thinning.This method shows reduced interference due to free-carrier absorption,and the fine structure of interstitial oxygen peaks at 1136.4cm −1has been clearly obtained,thus allowing highly reliable interstitial oxygen measurement.AcknowledgmentWe would like to thank Senior Engineer Xiu-Kun He of 46th Institute,MEI,for his assistance in low-temperature IR analysis.References[1]Borland J O and Deacon T 1984Semicond.Sci.Technol.27123[2]1981Annual Book of ASTM Standards Part 43F121-80[3]Tsuya H,Kanamori M,Takeda M and Yasuda K 1985VLSI Sci.and Tech./1985ed W M Bullis and S Broydo (Penningston,NY:The Electrochemical Society)p 517[4]Ma Z Y,Wang Q Y,Zan Y D,Cai T H,Yu Y H and LinL Y 1994Chinese J.Semicond.15217[5]Wang Q Y,Ma Z Y,Zan Y D,Cai T H,Yu Y H and LinL Y 1994Proc.3rd Int.Conf.on Materials and Process Characterization for VLSI 1994(Kunming,7–11Nov 1994)ed X F Zong,M K Balazs and J J Wang (Shanghai:Asia-Pacific Microanalysis Association)p 144[6]Oates A S and Lin W 1989J.Crystal Growth 89117[7]Borghesi A and Geddo M,Guizzetti G,and Geranzani P1990J.Appl.Phys.681655[8]Grapner R K 1983Silicon Processing ed D C Gupta(Philadelphia,PA:American Society for Testing and Materials)p 459[9]Shirai H 1992J.Electrochem.Soc.1393272[10]Yamada-Kaneta H,Kaneta C and Ogawa T 1990Phys.Rev.B 429650[11]Stavola M 1984Appl.Phys.Lett.44514466。
Agilent E4980A精密LCR测量仪用户指南第八版说明书
Agilent E4980A Precision LCR MeterUser’s GuideEighth EditionFIRMWARE REVISIONSThis manual applies directly to instruments that have the firmware revision A.02.11.For additional information about firmware revisions, see Appendix A.Manufacturing No. E4980-90080June 2010 1981NoticesThe information contained in this document is subject to change without notice.This document contains proprietary information that is protected by copyright. All rights are reserved. No part of this document may be photocopied, reproduced, or translated to another language without the prior written consent of Agilent Technologies.Microsoft®, MS-DOS®, Windows®, Visual C++®, Visual Basic®, VBA®, and Excel®are registered trademarksUNIX is a registered trademark in the U.S. and other countries, licensedexclusively through X/Open Company Limited.Portions ©Copyright 1996, Microsoft Corporation. All rights reserved.© Copyright 2006, 2008, 2010 Agilent TechnologiesManual Printing HistoryThe manual’s printing date and manufacturing number indicate its current edition. The printing date changes when a new edition is printed (minor corrections and updates that are incorporated at reprint do not cause the date to change). The manufacturing number changes when extensive technical changes are incorporated.March 2006 First Edition (manufacturing number: E4980-90000)July 2006 Second Edition (manufacturing number: E4980-90010)November 2006 Third Edition (manufacturing number: E4980-90020)May 2007 Fourth Edition (manufacturing number: E4980-90030)July 2007 Fifth Edition (manufacturing number: E4980-90050)October 2007 Sixth Edition (manufacturing number: E4980-90060)June 2008 Seventh Edition (manufacturing number: E4980-90070)June 2010 Eighth Edition (manufacturing number: E4980-90080)The latest manuals can be downloaded from the following site./find/e4980a/2Safety SummaryThe following general safety precautions must be observed during all phases of operation,service, and repair of this instrument. Failure to comply with these precautions or withspecific WARNINGS elsewhere in this manual may impair the protection provided by theequipment. Such noncompliance would also violate safety standards of design,manufacture, and intended use of the instrument. Agilent Technologies assumes no liabilityfor the customer’s failure to comply with these precautions.NOTE The E4980A complies with INSTALLATION CATEGORY II as well as POLLUTION DEGREE 2 in IEC61010-1. The E4980A is an INDOOR USE product.NOTE The LEDs in the E4980A are Class 1 in accordance with IEC60825-1,CLASS 1 LED PRODUCT•Ground the InstrumentTo avoid electric shock, the instrument chassis and cabinet must be grounded with thesupplied 3-pole power cable’s grounding prong.•DO NOT Operate in an Explosive AtmosphereDo not operate the instrument in the presence of inflammable gasses or fumes.Operation of any electrical instrument in such an environment clearly constitutes asafety hazard.•Keep Away from Live CircuitsOperators must not remove instrument covers. Component replacement and internaladjustments must be made by qualified maintenance personnel only. Do not replacecomponents with the power cable connected. Under certain conditions, dangerousvoltage levels may remain even after the power cable has been disconnected. To avoidinjuries, always disconnect the power and discharge circuits before touching them.•DO NOT Service or Adjust the Instrument AloneDo not attempt internal service or adjustment unless another person, capable ofrendering first aid and resuscitation, is present.•DO NOT Substitute Parts or Modify the InstrumentTo avoid the danger of introducing additional hazards, do not install substitute parts orperform unauthorized modifications to the instrument. Return the instrument to anAgilent Technologies Sales and Service Office for service and repair to ensure thatsafety features are maintained in operational condition.•Dangerous Procedure WarningsWarnings in this manual, such as the example below, precede potentially dangerousprocedures. Instructions contained in the warnings must be followed.WARNING Dangerous voltage levels, capable of causing death, are present in this instrument.Use extreme caution when handling, testing, and adjusting this instrument.34Safety SymbolsGeneral definitions of safety symbols used on the instrument or in manuals are listedbelow.Instruction Manual symbol: the product is marked with this symbol when it is necessary forthe user to refer to the instrument manual.Alternating current.Direct current.On (Supply).Off (Supply).In-position of push-button switch.Out-position of push-button switch.A chassis terminal; a connection to the instrument’s chassis, which includes all exposedmetal structure.Stand-by.WARNING This warning sign denotes a hazard. It calls attention to a procedure, practice, or condition that, if not correctly performed or adhered to, could result in injury or death to personnel.CAUTION This Caution sign denotes a hazard. It calls attention to a procedure, practice, or condition that, if not correctly performed or adhered to, could result in damage to or destruction of part or all of the instrument.NOTE This Note sign denotes important information. It calls attention to a procedure, practice, or condition that is essential for the user to understand.CertificationAgilent Technologies certifies that this product met its published specifications at the timeof shipment from the factory. Agilent Technologies further certifies that its calibrationmeasurements are traceable to the United States National Institute of Standards andTechnology, to the extent allowed by the Institution’s calibration facility or by thecalibration facilities of other International Standards Organization members.WarrantyThis Agilent Technologies instrument product is warranted against defects in material andworkmanship for a period corresponding to the individual warranty periods of itscomponent products. Instruments are warranted for a period of one year. During thewarranty period, Agilent Technologies will, at its option, either repair or replace productsthat prove to be defective.For warranty service or repair, this product must be returned to a service facility designatedby Agilent Technologies. The buyer shall prepay shipping charges to Agilent Technologies,and Agilent Technologies shall pay shipping charges to return the product to the Buyer.However, the Buyer shall pay all shipping charges, duties, and taxes for products returnedto Agilent Technologies from another country.Agilent Technologies warrants that its software and firmware designated by AgilentTechnologies for use with an instrument will execute its programming instruction whenproperly installed on that instrument. Agilent Technologies does not warrant that theoperation of the instrument, or software, or firmware, will be uninterrupted or error free.Limitation of WarrantyThe foregoing warranty shall not apply to defects resulting from improper or inadequatemaintenance by the Buyer, Buyer-supplied software or interfacing, unauthorizedmodification or misuse, operation outside the environmental specifications for the product,or improper site preparation or maintenance.IMPORTANT No other warranty is expressed or implied. Agilent Technologies specifically disclaims the implied warranties of merchantability and fitness for a particular purpose.Exclusive RemediesThe remedies provided herein are the Buyer’s sole and exclusive remedies. AgilentTechnologies shall not be liable for any direct, indirect, special, incidental, orconsequential damages, whether based on contract, tort, or any other legal theory.5AssistanceProduct maintenance agreements and other customer assistance agreements are availablefor Agilent Technologies products.For any assistance, contact your nearest Agilent Technologies Sales and Service Office.Addresses are provided at the back of this manual.Typeface ConventionsSample (bold)Boldface type is used for emphasis.Sample (Italic)Italic type is used for emphasis and manual title.[Sample] key Indicates a hardkey (key on the front panel orexternal keyboard) labeled “Sample.” “key” maybe omitted.Sample menu/button/box Indicates a menu/button/box on the screen labeled“Sample” that can be selected/executed byclicking “menu,” “button,” or “box,” may beomitted.Sample 1 - Sample 2 - Sample 3Indicates a sequential operation of Sample 1,Sample 2, and Sample 3 (menu, button, or box).