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ballesteros-weinstein编码规则 -回复

ballesteros-weinstein编码规则-回复1. 什么是[ ballesterosweinstein编码规则]?Ballesterosweinstein编码规则是一种用于数字数据压缩和解压缩的编码规则。

该编码规则由Xavier Ballesteros和Ronald Weinstein于1999年提出，并在许多领域得到了广泛应用，如通信、图像处理和存储等。

2. 为什么需要数字数据压缩?数字数据的存储和传输需要占用大量的存储空间和带宽。

为了节省存储空间和提高数据传输效率，需要对数字数据进行压缩。

数字数据压缩可以将数据表示为更紧凑的形式，从而减少存储空间和传输时间。

3. Ballesterosweinstein编码规则的基本原理是什么？Ballesterosweinstein编码规则基于一种称为波峰波谷编码的概念。

该编码规则通过将数字数据表示为波峰和波谷的序列来压缩数据。

波峰表示数据中较大的值，而波谷表示较小的值。

4. Ballesterosweinstein编码规则的编码步骤是什么？编码步骤如下：- 首先，将数字数据分成多个区域。

这些区域可以基于像素、时间或其他特征进行定义。

- 对于每个区域，找到最高和最低的数字值，分别作为波峰和波谷。

然后，将该区域内的其他数字值与波峰和波谷进行比较，并按照其相对位置进行编码。

较大的值表示为'+'，较小的值表示为'-'。

- 将所有区域的编码连接在一起，形成最终的编码字符串。

5. Ballesterosweinstein编码规则的解码步骤是什么？解码步骤如下：- 首先，将编码字符串按区域分割，并提取出波峰和波谷的位置。

- 对于每个区域，依据波峰和波谷的位置，将'+'替换为较大的值，将'-'替换为较小的值。

- 将所有区域的数字值连接在一起，得到原始的数字数据。

6. Ballesterosweinstein编码规则的优缺点是什么？优点：- Ballesterosweinstein编码规则简单且易于实现。

康复龙.康力龙.群勃龙报价单模板(中英文)

序号
生产厂家-武汉欣欣佳丽生物科技有限公司报价品名（Product Name）
1
2 3 4 5 6 7 8 9
备注（Remarks）
供应商（Supplier）
康复龙Oxymetholoe 群勃龙Trenbolone 替勃龙Tibolone 群勃龙庚酸酯trenbolone enanthate 屈他雄酮丙酸酯Drostanolone Propionate 康力龙stanozolol 苯丙酸睾酮Testosterone phenylpropionate 米勃龙群勃龙醋酸酯Trenbolone Acetate
≥99.0%
数量（Quantity）
价格（Price）
NXINJIALI BIO-TECH CO.,LTD.）
opment Zone No. 118,HuBei Prov., China.
丽生物科技有限公司报价单（Quotation）
CAS编号(CAS NO.)
质量规格 161-33-8 5630-53-5 2322-77-2 521-17-5 10418-03-8 1255-49-8
10161-34-9
≥98.0%
≥98.0% ≥99.0% ≥99.0% ≥99.0% ≥99.0% ≥99.0%
生产厂家武汉欣欣佳丽生物科技有限公司报价单quotation品名productnamecas编号cas质量规格specifcations数量quantity价格price康复龙oxymetholoe群勃龙trenbolone替勃龙tibolone群勃龙庚酸酯trenboloneenanthate屈他雄酮丙酸酯drostanolonepropionate康力龙stanozolol苯丙酸睾酮testosteronephenylpropionate群勃龙醋酸酯trenboloneacetate10161349备注remarks供应商supplier武汉欣欣佳丽生物科技有限公司wuhanxinxinjialibiotechco

WHO_TRS_996_annex09翻译

Annex9组织机构进行体内生物等效性研究指南背景2014年的一场非正式讨论会上，在世界卫生组织（WHO）药学准备工作规范专家委员会的第49次会议，讨论产生关于可能修正组织机构进行体内生物等效性研究指南（WHO技术报告系列，No. 937, Annex9, 2006）。

WHO药学准备工作规范专家委员会同意，鉴于新的事态发展，将会准备一条修正法案。

新的指南不仅考虑多来源指南的修订，并会考虑创造良好数据管理下的新的指南。

法案也会考虑自从2006年评价和稽查BE试验领域的经验。

在稽查者们重复发现相同问题的领域，新的指南将会提供阐述，增补的细节也已加入生物分析。

指南也会更加注重项目安全性和数据完整性。

在第一版工作文件的基础上，第二版结合了很多的意见和反馈，有来自于公众、WHO资格预审团队(PQT)的意见，也有来自于2015年举行的关于数据管理、生物等效性、GMP、药品稽查的讨论会。

WHO/PQT建立于2001年，是为了保障采购的药用产品满足WHO关于质量、安全性、有效性的规范和标准(http://www.who.int/prequal/)。

特别的是，要求报送的产品档案所有必要的内容经评估都是可接受的，成品药（FPP）以及API的生产地点满足WHO的GMP要求。

由于报送WHO/PQT的产品通常是多来源的（仿制的），一般通过在比如合同研究组织CRO（也叫做临床研究机构）进行的BE试验来证明治疗等价性。

对于资格预审的产品至关重要的是，除了上述的要求，申办方BE试验使用的CRO公司要满足WHO的药物临床试验质量管理规范GCP，考虑优良实验室规范GLP和质量控制（QC）305实验室管理规范来保证数据的完整性和可追溯性。

除此之外，如果存在当地的法律法规，CRO应该得到各自国家药品局的认可。

如果国家规定需要，BE试验应该获得国家监督管理局的授权。

因此报送资格预审的产品涉及到BE试验中执行和分析的，需要保证满足WHO相关的规范和标准，以便为WHO的稽查做准备。

(2024年详解)国家慢性疾病编码指南英文版

(2024年详解)国家慢性疾病编码指南英文版(2024 Explained) National Chronic Disease Coding GuidelinesIn 2024, the National Chronic Disease Coding Guidelines were introduced to provide a standardized system for classifying and coding chronic diseases. These guidelines aim to streamline the process of recording and categorizing chronic health conditions, making it easierfor healthcare providers to track and manage patient information effectively.Chronic diseases, such as diabetes, heart disease, and cancer, are long-lasting conditions that require ongoing medical attention. By following the National Chronic Disease Coding Guidelines, healthcare professionals can accurately document these conditions in medical records, ensuring that patients receive the appropriate care and treatment.The coding guidelines include a comprehensive list of codes for different chronic diseases, each corresponding to a specific diagnosis. These codes help healthcare providers accurately identify and classify a patient's condition, enabling them to provide tailored treatment plans and monitor the progression of the disease over time.In addition to standardizing the coding process, the National Chronic Disease Coding Guidelines also promote consistency and accuracy in healthcare documentation. By using the prescribed codes, healthcare providers can communicate effectively with other professionals, insurance companies, and government agencies, ensuring that all relevant parties have access to the necessary information.Overall, the National Chronic Disease Coding Guidelines play a crucial role in improving the quality of care for patients with chronic conditions. By adhering to these guidelines, healthcare providers can better manage and monitor chronic diseases, ultimately leading to better health outcomes for individuals with long-term health issues.。

国家药品供应保障综合管理信息平台YPID编码规则与应用

doi:10.3969/j.issn. 1672-5166.2019.02.06国家药品供应保障综合管理信息平台YPID编码规则与应用钱军程①⋯胡建平①△文章编号：1672-5166（2019)02-0148-04 中图分类号：R-34 ；R918-39 文献标志码：A摘要省级药品集中采购是新一轮深化医药卫生体制改革的重要举措，省级药品集中采购平台是实现药品政策改革目标的重要抓手，实现国家药品供应保障综合管理信息平台与省级药品集中采购平台的互联互通，是收集全国各省药品集中采购信息的重要手段。

药品标识码YPID是药品的唯一性编码，是确保药品可识别、价格可比较的重要依据，是对药品开展信息化管理的重要基石。

本文对国家药管平台药品唯一性标识码YPID 的背景、编码规则及应用作详细介绍。

关键词药品编码国家药管平台药品集中采购The Coding Rule and Application of Unique Identification Drug Code (YPID)on China Drug Supply Information PlatformQIAN Juncheng, HU JianpingCenter for Health Statistics and Information, National Health Commission of the P.R.China, Beijing 100810, China Abstract Provincial centralized drug purchasing is an important step in the deepening of health system reform. The provincial centralized drug purchasing platform is an effective measure to help implement the drug reform policy in China. The interconnection between China Drug Supply Information Platform(CDSIP) and provincial centralized drug purchasing platforms was a key method to collect information on drug transactions. The Drug Identification Code (YPID) is an unique identity of drug, which is a crucial basis for computer to identify and analyze drug information. This article introduces the background, coding rule, and the application of YPID in detail.Key words drug code; China drug supply information platform; centralized purchasing of drugs0 引言2009年，我国启动了新一轮医药卫生体制改革。