“-” may be omitted.Documentation MapThe following manuals are available for the Agilent E4980A.•User’s Guide (Manufacturing Number E4980-900x0, attached to Option ABA,English)This manual describes most of the basic information on the E4980A. It provides adetailed operation procedure for each function (from the function overview to systemsettings), measurement examples, options, accessories, specifications, GPIBcommands, function lists by softkeys, and error messages.NOTE The number position shown by “x” in the manufacturing number above indicates theedition number.6Sample ProgramsThe customer shall have the personal, nontransferable rights to use, copy, or modify SAMPLE PROGRAMS in this manual for the Customer’s internal operations. The customer shall use the SAMPLE PROGRAMS solely and exclusively for their own purpose and shall not license, lease, market, or distribute the SAMPLE PROGRAMS or modifications of any part thereof.Agilent Technologies shall not be liable for the quality, performance, or behavior of the SAMPLE PROGRAMS. Agilent Technologies especially disclaims that the operation of the SAMPLE PROGRAMS shall be uninterrupted or error free. The SAMPLE PROGRAMS are provided AS IS.AGILENT TECHNOLOGIES DISCLAIMS IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.Agilent Technologies shall not be liable for any infringement of any patent, trademark, copyright, or other proprietary rights by the SAMPLE PROGRAMS or their use. Agilent Technologies does not warrant that the SAMPLE PROGRAMS are free from infringements of such rights of third parties. However, Agilent Technologies will not knowingly infringe or deliver software that infringes the patent, trademark, copyright, or other proprietary right of a third party.78Contents 1.Unpacking and PreparationChecking the Shipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Preparations before Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Verifying the Power Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Setting up the Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Verifying and Connecting the Power Cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 How to Remove the Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Caution when Using the Handle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Environmental Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Operating Environments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Ventilation Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Protection Against Electrostatic Discharge (ESD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Ensuring Adequate Free Space around the LCR meter for Immediate Disconnection of the Power Cable in Case of Emergency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Starting the E4980A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Turning the Power ON and OFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Disconnecting from the Supply Source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 2.OverviewProduct Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Front Panel: Names and Functions of Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391. Power switch. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 402. LCD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403. Softkeys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404. Menu keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 405. Cursor keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 406. Entry keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 407. LED indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 418. Preset key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 419. Trigger key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4110. DC Bias key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4111. DC Source key. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4112. UNKNOWN terminals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4113. Front USB port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4214. Ground terminal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4215. DC Source terminal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Rear Panel: Names and Functions of Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 431. GPIB Interface Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 432. Interface Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 433. USB (USBTMC) Interface Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 444. LAN Port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 445. External Trigger Input Connector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 446. Serial Number Plate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 447. Power Cable Receptacle (to LINE). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 448. Fan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Screen Area: Names and Functions of Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 461. Display Page Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 462. Comment Line Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 463. Softkey Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 479Contents4. Measurement Data/Conditions Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 475. Input Line Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 486. System Message Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 487. Status Display Area. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Basic Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 How to Use Cursor Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 How to Use Skip Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 3.Display FormatMEAS DISPLAY Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Measurement Function. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Impedance range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Test Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Test Signal Level. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66 DC Bias. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Measurement Time Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Display Setting for Measurement Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 Displaying Errors instead of Measurement Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Monitor Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 BIN NO. DISPLAY Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Comparator Function ON/OFF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 BIN COUNT DISPLAY Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Counter Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 LIST SWEEP DISPLAY Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Sweep Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 DISPLAY BLANK Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 4.Configuring Measurement Conditions (Display and Function Related Settings)Initializing the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 MEAS SETUP page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Comment line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Trigger mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 Automatic level control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 DC Bias Current Isolation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Averaging Factor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Trigger Delay Time. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Step Delay Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104 DC Bias V oltage Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 DC Bias Current Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107 DCR Range. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 DCI Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 DC Source. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Automatic Bias Polarity Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Deviation Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113 CORRECTION page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115 To set the correct function to on or off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116 The correction functions of the E4980A are operated as follows:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 Open Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118 10Short Correction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121 Correction Based on User-Specified Frequency Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Relationships between Correction Based on All Frequency Points and Correction Based on SpecifiedFrequency Points. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 Reading/Writing Correction Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Measurement Functions for the Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 Selecting Single/Multiple Correction Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Selecting the Cable Length. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 LIMIT TABLE SETUP Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Parameter Swap Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 Comparator Limit Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Tolerance Mode Nominal Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Turning On/Off the Comparator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 Turning On/Off the Auxiliary Bin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 Beep Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142 Lower and Upper Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143 LIST SWEEP SETUP Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 Sweep Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 List Sweep Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 Sweep Points and Limit Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 Sweep Parameter Auto-completion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 5.System ConfigurationsSYSTEM INFO Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 Bias Current Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Handler Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158 Scanner Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Monitor Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 SYSTEM CONFIG Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Turning On/Off the Beep Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 Changing the Beep Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 Changing the Beep Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163 Configuring the Time Zone. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Configuring the System Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165 Configuring the GPIB Address. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167 Configuring the LAN IP address. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 SELF TEST Page . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 171 Choosing a Test Item. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 SERVICE Page. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173 Monitor Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 Saving the System Information into External Memory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 6.Save/RecallOverview of Save/Recall Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 Save Methods and Their Uses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 Folder/File Structure on USB Memory. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 USB Memory Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177 Saving/Recalling Instrument Configuration States. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178。
calibration
标准件的追溯性
Standard Traceability
Metrology Equipment & tools
Standard wafer
Calibration Lab
Vendor
VLSI(USA)
校准之标准件
Calibration Standards
Alpha step height Dektak250 Standard wafer Filmmetrics F50 SiO2 on Si Standard wafer 4PPsurface resistance RT-70V standard BST DAGE4000 standard weight Spectrometer S-3100T Standard wafer polished both sides
测量设备标准件的管理程序
Metrology Equipment Standard Management Procedure
*****Copyright and Business Secret belong to Elec-Tech Photoelectric Technology(Dalian). Don’t Copy Without Permission.*****
校准定义:
在规定条件下,为确定测量仪器仪表或者测量系统所指示的量值,或实物量具或参考物质所代表的量值与对应的标准件所复现的量值 之间关系的一组操作。通常人们是按照明确的,由文件规定的步骤来进行的一组操作,用以把一台仪器的已知值,通过比它更为精确的仪 器或者标准进行测量后,并加以比较,从而探测和报告被测量仪器的误差,或者通过调节来消除被测量仪器误差的一组过程。 标准件(Standard):可追溯到国家标准,国际标准或者厂商的测量标准件,用来对测量设备&仪器等进行周期测量的量具。
透射式烟度计的检定规程及操作指南
透射式烟度计的检定规程及操作指南Transmissive smoke meter calibration procedureThe calibration procedure for a transmissive smoke meter involves several steps to ensure accurate and reliable measurements. Here is a brief overview of the process:1. Equipment preparation: Before starting the calibration, ensure that the transmissive smoke meter is clean and in proper working condition. Check for any damage or malfunctions.2. Calibration standards: Obtain a set of calibration standards that cover a range of smoke levels. These standards should be traceable to a national or international standard.3. Zero calibration: Perform a zero calibration by measuring the smoke level in clean air. Adjust the meter's zero level if necessary, ensuring that it reads zero in the absence of smoke.4. Span calibration: Use the calibration standards to performa span calibration. Measure the smoke levels at differentconcentrations and adjust the meter's span level accordingly.5. Verification: After calibration, verify the accuracy of the transmissive smoke meter by measuring the smoke levels in reference samples with known smoke concentrations. Compare the readings with the expected values.6. Documentation: Record all calibration and verification results in a calibration log or certificate, including the date, technician's name, equipment details, calibration standards used, and measurement values.7. Regular calibration: It is important to regularly calibrate the transmissive smoke meter to maintain accuracy. Follow the manufacturer's recommended calibration interval or any applicable regulations.中文回答:透射式烟度计检定规程透射式烟度计的检定规程涉及多个步骤,以确保准确可靠的测量结果。
水轮机电液调节系统及装置技术规程(英文版)
水轮机电液调节系统及装置技术规程(英文版)以下是为您生成的二十个关于水轮机电液调节系统及装置技术规程相关的英语释义、短语、单词、用法及双语例句:---1. **“水轮机电液调节系统”**:Hydroelectric turbine electro-hydraulic regulating system- 释义:用于控制水轮机运行的电液结合的调节系统- 短语:optimize the hydroelectric turbine electro-hydraulic regulating system(优化水轮机电液调节系统)- 单词:hydroelectric(水电的)、turbine(涡轮机、水轮机)、electro-hydraulic(电液的)、regulating(调节)- 用法:This paper focuses on the performance of the hydroelectric turbine electro-hydraulic regulating system.(这篇论文关注水轮机电液调节系统的性能。
)- 双语例句:The stability of the hydroelectric turbine electro-hydraulic regulating system is crucial for efficient power generation.(水轮机电液调节系统的稳定性对于高效发电至关重要。
)2. **“装置”**:Device / Installation- 释义:设备、仪器;安装、设置- 短语:testing device(测试装置)、installation procedure(装置安装程序)- 单词:test(测试)、procedure(程序、步骤)- 用法:The new device has improved the efficiency of the system.(新装置提高了系统的效率。
CALIBRATION PROCEDURE
CALIBRATION PROCEDUREB/E/M/S/X SeriesFor NI-DAQ™mxThis document contains instructions for calibrating National InstrumentsB, E, M, S, and X Series data acquisition (DAQ) devices.This document does not discuss programming techniques or compilerconfiguration. The NI-DAQmx driver contains online help files that havecompiler-specific instructions and detailed function explanations. Youcan add these help files when you install NI-DAQmx on the calibrationcomputer.ContentsConventions (2)Software (3)Documentation (3)Calibration Interval (4)Password (4)Test Equipment (4)Test Conditions (6)Calibration Procedure (6)Initial Setup (7)Self-Calibration (7)Checking Device Temperature Changes (8)Verification Procedure (9)Analog Input Verification (10)Analog Output Verification (15)Counter Verification (18)Adjustment Procedure (20)Test Limits (23)B Series Test Limits (25)NI6010—16-Bit Resolution (25)NI6013/6014/6015/6016—16-Bit Resolution (27)B/E/M/S/X Series Calibration Procedure E Series Test Limits (29)NI 6011E—16-Bit Resolution (29)NI 6023E/6024E/6025E—12-Bit Resolution (31)NI DAQCard-6024E—12-Bit Resolution (33)NI 6030E/6031E/6032E/6033E—16-Bit Resolution (35)NI 6034E/6035E/6036E—16-Bit Resolution (38)NI DAQCard-6036E—16-Bit Resolution (40)NI 6040E—12-Bit Resolution (42)NI 6052E—16-Bit Resolution (45)NI DAQCard-6062E—12-Bit Resolution (48)NI 6070E/6071E—12-Bit Resolution (51)M Series Test Limits (54)NI USB-6210/6211/6215/6218—16-Bit Resolution (54)NI USB-6212/6216—16-Bit Resolution (56)NI 6220/6221/6224/6225/6229—16-Bit Resolution (58)NI 6250/6251/6254/6255/6259—16-Bit Resolution (60)NI 6280/6281/6284/6289—18-Bit Resolution (63)S Series Test Limits (67)NI 6110/6111—12-Bit Resolution (67)NI 6115—12-Bit Resolution (69)NI 6120—16-Bit Resolution (71)NI 6122/6123—16-Bit Resolution (73)NI PXIe-6124—16-Bit Resolution (74)NI 6132/6133—14-Bit Resolution (76)NI 6143—16-Bit Resolution (77)X Series Test Limits (78)NI 632x —16-Bit Resolution (78)NI 634x —16-Bit Resolution (80)NI 6351/6353—16-Bit Resolution (82)NI 6356/6358/6366/6368—16-Bit Resolution (84)NI 6361/6363—16-Bit Resolution (86)ConventionsThe following conventions are used in this manual:»The » symbol leads you through nested menu items and dialog box optionsto a final action. The sequence File»Page Setup»Options directs you topull down the File menu, select the Page Setup item, and select Optionsfrom the last dialog box.This icon denotes a note, which alerts you to important information.This icon denotes a caution, which advises you of precautions to take toavoid injury, data loss, or a system crash.When this symbol is marked ona product, refer to the Read Me First: Safety and ElectromagneticCompatibility for information about precautions to take.bold Bold text denotes items that you must select or click in the software, suchas menu items and dialog box options. Bold text also denotes parameternames and hardware labels.italic Italic text denotes variables, emphasis, a cross-reference, or an introductionto a key concept. Italic text also denotes text that is a placeholder for a wordor value that you must supply.monospace Monospace text denotes text or characters that you should enter from thekeyboard, sections of code, programming examples, and syntax examples.This font is also used for the proper names of disk drives, paths, directories,programs, subprograms, subroutines, device names, functions, operations,variables, filenames, and extensions.monospace italic Italic text in this font denotes text that is a placeholder for a word or valuethat you must supply.Platform Text in this font denotes a specific platform and indicates that the textfollowing it applies only to that platform.SoftwareCalibration requires the latest NI-DAQmx driver. NI-DAQmx includeshigh-level function calls to simplify the task of writing software to calibratedevices. The driver supports many programming languages, includingLabVIEW, LabWindows™/CVI™, C/C++, C#, and Visual Basic .NET. DocumentationThe following documents are your primary references for writing yourcalibration utility with NI-DAQmx:•The DAQ Getting Started guides for NI-DAQ 9.0 or later providesinstructions for installing and configuring NI-DAQ devices.NI USB-621x users should refer to the NI-DAQmx for USB DevicesGetting Started Guide.