药品生产验证指南2003版英文翻译

Drug Production Validation Guidelines 2003 Edition - EnglishTranslationIntroductionThe Drug Production Validation Guidelines were first published in 2003 to provide a comprehensive framework and set of recommendations for validating pharmaceutical manufacturing processes. This document presents an English translation of the guidelines, which aim to ensure the safety, quality, and efficacy of pharmaceutical products.ScopeThe Drug Production Validation Guidelines apply to all stages of the drug manufacturing process, including the production of active pharmaceutical ingredients (APIs) and finished dosage forms. The guidelines provide direction for both new drug products and existing ones that undergo changes in their manufacturing processes.Purpose of ValidationThe primary purpose of drug production validation is to demonstrate that the manufacturing processes consistently produce pharmaceutical products that meet the predetermined quality attributes, ensuring their safety and efficacy. Validation also helps in identifying and controlling potential sources of variability that may affect the quality of the products.General Principles1. Process DesignThe guidelines emphasize the importance of robust process design, which involves defining critical process parameters and establishing appropriate control strategies. Process design should consider factors such as quality, safety, efficiency, and regulatory requirements.2. Process QualificationProcess qualification involves confirming the suitability and capability of the manufacturing process through a series of documented tests, studies, and evaluations. Three stages of process qualification are identified: installation qualification, operational qualification, and performance qualification.3. Continued Process VerificationOnce a process is qualified, continued process verification is necessary to ensure that the manufacturing process remains in a state of control. This involves ongoing monitoring, analysis of process data, and periodic re-evaluation to identify and address any potential sources of variability or process deviations.Validation Master Plan1. PurposeThe Validation Master Plan (VMP) provides an overview of the entire validation process and establishes the validation strategy for the drug manufacturing facility. It outlines key activities, responsibilities, and timelines for validation activities.2. ContentsThe VMP should include the following sections: - Introduction and scope - Validation policy and objectives - Roles and responsibilities - Validation activities and schedules - Change control procedures - Documentation requirements - Validation protocols and reports - Deviation management - Training requirements Validation Documentation1. Validation ProtocolsValidation protocols are detailed documents that outline the series of tests, experiments, and observations to be performed during the qualification and validation processes. They should describe the acceptance criteria, sampling plan, and test methods.2. Validation ReportsValidation reports summarize the results obtained during the qualification and validation activities. They should include a description of the tests performed, data analysis, conclusions, and any deviations or discrepancies identified.3. Change ControlChange control procedures should be in place to manage any changes to the validated manufacturing processes. The guidelines recommend that any proposed changes be evaluated for potential impact on product quality and documented in change control records.ConclusionThe Drug Production Validation Guidelines provide a robust framework for ensuring the safety, quality, and efficacy of pharmaceutical products through the validation of manufacturing processes. By following these guidelines, drugmanufacturers can mitigate risks, control variability, and produce high-quality pharmaceuticals. It is essential for pharmaceutical companies to adopt and adhere to these guidelines to comply with regulatory requirements and ensure patient safety.。

sample_references

AEA Publications Sample ReferencesWe use the Chicago Manual of Style Author-Date system for all common publication types:/16/ch15/ch15_sec009.html.The following examples are intended to provide information for less common sources.DatasetsWhen referencing datasets, please include the author name or name of the provider hosting the data, the year the data were collected or posted, the name or title of the dataset, the name of the database if applicable, and any other information necessary for one to retrieve the data. Please include the date accessed in parentheses at the end. Example 1: Bureau of Labor Statistics. 2000–2010. “Current Employment Statistics: Colorado, Total Nonfarm, Seasonally adjusted - SMS08000000000000001.” United States Department of Labor. /cgi-bin/surveymost?sm+08 (accessed February 9, 2011).Example 2:Leiss, Amelia. 1999. “Arms Transfers to Developing Countries, 1945–1968.” Inter-University Consortium for Political and Social Research, Ann Arbor, MI. ICPSR05404-v1. doi:10.3886/ICPSR05404 (accessed February 8, 2011).For data references specifically associated with a published paper, please include the Author Name(s). Year. “Paper Title: Dataset.” Journal Name. Location of the data.Example 3: Romer, Christina D., and David H. Romer. 2010. “The Macroeconomic Effects of Tax Changes: Estimates Based on a New Measure of Fiscal Shocks: Dataset.” American Economic Review./articles.php?doi=10.1257/aer.100.3.763 (accessed August 22, 2012).Multivolume WorksMultivolume works include works such as encyclopedias, multivolume works published over several years, and multivolume works published in a single year. Below are a few examples.Example 1: Kohama, Hirohisa, ed. 2003. Asian Development Experience. Volume 1. External Factors in Asian Development. Singapore: Institute of Southeast Asian Studies.Example 2: Kusuoka, Shigeo, and Akira Yamazaki, ed. 2006. Advances in Mathematical Economics. Volume 8. New York: Springer.Example 3: Mokyr, Joel, ed. 2003. The Oxford Encyclopedia of Economic History. 5 vols. Oxford: Oxford University Press.Working PapersOnly papers appearing as part of an institution’s working papers series should be classified as working papers. These should always include a specific working paper number as assigned by the institution.Author Last Name, First Name. Year. “Title.” Type of Working Paper (such as institution, working series title) and number.Example 1: Ausubel, Lawrence M. 1997. “An Efficient Ascending-Bid Auction for Multiple Objects.” Universityof Maryland Faculty Working Paper 97–06.Example 2: Heidhues, Paul, and Botond Kőszegi. 2005. “The Impact of Consumer Loss Aversion on Pricing.” Centre for Economic Policy Research Discussion Paper 4849.Unpublished PapersWhen a paper has not been published but can be found on the Web (such as the author’s website or the university website), use the following format: Author Last Name, First Name. Year. “Title.” URL. Please provide a URL that links to the full text of the article.Example 1: Zitzewitz, Eric. 2006. “How Widespread Was Late Trading in Mutual Funds?”/zitzewitz.When a paper has not been published and does not appear on a website (such as the author’s website or university website), use the following format: Author Last Name, First Name. Year. “Title.” Unpublished.Example 2: Acemoglu, Daron, Pol Atràs, and Elhanan Helpman. 2006. “Contracts and Technology Adoption.” Unpublished.Lectures and Papers Presented at MeetingsAuthor Last Name, First Name. Year. “Title.” Paper presented at followed by meeting name, place, and city where the lecture/meeting took place.Example 1: Romer, Christina D., and David H. Romer. 2006. “The Evolution of Economic Understanding and Postwar Stabilization Policy.” Paper presented at the Rethinking Stabilization Policy Federal Reserve Bank of Kansas Symposium, Jackson Hole, WY.Example 2: Goldin, Claudia. 2006. “The Quiet Revolution that Transformed Women’s Employment, Education, and Family.” Paper presented at the annual meeting of the Allied Social Science Associations, Boston. Newspapers, Online Encyclopedias, and Reference WorksBecause newspapers, magazines, and encyclopedias are continuously updated, they should be cited as footnotes in the text. They should not be included in the reference list. Undated sources should always include an access date along with the URL. When possible, use the URL assigned to the specific content you are citing.Author Last Name, First Name. Year. “Title.” Magazine, Month and Day. URL.Example: Becker, Gary S. 1993. “The Evidence against Blacks Doesn’t Prove Bias.” Business Week, April 19. /index.jsp.Books Published ElectronicallyIf a book is available in more than one format, cite the version you consulted. For books consulted online, list a URL. If no fixed page numbers are available, you can include a section title or a chapter or other number.Author Last Name, First Name. Year. Title. City: Publisher. Format.Example 1:Austen, Jane. 2007. Pride and Prejudice. New York: Penguin Classics. Kindle edition.Example 2:Kurland, Philip B., and Ralph Lerner, eds. 1987. The Founders’ Constitution. Chicago: University of Chicago Press. /founders/.。