•The NI-DAQmx Help includes information about creating applicationsthat use the NI-DAQmx driver.•The NI-DAQmx C Reference Help includes information about thefunctions in the driver.© National Instruments Corporation3B/E/M/S/X Series Calibration ProcedureB/E/M/S/X Series Calibration Procedure • E Series Calibration Fixture Installation Guide provides informationon installing and operating the E/M/S Series calibration hardwareadapter.•The NI 6010 Help , E Series User Manual , M Series User Manual ,NI USB-621x User Manual , S Series User Manual , NI 6124/6154 UserManual , or X Series User Manual provides information about yourDAQ device.•The specifications document for your DAQ device provides detailed specifications.Calibration IntervalB/E/M/S/X Series devices should be calibrated at a regular interval asdefined by the measurement accuracy requirements of your application.National Instruments recommends that you routinely perform a completecalibration at least once every year (once every two years for someM/S/X Series devices). You can shorten this interval based on the accuracydemands of your application or requirements of your processes.PasswordThe default password for password-protected operations is NI .Test EquipmentNational Instruments recommends that you use the instruments in Table 1for calibrating a B/E/M/S/X Series device.CautionFor compliance with Electromagnetic Compatibility (EMC) requirements, thisproduct must be operated with shielded cables and accessories. If unshielded cables or accessories are used, the EMC specifications are no longer guaranteed unless allunshielded cables and/or accessories are installed in a shielded enclosure with properly designed and shielded input/output ports.Table 1. Recommended Equipment EquipmentRecommended Model Requirements Calibrator Fluke 5700A If this instrument is unavailable, use a high-precision voltagesource that is at least 50ppm (0.005%) accurate for12-bit devices, and 10ppm (0.001%) accurate for 14-, 16-,and 18-bit devices.DMM NI 4070If this instrument is unavailable, use a multiranging 61/2-digitDMM with an accuracy of 40ppm.© National Instruments Corporation 5B/E/M/S/X Series Calibration Procedure CounterAgilent 53131A If this instrument is unavailable, use a counter accurate to 0.01%.PXI chassisNI PXI-1042, NI PXI-1042Q Use with PXI modules.PXI Express chassisNI PXIe-1062Q Use with PXI Express modules.Low thermal copperEMF plug-in cableFluke 5440A-7002Do not use standard banana cables.Shielded DAQ cable NI SH68-68-EP,NI SH68-68-EPMUse with B/E/M/S Series devices with 68-pin SCSI II connectors.NI SHC68-68-EP,NI SHC68-68-EPM,NI SHC68-68Use with E/M/S/X Series devices with 68-pin VHDCI connectors.NI SH1006868Use with E Series devices with 100-pin connectors.*NI SH37F-37M-1Use with B/M Series devices with 37-pin D-SUB connectors.DAQ accessory NI E/M/S Series calibrationhardware adapter Connects your calibration equipment to your 68-pin E/M/S/X Series device.If you programmatically control this fixture, you will not need todisconnect and reconnect cables at each step of the procedure.†(NI 61xx Devices) S Series devices must use revision B or later ofthe calibration adapter.NI SCC-68I/O connector block with screw terminals, general breadboardarea, bus terminals, and four expansion slots for SCC signalconditioning modules.NI SCB-68Shielded I/O connector block with 68screw terminals for easysignal connection to 68- or 100-pin DAQ devices.NI CB-68LP, NI CB-68LPR, NI TBX-68Low-cost termination accessories with 68screw terminals foreasy connection of field I/O signals to 68-pin DAQ devices.NI BNC-2110Desktop and DIN rail-mountable BNC adapter you can connectto DAQ devices.NI CB-37F-LPLow-cost termination accessory with 37screw terminals for easyconnection of field I/O signals to 37-pin DAQ devices.* Connect the 68-pin cable labeled MIO-16 to the accessory. The 68-pin cable labeled Extended I/O remains unconnected.† For M/S/X Series devices with two connectors, you will need to disconnect the calibration equipment from Connector 0 and reconnect to Connector 1 midway through the verification procedure.Table 1. Recommended Equipment (Continued)EquipmentRecommended Model RequirementsTest ConditionsFollow these guidelines to optimize the connections and the environmentduring calibration.•Keep connections to the device as short as possible. Long cables andwires can act as antennae, which could pick up extra noise that wouldaffect measurements.•Use shielded copper wire for all cable connections to the device.Use twisted-pair wire to eliminate noise and thermal offsets.•Maintain the ambient temperature between 18 and 28°C. The devicetemperature will be greater than the ambient temperature. Refer to theCalibration Procedure section for more information about calibrationtemperatures and temperature drift.•For valid test limits, maintain the device temperature within ±1 °Cfrom the last self-calibration and ±10 °C from the last externalcalibration.•Keep relative humidity below 80%.•Allow adequate warm-up time (generally between 15 and 30minutesfor most DAQ devices) to ensure that the measurement circuitry is at astable operating temperature. Refer to your DAQ device specificationsdocument for the recommended warm-up time for your device. Calibration ProcedureThe calibration process has six steps.1.Initial Setup—Configure your device in NI-DAQmx.2.Self-Calibration—Adjust the self-calibration constants of the device.3.Checking Device Temperature Changes—Verify that the currentdevice temperature will not cause you to incorrectly calibrate yourdevice.4.Verification Procedure—Verify the existing operation of the device.This step allows you to confirm that the device was operating withinits specified range prior to calibration.5.Adjustment Procedure—Perform an external calibration that adjuststhe device calibration constants with respect to a known voltagesource.6.Reverification—Perform another verification to ensure that the deviceis operating within its specifications after adjustment.B/E/M/S/X Series Calibration These steps are described in detail in the following sections. Although NIrecommends that you verify all ranges, you can save time by checking onlythe ranges used in your application.Initial SetupThe device must be configured in Measurement & Automation Explorer(MAX) to communicate with NI-DAQmx.Complete the following steps to configure a device in MAX.1.Install the NI-DAQmx driver software.2.Power off the host computer or chassis that will hold the device andinstall the device.3.Power on the computer or chassis and launch Measurement &Automation Explorer (MAX).4.Configure the device identifier and select Self-Test to ensure that thedevice is working properly.Note When a device is configured with MAX, it is assigned a device identifier. Eachfunction call uses this identifier to determine which DAQ device to calibrate.Self-CalibrationSelf-calibration should be performed after the device has warmed up for therecommended time period—generally between 15 and 30minutes for mostDAQ devices. Refer to your DAQ device specifications document for therecommended warm-up time for your device. Call self-calibration beforedoing the first verification. This function measures the onboard referencevoltage of the device and adjusts the self-calibration constants to accountfor any errors caused by short-term fluctuations in the environment.Disconnect all external signals when you self-calibrate a device.LabVIEW Block DiagramNI-DAQmx Function Call Call DAQmxSelfCal with the following parameter:deviceName: dev1© National Instruments Corporation7B/E/M/S/X Series Calibration ProcedureB/E/M/S/X Series Calibration Procedure You also can initiate self-calibration using MAX, by completing thefollowing steps.1.Launch MAX.2.Select My System»Devices and Interfaces»NI-DAQmx Devices»your device .3.Initiate self-calibration using one of the following methods:•Click Self-Calibrate in the upper right corner of MAX.•Right-click the name of the device in the MAX configuration treeand select Self-Calibrate from the drop-down menu.Checking Device Temperature ChangesDevice temperature changes (greater than ±10 °C since the previousexternal calibration or greater than ±1 °C since the previousself-calibration) can cause you to incorrectly calibrate your device. Afterself-calibrating your device (as described in the Self-Calibration section),complete the following steps to compare the current device temperature tothe temperatures measured during the last self-calibration and externalcalibration.1.Read the current temperature measured by the device by using theDevTemp property node.2.Get the temperature of the device recorded during the lastself-calibration by using the stTemp property node.If the difference between the current temperature and the temperaturefrom the last self-calibration is greater than 1 °C, the limits in thecalibration tables are not valid. LabVIEW Block DiagramNI-DAQmx Function Call Call DAQmxGetCalDevTempwith thefollowing parameter:deviceName : dev1LabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxGetSelfCalLastTemp withthe following parameter:deviceName : dev1© National Instruments Corporation 9B/E/M/S/X Series Calibration Procedure3.Get the temperature of the device recorded during the last externalcalibration by using the stTemp property node.If the difference between the current temperature and the temperaturefrom the last external calibration is greater than 10 °C, the limits in thecalibration tables are not valid. Note The maximum temperature change for most DAQ devices is ±10 °C. To find the valid temperature drifts for your B/E/M/S/X device, refer to the Absolute Accuracy table(s) in your DAQ device specifications document.Note You also can read the current device temperature, the temperature during the last self-calibration, and the temperature during the last external calibration in MAX. Launch MAX, select My System»Devices and Interfaces»NI-DAQmx Devices» your device , then click the Calibration tab.If the device temperature is outside the maximum range, you should chooseone of the following options:•Change the test limits to include the additional error due to temperaturedrift. Refer to your DAQ device specifications document for moreinformation.