Trodelvy产品说明书

Trodelvy® (sacituzumab govitecan‐hziy)(Intravenous)Document Number: MH‐0532 Last Review Date: 03/01/2022Date of Origin: 06/02/2020Dates Reviewed: 06/2020, 09/2020, 01/2021, 05/2021, 03/2022I.Length of AuthorizationCoverage will be provided for six months and may be renewed.II.Dosing LimitsA.Quantity Limit (max daily dose) [NDC Unit]:∙Trodelvy 180 mg single-dose vial:12 vials every 21 daysB.Max Units (per dose and over time) [HCPCS Unit]:∙432 billable units weekly for two doses every 21 daysIII.Initial Approval Criteria 1Coverage is provided in the following conditions:Submission of medical records (chart notes) related to the medical necessity criteriais REQUIRED on all requests for authorizations. Records will be reviewed at thetime of submission. Please provide documentation related to diagnosis, steptherapy, and clinical markers (i.e. genetic and mutational testing) supportinginitiation when applicable. Medical records may be submitted via direct uploadthrough the PA web portal or by fax.∙Patient at least 18 years of age; ANDUniversal Criteria 1∙Therapy will NOT be substituted for or used in combination with irinotecan; AND∙Patients that are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele will be closely monitored for adverse reactions; AND∙Therapy will not be used in combination with UGT1A1 inhibitors (e.g., nilotinib, regorafenib, etc.) or inducers (e.g., phenytoin, carbamazepine, etc.); AND∙Used as single agent therapy; ANDBreast Cancer † ‡ 1-3∙Patient has unequivocal triple-negative disease [TNBC] (i.e., estrogen, progesterone, and HER2-negative)*; AND∙Patient was previously treated with at least two systemic therapies, at least one of them for metastatic disease; ANDo Patient has recurrent unresectable, locally advanced, or metastatic disease; ORo Patient has inflammatory breast cancer with no response to preoperative systemic therapyUrothelial Cancer (Bladder Cancer)† ‡ 1,2,10∙Patient has one of the following diagnoses:o Locally advanced or metastatic urothelial carcinoma; ORo Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder ‡; ORo Metastatic or local bladder cancer recurrence post-cystectomy ‡; ORo Primary carcinoma of the urethra ‡; ANDUsed for recurrent (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes) or metastatic disease; ORo Metastatic upper genitourinary (GU) tract tumors ‡; ORo Metastatic urothelial carcinoma of the prostate ‡; AND∙Patient was previously treated with platinum-containing chemotherapy and programmed death (PD-1 or PD-L1)-directed therapy (e.g., avelumab, nivolumab, atezolizumab,durvalumab, etc.)† FDA approved indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug∙Immunohistochemistry (IHC) assay is 0 or 1+; OR∙Dual-probe in situ hybridization (ISH) assay indicating (Group 5) HER2/CEP17 ratio <2.0 AND average HER2 copy number <4.0 signals/cell; OR∙Concurrent dual-probe ISH and IHC assay results indicating one of the following: o(Group 2) HER2/CEP17 ratio ≥2.0 AND average HER2 copy number <4.0 signals/cell and concurrent IHC 0-1+ or 2+; ORo(Group 3) HER2/CEP17 ratio <2.0 AND average HER2 copy number ≥6.0 signals/cell and concurrent IHC 0-1+; ORo(Group 4) HER2/CEP17 ratio <2.0 AND average HER2 copy number ≥4.0 and <6.0 signals/cell and concurrent IHC 0-1+ or 2+9∙Immunohistochemistry (IHC) assay: Sample is considered ER/PR negative if the percentage of cancer cells staining on evaluation is <1% OR 0% of tumor cell nuclei are immunoreactiveNote: A sample may be deemed uninterpretable for ER or PR if the sample is inadequate(insufficient cancer or severe artifacts present, as determined at the discretion of thepathologist), if external and internal controls (if present) do not stain appropriately, or ifpre-analytic variables have interfered with the assay’s accuracy.IV.Renewal Criteria 1Coverage can be renewed based upon the following criteria:∙Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performancestatus, etc. identified in section III; AND∙Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND∙Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity and infusion-related reactions, severe nausea/vomiting, severeneutropenia/febrile neutropenia, severe anemia, severe diarrhea, etc.V.Dosage/Administration 1Breast Cancer/ Bladder Cancer Administer 10 mg/kg as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity. Do not administer doses greater than 10 mg/kg.VI.Billing Code/Availability InformationHCPCS Code:∙J9317 – Injection, sacituzumab govitecan-hziy, 2.5 mg; 1 billable unit = 2.5 mgNDC:∙Trodelvy 180 mg lyophilized powder in a single-dose vial: 55135-0132-xxVII.References1.Trodelvy [package insert]. Morris Plains, NJ; Immunomedics, Inc; October 2021. AccessedFebruary 2022.2.Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium®) sacituzumab govitecan. National Comprehensive Cancer Network, 2022.The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONALCOMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® aretrademarks owned by the National Comprehensive Cancer Network, Inc. To view the mostrecent and complete version of the Compendium, go online to . AccessedFebruary 2022.3.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology(NCCN Guidelines®) for Breast Cancer 2.2022. National Comprehensive Cancer Network, 2022. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCNGUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to .Accessed February 2022.4.Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and CytotoxicAnticancer Agents: A Position Statement of the Hematology/Oncology PharmacyAssociation. J Oncol Pract. 2018 Mar;14(3):e130-e136.5.Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste IssueBrief. Retrieved from /images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf6.Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials ofcancer drugs. BMJ. 2016 Feb 29;352:i788.7.Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in RefractoryMetastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi:10.1056/NEJMoa1814213.8.Wolff AC, Hammond EH, Allison KH, et al. Human epidermal growth factor receptor 2testing in breast cancer: American Society of Clinical Oncology/College of AmericanPathologists Clinical Practice Guideline Focused Update. J Clin Oncol 2018;36:2105-2122.9.Allison KH, Hammond EH, Dowsett M, et al. Estrogen and Progesterone Receptor Testingin Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol 38:1346-1366.10.Tagawa S, Balar A, Petrylak, et al. TROPHY-U-01: A Phase II Open-Label Study ofSacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma ProgressingAfter Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.Appendix 1 – Covered Diagnosis Codes1010C50.011 Malignant neoplasm of nipple and areola, right female breastC50.012 Malignant neoplasm of nipple and areola, left female breastC50.019 Malignant neoplasm of nipple and areola, unspecified female breastC50.021 Malignant neoplasm of nipple and areola, right male breastC50.022 Malignant neoplasm of nipple and areola, left male breastC50.029 Malignant neoplasm of nipple and areola, unspecified male breastC50.111 Malignant neoplasm of central portion of right female breastC50.112 Malignant neoplasm of central portion of left female breastC50.119 Malignant neoplasm of central portion of unspecified female breastC50.121 Malignant neoplasm of central portion of right male breastC50.122 Malignant neoplasm of central portion of left male breastC50.129 Malignant neoplasm of central portion of unspecified male breastC50.211 Malignant neoplasm of upper-inner quadrant of right female breastC50.212 Malignant neoplasm of upper-inner quadrant of left female breastC50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast C50.221 Malignant neoplasm of upper-inner quadrant of right male breastC50.222 Malignant neoplasm of upper-inner quadrant of left male breastC50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast C50.311 Malignant neoplasm of lower-inner quadrant of right female breastC50.312 Malignant neoplasm of lower-inner quadrant of left female breastC50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast C50.321 Malignant neoplasm of lower-inner quadrant of right male breastC50.322 Malignant neoplasm of lower-inner quadrant of left male breastC50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breastC50.411 Malignant neoplasm of upper-outer quadrant of right female breastC50.412 Malignant neoplasm of upper-outer quadrant of left female breastC50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast C50.421 Malignant neoplasm of upper-outer quadrant of right male breastC50.422 Malignant neoplasm of upper-outer quadrant of left male breastC50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast C50.511 Malignant neoplasm of lower-outer quadrant of right female breastC50.512 Malignant neoplasm of lower-outer quadrant of left female breastC50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast C50.521 Malignant neoplasm of lower-outer quadrant of right male breastC50.522 Malignant neoplasm of lower-outer quadrant of left male breastC50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breastC50.611 Malignant neoplasm of axillary tail of right female breastC50.612 Malignant neoplasm of axillary tail of left female breastC50.619 Malignant neoplasm of axillary tail of unspecified female breastC50.621 Malignant neoplasm of axillary tail of right male breastC50.622 Malignant neoplasm of axillary tail of left male breastC50.629 Malignant neoplasm of axillary tail of unspecified male breastC50.811 Malignant neoplasm of overlapping sites of right female breastC50.812 Malignant neoplasm of overlapping sites of left female breastC50.819 Malignant neoplasm of overlapping sites of unspecified female breastC50.821 Malignant neoplasm of overlapping sites of right male breastC50.822 Malignant neoplasm of overlapping sites of left male breastC50.829 Malignant neoplasm of overlapping sites of unspecified male breastC50.911 Malignant neoplasm of unspecified site of right female breastC50.912 Malignant neoplasm of unspecified site of left female breastC50.919 Malignant neoplasm of unspecified site of unspecified female breastC50.921 Malignant neoplasm of unspecified site of right male breastC50.922 Malignant neoplasm of unspecified site of left male breastC50.929 Malignant neoplasm of unspecified site of unspecified male breastC61 Malignant neoplasm of prostateC65.1 Malignant neoplasm of right renal pelvisC65.2 Malignant neoplasm of left renal pelvisC65.9 Malignant neoplasm of unspecified renal pelvisC66.1 Malignant neoplasm of right ureterC66.2 Malignant neoplasm of left ureterC66.9 Malignant neoplasm of unspecified ureterC67.0 Malignant neoplasm of trigone of bladderC67.1 Malignant neoplasm of dome of bladderC67.2 Malignant neoplasm of lateral wall of bladderC67.3 Malignant neoplasm of anterior wall of bladderC67.4 Malignant neoplasm of posterior wall of bladderC67.5 Malignant neoplasm of bladder neckC67.6 Malignant neoplasm of ureteric orificeC67.7 Malignant neoplasm of urachusC67.8 Malignant neoplasm of overlapping sites of bladderC67.9 Malignant neoplasm of bladder, unspecifiedC68.0 Malignant neoplasm of urethraD09.0 Carcinoma in situ of bladderZ85.51 Personal history of malignant neoplasm of bladderZ85.59 Personal history of malignant neoplasm of other urinary tract organAppendix 2 – Centers for Medicare and Medicaid Services (CMS)Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at:https:///medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/AJurisdiction Applicable State/US Territory ContractorE (1) CA, HI, NV, AS, GU, CNMI Noridian Healthcare Solutions, LLCF (2 & 3) AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC5 KS, NE, IA, MO Wisconsin Physicians Service Insurance Corp (WPS)6 MN, WI, IL National Government Services, Inc. (NGS)H (4 & 7) LA, AR, MS, TX, OK, CO, NM Novitas Solutions, Inc.8 MI, IN Wisconsin Physicians Service Insurance Corp (WPS) N (9) FL, PR, VI First Coast Service Options, Inc.J (10) TN, GA, AL Palmetto GBA, LLCM (11) NC, SC, WV, VA (excluding below) Palmetto GBA, LLCNovitas Solutions, Inc.L (12) DE, MD, PA, NJ, DC (includes Arlington &Fairfax counties and the city of Alexandria in VA)K (13 & 14) NY, CT, MA, RI, VT, ME, NH National Government Services, Inc. (NGS)15 KY, OH CGS Administrators, LLC。