•Change the system so that the temperature will be closer to thetemperature recorded during the last external calibration.Verification ProcedureVerification determines how well the DAQ device is meeting itsspecifications. By performing this procedure, you can see how your devicehas operated over time. You can use this information to help determine theappropriate calibration interval for your application.The verification procedure is divided into the major functions of the device.Throughout the verification process, use the tables in the Test Limitssection to determine if your device needs to be bVIEW Block DiagramNI-DAQmx Function CallCall DAQmxGetExtCalLastTemp withthe following parameter:deviceName :dev1B/E/M/S/X Series Calibration Procedure Analog Input VerificationSince B/E/M/S/X Series devices have many different ranges, you mustcheck measurements for each available range.(B/E/M/X Series [MIO] Devices) Because there is only one analog-to-digitalconverter (ADC) on B/E/M Series and X Series NI 632x /634x /6351/6353/6361/6363 devices, you must perform verification on all ranges of oneanalog input channel in differential mode. (Optional) Then, performverification on one range of all remaining analog input channels indifferential mode to verify that the device mux and analog input lines areoperating properly.(S/X Series [Simultaneous MIO] Devices) You must perform verificationon all ranges of all analog input channels of S Series and X SeriesNI 6356/6358/6366/6368 devices in differential mode.Note The test limits used in this document assume a maximum temperature drift of±10°C from the last external calibration, and a maximum temperature drift of ±1°C from the last self-calibration. Refer to the Calibration Procedure section for more information and instructions on reading your device temperature and comparing it against the device temperature during the last external calibration.Complete the following steps to check the performance of the analog input.1.Connect the calibrator to the device. Refer to Table 2 to determineconnections between the device and the calibrator.Note If your calibrator has a guard connection, connect that terminal to AI GND. If your calibrator does not have a guard connection and has a floating output, connect the negative output to AI GND. If the calibrator output is not floating, do not make any other connections. For more information, refer to the user documentation for the device you are using. If you are using the E/M/S Series calibration hardware adapter, connect the device as described in the E Series Calibration Fixture Installation Guide .Note (NI USB-6215/6216/6218 Devices) For isolated devices, if the calibrator outputs are truly floating, the negative output must be connected to a quiet earth ground as well as AIGND to give the entire system a ground reference.Table 2. Analog Input ConnectionsDeviceCalibratorPositive Output*Negative Output*Guard Connection†B/E/M/X Series (MIO)‡AI0 (pin68)**AI8 (pin34)†, **AI GND (pin67)†, **S/X Series (Simultaneous MIO)††Connector 0AI0 + (pin68)AI0 – (pin34)†AI 0 GND (pin 67)†AI1 + (pin33)AI1 – (pin66)†AI 1 GND (pin 32)†AI2 + (pin65)AI2 – (pin31)†AI 2 GND (pin 64)†AI3 + (pin30)AI3 – (pin63)†AI 3 GND (pin 29)†AI4 + (pin28)AI4 – (pin61)†AI 4 GND (pin 27)†AI5 + (pin60)AI5 – (pin26)†AI 5 GND (pin 59)†AI6 + (pin25)AI6 – (pin58)†AI 6 GND (pin 24)†AI7 + (pin57)AI7 – (pin 23)†AI 7 GND (pin 56)†X Series (Simultaneous MIO)‡‡Connector 1AI8 + (pin68)AI8 – (pin34)†AI 8 GND (pin 67)†AI9 + (pin33)AI9 – (pin66)†AI 9 GND (pin 32)†AI10 + (pin65)AI10 – (pin31)†AI 10 GND (pin 64)†AI11 + (pin30)AI11 – (pin63)†AI 11 GND (pin 29)†AI12 + (pin28)AI12 – (pin61)†AI 12 GND (pin 27)†AI13 + (pin60)AI13 – (pin26)†AI 13 GND (pin 59)†AI14 + (pin25)AI14 – (pin58)†AI 14 GND (pin 24)†AI15 + (pin57)AI15 – (pin 23)†AI 15 GND (pin 56)†* Pin numbers are given for 68-pin connectors only. If you are using a BNC, DAQPad/USB screw terminal, 34-pin IDC header, 50-pin IDC header, 37-pin, or 100-pin connector, refer to your device user documentation for signal connection locations.† If your calibrator has a guard connection, connect that terminal to AI GND. If your calibrator does not have a guard connection and has a floating output, connect the negative output to AI GND. If the calibrator output is not floating,do not make any other connections. For more information, refer to the user documentation for the device you are using.‡ NI 632x/634x/6351/6353/6361/6363 X Series MIO devices.** You must perform verification on all ranges of one analog input channel in differential mode. (Optional) Then, perform verification on one range of all remaining analog input channels in differential mode to verify that the device mux and analog input lines are operating properly. Refer to your device user documentation for signal connection locations.†† NI 6356/6358/6366/6368 X Series simultaneous MIO devices.‡‡ NI 6358/6368 X Series simultaneous MIO devices.2.Choose the table from the Test Limits section that corresponds with the device you are verifying. This table shows all acceptable settings for the device type. NI recommends that you verify all ranges, although you may want to save time by checking only the ranges used in your application.3.Set the calibrator voltage to the test value indicated in the device table.4.Create a task using DAQmxCreateTask .5.Add a channel to the task using the DAQmx Create Virtual Channel VI and configure the channel. Use the tables in the Test Limits section to determine the minimum and maximum values for your device.Note Throughout the procedure, refer to the NI-DAQmx function call parameters for theLabVIEW input values.LabVIEW Block DiagramNI-DAQmx Function CallLabVIEW does not require this step.Call DAQmxCreateTask with the following parameters:taskName : AIVerificationTask taskHandle : &taskHandleLabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxCreateAIVoltageChan with the following parameters:taskHandle : taskHandle physicalChannel : dev1/ai0nameToAssignToChannel :myVoltageChannelterminalConfig : DAQmx_Val_Cfg_Default minVal : –10.0maxVal : 10.0units : DAQmx_Val_Volts customScaleName : NULL6.(NI 628x Devices) Configure the lowpass filter by setting theAI.Lowpass.Enable property node to True.7.Configure timing for the voltage acquisition using the DAQmx Timing VI.(NI 6011E [PCI-MIO-16XE-50] and NI 6115/6120 Devices) Use 20000.0 for rate and 20000 for sampsPerChan .8.(NI 6023E/6024E/6025E/6040E/6062E Devices) For 12-bit E Series devices,configure dither to be on by setting the AI.Dither.Enable property node to True.LabVIEW Block DiagramNI-DAQmx Function Call CallDAQmxSetChanAttribute with the following parameters:taskHandle: taskHandle Channel : ""Attribute : DAQmx_AI_Lowpass_Enable Value : 0 (filter off) or 1(filter on)LabVIEW Block Diagram NI-DAQmx Function CallCall DAQmxCfgSampClkTiming with the following parameters:taskHandle : taskHandle source : NULLrate : 100000.0 or 20000.0activeEdge : DAQmx_Val_RisingsampleMode : DAQmx_Val_FiniteSamps sampsPerChan : 10000 or 20000LabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxSetAIDitherEnable with the following parameters:taskHandle : taskHandlechannel []: MyVoltageChannel bool32: TRUE9.Start the acquisition using the DAQmx Start Task VI.10.Acquire 10,000 points of voltage data using the DAQmx Read VI.(NI 6011E [PCI-MIO-16XE-50] and NI 6115/6120 Devices) Acquire20,000points of voltage data using the DAQmx Read VI.11.Average the voltage values that you acquired. Compare the resultingaverage to the upper and lower limits listed in the table in the Test Limits section. If the result is between these values, the device passes the test.12.Clear the acquisition using the DAQmx Clear Task VI.13.(B/E/M/X Series [MIO] Devices) Repeat steps 4 through 12 until all valueshave been verified on NI 60xx /60xx E/62xx /632x /634x /6351/6353/6361/6363 devices.