全自动电泳中文操作指南

Experion™700-7000700-7001 ( , 115 V) 700-7002 ( , 230 V)1 (1)1.1 (1)1.2 (2)1.3 (2)1.3.1 (2)1.3.2 (3)1.3.3 (4)1.3.4 (4)1.3.5 (5)1.4 (5)1.5 (6)1.5.1 (6)1.5.2 (6)1.5.3 & (8)2 (10)2.1 (10)2.2 (11)2.3 (11)2.4 (11)2.5 RNA (14)2.6 (15)3 (16)4 (17)4.1 (17)4.2 (17)4.3 (18)4.4 (18)5 (18)5.1 (18)5.2 (21)5.3 (22)6 (23)6.1 (23)6.2 (23)6.3 (24) (25)A (26)BExperion 10 A/100-240V (115V 230V) ( )Experion(>90%) ExperionExperionEN61010-1 IEC 61010-1EN61010-1 IEC 61010-1EN61010-1 IEC 61010-1AIEC 61010-1 UL 61010-1( ) CAN/CSA C22.2 No. 61010-1( ) Régles de sécurité pour appareils électricques de mesurage de régulation et de laboratoire Partie 1 Prescriptions générales (CEI 1010-1, ) DIN EN 61010-1 class. VDE 0411( )21CFR 11 J EN 60825-1 111.1lab-on-a-chipExperion ( 1.1) LabChip® RNA(1) (2) (3) RNA 1.1 Experion(4) (5) ( ) (a) (b) RNA RNA1.2Experion 3 ( #700-7000) 4 ( #s700-7001 700-7002)• 1— USB 2.0 100–240V• 2— 2 100–240 V• 3—• 4 ( RNA )— 115 V 230 V• ( )•• ( )• .1.31.3.1( 1.3.1a b) 30(1) (2) (3) (4) (5) 1.3.1a.(1) (2) (3)1.3.1b.1.3.2( 1.3.2a b)1.3.2a. ( ) (1) ( ) (2) (3)1.3.2b. ( ) (1) (2) (3)1.3.3( 1.3.3) RNA ( )(1) (2)11.3.3.1.3.41.3.5 ( )( 1.3.5) RNA 10- 25-(1) (2) Pro260 ( ) (3) RNA (1.3.5.) (4) RNA ( )Pro260Experion 10 260 kD 背照背-紧溶璃状紧默o必描峰状xp金默难o高紧默o必描峰状xp金默难o高紧默o必描峰 10 260 kD 度峰RNAExperion RNA RNA RNA RNA ( ) ( ) RNA 11 ( ) 12 ( )1.4• Pentium 3 600 MHz 512 K RAM Windows 2K XP USB • Pentium 4 2GHz 512 K RAM Windows 2K XP USB1.51.5.1.• Experion CD-ROM• Windows Experion• Experion1.5.2.100–240 VAC 50–60 Hz• 10 A/100-240V ( 1.5.2a)• USB 2.0 PC ( 1.5.2b). 1.5.2b. USB 2.01.5.2a.100–240 VAC 50–60 Hz• 10 A/100-240V ( 1.5.2c)1.5.2c.• on/off115 V 230 V ( 1.5.2.d)1.5.2d.(115V 230V) ( )1.5.3 &• ( 1.5.3a) ( 4 )1.5.3a.• Experion ( 4 )•• on/off• (1) (2) (3)(4) ( 1.5.3b)1.5.3b.• / on off on1 ( )off on22.1– 4– Pro260– (~15–20 ) Pro260 DMSO–––– –– 5–2 µl 4 µl 1x PBS/H2O RNA 5 µl 1 µlH2O–––(2.2)2.2RNAddH 2O1. 800 µl Experion2. 23. 800 µl DEPC 54. DEPC5. 301–21. 800 µl DEPC ( RNA ddH20)602. 303.2.3RNA2.41. 1.5.22. ( 2.4a)2.4a3. 804.( 2.4b) ( ) RNA2.4b- GSGS5. ( 2.4d). 2.4d7. Time( 2.4).2.4. .130 245 31:00 41:15 51:30 62:00 7 2:30Pressure8. PrimingCheck seal (1) (2) (3) (4)9.10.Ready11.12.13.14. RNA2.5 RNARNA RNA1.( 2.5). 2.5.2. on 13. 14. off2.6 Running the Analysis1. 1.5.3.2. Experion3. ( 2.6a).2.6a.4. ( 2.6b).. 2.6b.5. Analysis Experion Pro260 RNA StdSensHighSens ( RNA mRNA)6.7. Start OK8. /9. Run Complete10. 800 µl DEPC ( 0.2 µmddH20)11. 60 3012.13. . Experion3/ C Experion4on–– Experionon– Chip error2 µl 4 µl 1xPBS/H2O RNA 5 µl 1 µl H2O–– Start/ ( 5 ) – Start– Check Seal : / ( 5.2 )(1-800-4BIORAD)– Service––(1-800-4BIORAD)–– A4.4-5– RNA ExperionRNase– 10 ( )––––––161)2) USB23)a)b)(1-800-4BIORAD)c)164)165)6)7)8) 909)1) 902) 163)4)5)a.b. 2c.d.