(S/X Series [Simultaneous MIO] Devices) Repeat steps 4 through 12 forall channels and all values on NI 61xx /6356/6358/6366/6368 devices.LabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxStartTaskwith the following parameter:taskHandle: taskHandleLabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxReadAnalogF64 with the following parameters:taskHandle : taskHandle numSampsPerChan : –1timeout : 10.0fillMode : DAQmx_Val_GroupByChannel readArray : dataarraySizeInSamples : 10000 or 20000sampsPerChanRead : &read reserved : NULLLabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxClearTask with the following parameter:taskHandle : taskHandle14.Disconnect the calibrator from the device.You have finished verifying the analog input levels on your device.Analog Output VerificationThis procedure checks the performance of all analog output channels. Most B/E/M/S/X Series devices have two analog outputs, AO 0 and AO 1. Some M/X Series devices have four analog outputs, two on each connector. Skip this step if the device you are calibrating does not have analog output circuitry.Note The test limits used in this document assume a maximum temperature drift of±10°C from the last external calibration, and a maximum temperature drift of ±1°C from the last self-calibration. Refer to the Calibration Procedure section for more information and instructions on reading your device temperature and comparing it against the device temperature during the last external calibration.Complete the following steps to check analog output measurements.1.Connect your DMM to AO 0 as shown in Table 3.Note (NI USB-6215/6216/6218 Devices) For isolated devices, you must also connectAO GND to a quiet earth ground reference or the ground reference of the DMM.2.Choose the table from the Test Limits section that corresponds with the device you are verifying. This table shows all acceptable settings for the device. NI recommends that you verify all ranges, although you may want to save time by checking only the ranges used in your application.Table 3. Analog Output ConnectionsAnalog OutputDMMPositive Input *Negative Input *AO 0Connector 0, AO 0 (pin 22)Connector 0, AO GND (pin 55)AO 1Connector0, AO 1 (pin 21)Connector 0, AO GND (pin 55)AO 2Connector 1, AO 2 (pin 22)Connector 1, AO GND (pin 55)AO 3Connector 1, AO3 (pin 21)Connector 1, AO GND (pin 55)* Pin numbers are given for 68-pin connectors only. If you are using a BNC, DAQPad/USB screw terminal, 34-pin IDC header, 50-pin IDC header, 37-pin, or 100-pin connector, refer to your device user documentation for signal connection locations.3.Create a task using DAQmxCreateTask .4.Add an AO voltage task using the DAQmx Create Virtual Channel VI and configure the channel, AO 0. Use the tables in the Test Limits section to determine the minimum and maximum values for your device.Note Throughout the procedure, refer to the NI-DAQmx function call parameters for theLabVIEW input values.5.Start the generation using the DAQmx Start Task VI.LabVIEW Block DiagramNI-DAQmx Function CallLabVIEW does not require this step.Call DAQmxCreateTask with the following parameters:taskName : MyAOVoltageTask taskHandle : &taskHandleLabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxCreateAOVoltageChanwith the following parameters:taskHandle : taskHandle physicalChannel : dev1/ao0nameToAssignToChannel :AOVoltageChannel minVal : –10.0maxVal : 10.0units : DAQmx_Val_Volts customScaleName : NULLLabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxStartTask with the following parameter:taskHandle : taskHandle6.Write a voltage to the AO channel using the DAQmx Write VI.7.Compare the resulting value shown by the DMM to the upper and lower limits in the table in the Test Limits section. If the value is between these limits, the device passes the test.8.Clear the acquisition using the DAQmx Clear Task VI.9.Repeat steps 3 through 8 until all values have been tested.10.Disconnect the DMM from AO 0, and reconnect it to AO 1, making theconnections shown in Table 3.11.Repeat steps 3 through 10 for all AO channels on the device.12.Disconnect your DMM from the device.You have finished verifying the analog output levels on your device.LabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxWriteAnalogF64with the following parameters:taskHandle : taskHandle numSampsPerChan : 1autoStart : 1timeout : 10.0dataLayout : DAQmx_Val_GroupByChannel writeArray : &datasampsPerChanWritten : &samplesWritten reserved : NULLLabVIEW Block DiagramNI-DAQmx Function CallCall DAQmxClearTask with the following parameter:taskHandle : taskHandle。
calibration standards 校
calibration standards 校Calibration Standards: Ensuring Precision and Accuracy in MeasurementIntroduction:Accurate and precise measurements are vital in various industries such as manufacturing, healthcare, and scientific research. These measurements form the basis for making informed decisions, ensuring quality control, and achieving regulatory compliance. However, instruments and devices used for measurements can experience drift or deterioration over time, leading to inaccurate results. To address this issue, calibration standards have been developed to maintain the accuracy and reliability of measuring instruments. In this article, we will explore what calibration standards are, how they work, and their importance in various fields.What are Calibration Standards?Calibration standards are reference instruments or materials that are used to calibrate or align measurement tools to a known andtraceable standard, ensuring accurate and reliable results. These standards are developed and maintained by recognized national and international bodies such as the National Institute of Standards and Technology (NIST) in the United States or the International Organization for Standardization (ISO). Calibration standards can encompass various types of measurements, including temperature, pressure, length, mass, and electrical parameters.The Calibration Process:The calibration process involves comparing the measurements of an instrument with a known standard to determine any deviations or inaccuracies. Let's take a step-by-step look at how this process works:1. Selecting the Calibration Standard: The first step is to identify the appropriate calibration standard that matches the measurement range and precision required. For example, if calibrating a thermometer, a certified reference temperature probe will be needed.2. Preparing the Instrument: Before calibration, the instrument isusually cleaned, inspected for physical damage, and, if necessary, adjusted to ensure it is in proper working condition.3. Performing the Calibration: The measurement readings of the instrument are compared with those of the calibration standard. The comparison may involve multiple measurements at different points to account for variations or inconsistencies.4. Calculating the Deviation: The deviation between the instrument's measurements and the calibration standard is calculated, typically in terms of the error or difference from the reference standard.5. Adjusting the Instrument: If the deviation is within an acceptable range, the instrument may require adjustment to align its measurements with the calibration standard. This adjustment is carried out by trained technicians or engineers using specialized tools or software.6. Issuing the Calibration Certificate: After the calibration process is complete, a calibration certificate is generated. This document provides details of the instrument, the calibration standard used,the deviations found, and any adjustments made. The certificate serves as evidence of traceability and compliance with quality standards.Importance of Calibration Standards:Calibration standards play a crucial role in ensuring the reliability and accuracy of measurements across various fields. Here are some key reasons why calibration standards are important:1. Quality Control: Calibration standards enable organizations to maintain consistent quality by ensuring that their measurement processes are accurate and precise. This helps to produce reliable products or services and minimize costly errors or rework.2. Compliance and accreditation: Many industries, such as pharmaceuticals, healthcare, and automotive, have strict regulatory requirements and quality assurance standards. Calibration standards enable organizations to meet these standards and gain accreditations such as ISO 9001 or ISO/IEC 17025.3. Scientific Research: In scientific research, even the tiniestmeasurement error can lead to erroneous conclusions. Calibration standards enable researchers to gather accurate and reproducible data, enhancing the credibility of their findings.4. Equipment Maintenance: Regular calibration ensures that measurement instruments are maintained and remain within specified tolerances. It helps detect any potential failures or discrepancies early, allowing for timely repairs or replacements, thus avoiding costly downtime.Conclusion:Calibration standards are indispensable tools that help maintain the accuracy and reliability of measurement instruments across various industries. By comparing measurements with known reference standards, calibration ensures that measurements are accurate, precise, and in compliance with regulatory requirements. Whether it's manufacturing, scientific research, or healthcare, calibration standards are key to achieving high-quality results and maintaining quality control. Through adherence to calibrationstandards, organizations can optimize their processes, enhance customer satisfaction, and ensure the integrity of their measurements.。
钢琴调律软件Tunelab4.0forPC使用介绍
钢琴调律软件Tunelab4.0forPC使⽤介绍⾃⼰动⼿调律!调律软件Tunelab使⽤介绍钢琴⾃产⽣之初就注定了它的不完美,律制,⾳准等等,但它仍然是不折不扣的乐器之王。
喜欢钢琴的朋友,特别是对于钢琴调律稍有了解的朋友,会经常对⾃⼰钢琴的声⾳不满意——刚调过时间不长,⼜觉得有⼀点稍稍不准了。
于是想⾃⼰动⼿调⼀下,但是⼜没有经过钢琴调律的专业培训,会不会出什么问题呢?我的看法,只要有动⼿能⼒,再加上好的乐感,使⽤Tunelab软件来辅助,没有经验的朋友⾃⼰尝试调⼀下钢琴还是可⾏的。
(当然,如果出现什么意外,我可不负责任的)。
这个软件本⼈已使⽤过相当⼀段时间,不错。
英⽂好的朋友,查看⼀下软件的帮助⽂件,应该基本可掌握基本的操作⽅法. 英⽂不好的朋友,可参考下⾯的汉英版(译者⽔平有限,基本能够表述原⽂的含义)Using this tutorial 如何使⽤此指南This tutorial is meant to be used as a step‐by‐step guide to certain operations in TuneLab Pro. 本指南将⼀步⼀步的指导您在TuneLab Pro中的操作. Many of these operations involve the keyboard.有相当⼀部分操作涉及到键盘的使⽤。
However, the keys that you press when this tutorial is displayed do not always go to TuneLab Pro.然⽽,当此帮助页⾯显⽰时,您按下键盘键并不总是能够回到TuneLab Pro操作界⾯。
In fact, every time you call this tutorial and every time you click in it, the tutorial acquires the "focus" of the keyboard.实际上,每当您查看本指南或者在本指南显⽰的区域内操作⿏标时,焦点总是被当前的指南页⾯获得的。
检验室执行定量检验的校正与校正验证
External Quality Control /Assurance
• ISO15189-5.6(Assuring quality of examination procedures) • 5.6.4實驗室應參加例如外部品質評鑑計畫所組織的 實驗室間比對。 • 實驗室管理階層應監控外部品質評鑑結果,並在當 無法滿足管制準則時,參與矯正措施之實行。 • 參與之實驗室間比對方案應在實質上符合ISO17043 之要求。 • 外部的品質評鑑方案須儘可能地提供臨床上相關的 挑戰,包括模擬病人的檢體與有效查核整個檢驗過 程,也要顧及檢驗前與檢驗後之流程。
為何需要執行校正?
• ISO15189-5.3(Laboratory equipment) • 5.3.2設備應在安裝或例行操作時,能顯示達到 所需的性能,並應符合相關之檢驗規格。實驗 室管理階層應建立一套方案,用以定期監控與 證明儀器、試劑及分析系統處於適當的校正狀 態與功能;且至少應採用製造商的建議訂有一 套書面化的預防維修方案與紀錄。當有製造商 的使用說明書、操作手冊或是其他的文件可利 用時,這些資料可用來建立符合相關標準或定 期校正的具體要求。
defined by Wen-Shyang Hsieh
校正的意義、方法、結果
Calibration Reports (pass or fail)
• Detective results PASS (accuracy) In Range • Back to Back (B/B) PASS (precession) ≤k • SPAN PASS (activity) ≥h
External Quality Control /Assurance
• ISO15189-5.6(Assuring quality of examination procedures) • 5.6.5當沒有正式實驗室間比對方案可利用時, 實驗室應發展一套機制以決定該程序的可接受 度。 • 當可能時,此機制應儘可能利用取自外部的且 具挑戰性之檢驗物質,例如與其他實驗室交換 檢體的方式。 • 實驗室管理階層應監控此類實驗室間比對機制 的結果,並參與矯正措施的實行與保有紀錄。
温度检测外文资料
Method for Effective Calibration of T emperature Loggers with Automated Data Sampling and EvaluationS. Ljungblad·L. E. Josefson·M. Holmsten1 IntroductionData loggers, such as Gemini Data loggers, are an easy-to-use and cheap method for recording data over time. The data loggers are used to monitor different parameters in many different areas such as the healthcare industry, the food industry, logistics, meteorology, and the environment . The loggers are normally programmed via some software to record at a certain frequency and placed at the spot where the data acquisition is going to take place. The logged data are first received when the logger is connected to the computer again. This feature makes calibration of data loggers time-and cost-consuming. Connolly presented an automated calibration procedure for industrial platinum resistance thermometers. Another example of an automated calibration procedure but for thermocouples and with wireless communication is presented by Y ang .The objective of the project is to develop an automated method that makes the calibration of data loggers more time- and cost-efficient. This method has been developed for temperature loggers from Gemini Data loggers, but the software could be adapted to suit other types of loggers as well.To suit the needs of the many different application areas, there are of course loggers with various capabilities when it comes to temperature measurements. However, the loggers from Gemini Data Loggers are all compatible with EasyView, the software provided by the manufacturer and commonly used to communicate with loggers of this make. However, this software can only be used to download and present the data from the loggers, not process the data. The evaluation needed of the data received from EasyView is quite straightforward but time-consuming. The main reason for this project has been to automate the calibration and evaluation process, so that it would be less time-consuming and hence more cost-efficient. The calibration software developed by SP, SPTempLogger, controls the communication with the loggers through EasyView, and thus the communication protocol ofthe logger software does not need to be known. But, in addition to this, SPTempLogger also evaluates the downloaded data.Most of the temperature loggers that we calibrate have an internal NTC thermistor.There are also loggers with external probes with either a thermistor or a Pt100 or Pt1000 sensor.2 Laboratory Equipment and Calibration ProcedureWhen the data loggers are received in the temperature laboratory, they are each assignedan individual calibration number. Details abouteach logger such as themodel, serial number, markings, or external probes are registered.When the loggers are to be calibrated, they are first connected to a jack panel,a commercial eight-channel USB-to-serial converter. In this jack panel, up to eight loggers can be connected at the same time. In addition, two loggers can be directly connected to the computer, i.e., ten loggers can be connected at the same time. The SPTempLogger software is then started and scans for connected loggers. The loggers are started individually, and calibration temperatures are selected and saved for each logger in a text file. This part is only partly automated as the appropriate settings of each logger may be different depending on both the calibration requested and the logger itself. The calibration temperatures requested also need to be specified.The loggers are then disconnected and the whole loggers, if there are no external probes, are placed in calibration baths properly protected from the bath liquid. The method of protection differs depending on the model. For the most common models,metallic tubes that the loggers fit into with a minimum of air inside are used. The base of the tube is welded shut and has a support so that the loggers do not rest on the bottom of the bath. On top of the loggers inside the tube is Styrofoam to isolate the logger from the environment outside the bath. The other method of protection for loggers of different shapes and sizes is to protect them with a thin plastic film, usually two layers to prevent leakage. The first method requires much less time to set up, butthe loggers will need longer time in the liquid bath to stabilize. When the two methods were compared, the same results were achieved with both.The amount of loggers that can be calibrated simultaneously depends on the liquid baths and the logger model. If too many loggers are put in the bath at the same time,the temperature distribution within the bath might be disturbed. We primarily use two commercial calibration baths with a stability better than 0.01 ℃. Both of these calibrationbaths have a large opening and are suitable for calibrating up to 12 loggers at the same time. The first is a Hart Scientific Model 7037 bath which is used with ethanol as the working fluid between -35 ℃and 15 ℃. The second bath is a Heto Model KB 24 used with water between 15 ℃and 80 ℃. For temperatures below -35 ℃and above 80 ℃, we use calibration baths with smaller openings and thus cannot calibrate more than a few loggers at once. We have a range of calibration baths from -100 ℃to 550 ℃from Heto, Hart Scientific, and our own brand.The reference temperature in the baths is measured with a calibrated digital thermometer (Hart Scientific Model 1502A) with a Pt100 sensor. The instrument transmits the measured temperature by way of Bluetooth to a computer which saves the temperatures and the time of measurements in a file. Other types of communication such as RS-232 and USB may be used as well, depending on the reference instrument. The reference temperature is also displayed graphically on the screen so one can easily seewhether the temperature in the bath is stable or not, and for how long it has been so.The loggers are left in the liquid bath after the temperature has stabilized for at least an hour and a half, if the logger has an internal sensor. Through experimentation,this has been determined to be enough time for the temperature to stabilize inside the logger. Loggers with external sensors require less time to stabilize. A calibration usually consists of two or more temperatures, and thus the temperature of the bath may need to be changed when the first calibration temperature is completed, or the loggers and reference thermometer moved to a different bath.When the calibration is completed, the loggers are extracted from the bath and thereference temperature logging stopped. The loggers are then connected to the jack panel again and the SPTempLogger software started. The software downloads the temperature measurement data from the first logger. It then proceeds to evaluate these results compared to the corresponding reference temperature file. When a resulting mean value for each calibration temperature has been calculated, it continues with the next logger in turn.When all loggers connected to the jack panel have been evaluated, the results are displayed in a table and can be saved directly to a database from which the calibration certificate is produced.3 MeasurementsFigure 1 presents a graph of a calibration with both the reference and logger temperature.This is a calibration in three temperatures, and though each logger is evaluated separately, a number of loggers can be calibrated in the same bath at the same time,using the same reference data.As seen in Fig. 1, the reference thermometer has a faster response time than theFig. 1 Logger calibration temperatures4 Evaluation of Logger DataThe procedure for evaluation of logger data has been chosen both because it delivers reliable and accurate results and because it is time efficient. A similar, but more advanced evaluation algorithm is described by Wilhelm et al.The evaluation algorithm first calculates a preliminary mean reference temperature for each calibration temperature of the logger in question. The calibration temperature is the nominal temperature, e.g,-25 ℃, and the reference temperature is the actual measured temperature in the bath, e.g,-24.975 ℃. To find this preliminary mean reference temperature, an algorithm searches through the reference temperature data for a temperature plateau. 