– 3-4– ”Check Seal”1)2)3)4)5)1)2)3)––––––1)2)3)4)5)1)2)3)4):–––66.1ABS + ( )( )( )(TPR)ABS + ( )100–240 V AC 50/60 Hz, 31 VA90% 10 % 0.5 mm1 ( )250V T 2A, 5 x 20 mm2200 ( )15–40°C, 0–90%IEC 61010-1 EN 61010-1:2001 UL 61010-1CAN/CSA C22.2 No. 61010-1 EMCEN 61326 AUSB 2.010 1 (4.58 kg) ( × × )15 x 31 x 29 (5.9 x 12.2 x 11.4 )6.2( )( )( )(TPR)100–240 V AC 50/60 Hz, 31 VA50–125 psi30–150IEC 61010-1 EN 61010-1:2001 UL 61010-1CAN/CSA C22.2 No. 61010-1 EMCEN 61326 A3 (1.36 kg) ( × × )9.5 x 26 x 7.5 (3.7 x 10.2 x 3.0 )6.3( )( )115 V AC 50/60 Hz, 31 VA230 V AC 50/60 Hz, 31 VA2 + ( )2 x 630 mA (115 V)2 x 400 mA (230 V)60 (1 )4.5 mmIEC 61010-1 EN 61010-1:2001 UL 61010-1 CAN/CSA C22.2 No. 61010-1CEI 1010-1DIN EN 61010-1 Class. VDE 0411EMC EN 61326 A7 7 (3.5 kg)( × × ) 11.5 x 22.7 x 7.7 (4.5 x 8.9 x 3.0 )A#Experion700-7000 Experion ,100-240 V USB2 ()700-7001 Experion115 VRNAUSB2 ()700-7002 Experion230 VRNAUSB2 ()700-7010 Experion100-240 V USB2700-7020 Experion700-7021 Experion700-7022 Experion USB22.0700-7030 Experion100–240 V 700-7031Experion2700-7040 Experion115 V700-7041 Experion230 V700-7042 ExperionExperion700-7050ExperionPC700-7101 Experion Pro26010700-7102 Experion Pro26025700-7103 Experion RNA StdSens10700-7104 Experion RNA StdSens25700-7105 Experion RNA HighSens10700-7106 Experion RNA HighSens25#700-7151 Experion Pro260 10700-7152 Experion Pro260 10700-7153 Experion RNA StdSens 10700-7154 Experion RNA StdSens 10700-7155 Experion RNA HighSens 10700-7156 Experion RNA HighSens 10 700-7251 Experion 10700-7252 Experion 250 ml700-7253 Experion DEPC 100 ml700-7255 Experion 10BThorsen T, Maerkl SJ, and SR Quake, Microfluidic large-scale integration, Science 298, 580–584 (2002)LabChip LabChip Caliper Technologies Bio-Rad Laboratories, Inc. Caliper TechnologiesWindows Windows 2000 XPLife Science Group Web site USA (800) 4BIORAD Australia 02 9914 2800 Austria (01)-877 89 01 Belgium 09-385 55 11 Brazil 55 21 2527 3454 Canada (905) 712-2771 China (86-21) 63052255 Czech Republic + 420 2 41 43 05 32 Denmark 44 52 10 00 Finland 09 804 22 00 France 01 47 95 69 65 Germany 089 318 84-0 Hong Kong 852-2789-3300 Hungary 36 1 455 8800 India (91-124)-6398112/113/114, 6450092/93 Israel 03 951 4127 Italy 39 02 216091 Japan 03-5811-6270 Korea 82-2-3473-4460 Latin America 305-894-5950 Mexico 55-52-00-05-20 The Netherlands 0318-540666 New Zealand 64 9 415 2280 Norway 23 38 41 30 Poland + 48 22 331 99 99 Portugal 351-21-472-7700 Russia 7 095 721 1404 Singapore 65-6415 3188 South Africa 00 27 11 4428508 Spain 34 91 590 5200 Sweden 08 555 12700 Switzerland 061 717-9555 Taiwan (8862) 2578-7189/2578-7241 United Kingdom 020 8328 2000Sig 110310001312 Rev A。