95% of the reference temperatures within a 15 min period should be within±2 ℃of the calibration temperature. In addition to this, the standard deviation of the reference data inthat interval should be below a specified value. The chosen limit value for the standard deviation depends on the reference thermometer used, and also on the stability of the calibration bath used. Through experimentation we have determined that the values in table 1 for the standard deviation are suitable for our facility. When an interval that meets the criteria has been found, its start and stop times are registered. The result of this is that we have a time interval when the temperature in the calibration bath was stable close to the calibration temperature.Table 1 Limit values for the standard deviation of the reference temperature for a plateau interval Calibration temperature (℃)Standard deviation (℃)<30 0.00130-50 0.005>50 0.01The program then tests the next interval by setting a start time one measurement later and evaluating it against the same criteria. The last 15 min interval found that meet the criteria will be the one selected. The mean temperature of this interval is set as a preliminary reference temperature. Figure 2 shows the selection of the last 15 min interval for the -25 ℃plateau.After this, the logger data are evaluated. The algorithm searches through the logger data looking for a 15 min interval that has confidence level of 95%and is previous to the stop time of the determined reference temperature plateau. That means in this case that 95%of the values within the 15 min interval are within ±1 ℃℃from the calculated preliminary mean reference temperature. The resulting interval will be the last one in the data that meets both criteria. Figure 3 shows the selected 15 min interval for the一25 ℃plateau. The algorithm will have found the logger data for the last 15 min of the temperature plateau, before the temperature in the bath is changed or the loggers extracted from the bath.An algorithm then scales the chosen interval from 15min to lOmin. This is to make sure that the resulting interval is not affected by any errors that may occur if the reference thermometer is removed from the calibration bath before the loggers. If the difference between the mean logger temperature of the 15 min interval and the first value of the 15 min interval is larger than the difference between the mean logger.temperature and the last value of the interval, the first value would be discarded. This procedure is repeated until the interval left is 10 min long. If the temperature is stable for the whole interval, the same amount of values will be discarded from each end.The mean temperature, resolution, and standard deviation of the logger are calcufated for this 10 min interval. The algorithm then searches through the logged reference temperature data, and finds the corresponding time interval and calculates a mean reference temperature for those l0min.T able 2 Results for calibration at −25 ℃Temperature(℃)Resolution(℃)Standard deviation Reference -24.9747 0.001 0.00069Logger -24.990 0.003 0The result for the calibration at -25℃in our example is shown in Table 2. These results are displayed in a table at the end of the evaluation process, but one can also choose to have a diagram displayed on the screen or printed. This provides a quick way to check that the software has been able to choose the correct time interval to evaluate. A diagram of the entire calibration like the one in Fig. 1 is also printed to get a quick overview and see that the logger has had sufficient time to stabilize.5 ResultsThe result of the evaluation is a mean temperature for each calibration temperature and logger, and a corresponding mean reference temperature based on the same time interval as the logger's mean temperature.In addition to this, we also know the resolution for each logger at the cali bration temperatures, as well as the standard deviation of the logger data. These results, together with data for the calibration equipment, etc., are used to calculate the measurement uncertainty associated with each calibration. The calibration baths have temperature gradients present in the bath, and in addition, the loggers disturb the circulation in the bath. By careful systematic measurement at different places in the bath with a SPRT,the uncertainty contribution from temperature gradients in the bath is estimated to 0.021℃.。
calibration
calibration1.为什么要校准,意义何在?原因:是⽆线设备所⽤的元器件的绝对精度不够,通常不能满⾜设备频率、功率电平和其他参数的性能指标,同时在组装完成后,元器件以及⼯艺流程、作业⼿法本⾝存在的误差,使得每台⽆线设备的电⽓性能不相同,这可能会对⽆线设备的通信质量产⽣较⼤的影响,同时在批量⽣产阶段,不良率会很⾼,造成定位困难。
意义:校准可以减少⽆线发射、接收设备对元器件的要求,降低材料成本,最终降低整个⽆线发射、接收设备的成本使通信质量达到最佳;2.校准的原理和算法是什么样的?在成产测试过程中,通过计算机控制⽆线设备进⼊测试状态,并通过仪器仪表测量⽆线设备的相关参数,对需要补偿校准的数据测量计算并存储到EEPROM。
校准简单的原理就是:由于器件不⼀致,温度变化,器件⽼化等因素的影响,即使是基于同样的平台,同样的设计,也会表现出不同的电性能。
为了消除这种影响,每个⽆线设备在出⼚之前都要对这些参数进⾏测量计算得到⼀些参数误差数据,并把这些误差数据存储到⼀定的存储介质(⼀般在EEPROM)⾥,在⽆线设备正常使⽤的过程中,CPU 会去这些数据并利⽤⼀定的算法对需要补偿的参数进⾏补偿。
3.校准的流程1.通过计算机将⽆线设备控制为测试模式,2.配置各种测试仪器,形成校准的⽆线环境;3.计算机控制仪器和⽆线设备,使之进⼊要求的状态;4.让仪器或者⽆线设备发射⽆线信号;5.让⽆线设备或者仪器进⾏测量,并读取测量值;6.基于测量值进⾏计算,得到某项指标的校准结果;7.将测量的结果写⼊⽆线设备的EEPROM;4.CAL的硬件的结构1.计算机(PC):控制⽆线设备,执⾏校准过程;2.综测仪:给⽆线设备提供各种测试环境,测量⽆线设备发出的信号功率、频率等,在cal的过程中,综测仪作为信号发⽣器和功率计,它需要通过GPIB卡与PC相连接,以便受PC控制,⽆线设备通过射频线连接;3.稳压电源:给⽆线设备提供各种电压,并在电池电压校准时,测量⽆线设备发出的的电压以及电流值;4.GPIB卡:为校准提供控制线路;即PC控制⽆线设备和仪器的控制线;5.⽆线设备:CAL就是校准⽆线设备的的各项参数,它通过Com⼝与PC相连接,受PC控制,并通过射频线与测试仪器相连接;6.屏蔽箱:给⽆线设备提供纯净⽆⼲扰的环境;7.治具:根据⾃⼰的产品做相应的治具平台(BT 时,采⽤RF探针,FT时,⽤天线耦合);5.软件这个软件是在PC端运⾏的程序,主要控制仪器和⽆线设备,包括串⼝控制,GPIB接⼝控制,EMMI协议,CAL的算法,以及程序外观接⼝;6.⽆线设备校准测试的项⽬内容有哪些?1.电池的校准以及其他的⼀些校准,如温度校准、直流偏执校准等等,都是对基带参考电路中的A/D参考电压的⼀个校准,以保证A/D读数的准确性。
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ABSTRACT This paper describes a W-band (75-110 GHz) onwafer probing calibration procedure based on the microstrip SOLT calibration technique. Two onwafer offset-open microstrips are used together with SOLT standards to generate high frequency calibration kits. For microstrip-line calibration on 2-mil thick GaAs substrate, measurements of some passive elements are presented and compared with those measured by a multiline TRL calibration. Electromagnetic simulations of these calibration and test standards are also generated. Close agreement between measurements and computer simulation provides verification in high frequency range (75-1 10 GHz). Measurements using this calibration kit from 1 to 65 GHz are also checked against previously reported data [2]. It is found that this SOLT calibration standard set is valid from 1 to 110 GHz. INTRODUCTION With MMIC applications moving into Wband (75-110 GHz) and higher, accurate onwafer testing at millimeter-waves is becoming more important in device and circuit characterization[l]. Recently, DuFault and Sharma reported a novel procedure [2] to enhance the accuracy of SOLT calibration up to 75 GHz, where an on-wafer multiline TRL calibration [3] is developed to measure the SOLT calibration standards and provide verification for SOLT measurement data. However, for microstrip-line calibartion upto W-band and higher, the accuracy of the equivalent model for the LOAD standard in SOLT calibration kit remains questionable. The calibration errors can be clearly displayed when checked against some offset-open lines. This is basically due to a limitation of the lumped-element model adopted by the SOLT calibration. Even with TRL calibra0-7803-3814-6/97/$5.00 0 E E E
MODIFICATION ON THE EXISTING (1-65 G H ~ sow ) CALIBRATION For S-parameter measurements, the short, open, load and through (SOLT) calibration requires precise knowledge of the s-parameter of four standards. As the equivalent circuit models adopted in SOLT are defined in a given topology, the distributive characteristics of the LOAD standard has long been a difficult element to model in terms of ideal lumped-elements. Such a discrepancy become imore and more severe when measurements are done in W-band and higher. Our updated SOLT calibration procedure
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A Calibration Procedure for W-band On-wafer Testing
Yon-Lin Kok, Mark DuFault, Tian-Wei Huang and Huei Piang TRW Space and Electronics Group One Space Park Redondo Beach, CA 90278
MEASUREMENTS OF PASSIVE ELEMENTS Figure 2 and 3 shows a comparison between measurements done with SOLT and TRL calibration methods for the OPEN and the LOAD calibration standards. Sonnet [4] electromagnetic simulation results are also shown. Although electromagnetic coupling effects are detectable on TRL measurement of the OPEN standard at 94 GHz, its phase measurements matches well with EM simulation. For the LOAD standard, the SOLT calibration kit is updated such that the phase values of the measurement follow the trend predicted by TRL cal0
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1997 IEEE MlT-S Digesi
account for errors generated in such a situation. The SOLT standards model derived by Dufault and Sharma [2] is adopted initially to measure two offset-open lines in 75-110 GHz frequency range. Given the knowledge that the reflection coefficient should be of unit amplitude in an ideally lossless case, we are able to modify the SOLT standard models such that they generate the desired, unit amplitude offset-open measurements. By only adjusting the line length of the microstrip line associated with the LOAD model, we successfully generate unit-amplitude reflection coefficients. Figure 1 shows high frequency measurements done by two different calibration kits and electromagnetic simulation for the 255 pm offset-open line. Large deviation or correction is found between the existing and the updated calibration kits. Agreement between EM-simulation and the updated calibration kit supports the accuracy of the phase value in measurements.
tion where the LOAD standard is not needed, electromagnetic coupling between the long lines and their adjacent circuitries has introduced another difficulty in W-band calibration. In this paper we propose to use measurements of two additional microstrip offset-open lines, 255 pm and 102.5 pm long, to correct the errors made in the existing SOLT standard models, in particular the LOAD model for high frequency (75-1 10 GHz) measurements. An updated SOLT calibration kit is then formulated. TRL results are adso generated as supporting data although some coupling effects at Wband are detectable. Close agreement on the SOLT standard measurements and some radial stubs measurements are: obtained. They are compared with electromagnetic simulated data throughout the whole frequency spectrum from 1 to 110 GHz. Accuracy of the calibration procedure is ducumented for microstrip lines on 2-mil thick gallium arsenide >' b strate.