中心为监管效力的套装700 1 1 堂皇广场，N.W.华盛顿特区20036-1231说明书

I The CRE was sstablislied i n 1996, aflerlhc passagc of thc Conby-essional R w i e w Act, to providc Congress with independent analyscs of agency regulations. CR E has 31.1established record of'calling up011 Cvderal agcncies to obscrve and enforce "good gnvernlnent" laws and procedures, liicluding thl; Pa.pclworlc Reduction Act, the Rcgulalory Flexibility Act, Exccutivt.
MESSAGE:
PLEASE CALL (202)293-5886IF YOU HAVE ANY PROBLEMS WITH THIS
TRANSMITTAL. '?'ELECOPIER NUMBER: (202) 939-6969*
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W-8EXP表格的翻译

第一部分账户持有人资料1.组织名称2.公司或组织所在国家3.实体类型外国政府外国免税机构4.在美国《海外账户纳税法案》中的对应身份加盟的外国金融机构需（向美国国税局）报送信息的模式1的外国金融机构需（向美国国税局）报送信息的模式2的外国金融机构经注册被视为合格的外国金融机构（除了需报送的模式1的外国金融机构）境内金融机构（需完成第三部分）国际组织与机构外国政府（含政府分支机构），美国所属政府，或外国指定银行（需完成第三部分）外国政府退休计划的免试机构（需完成第三部分）第501(c)节所述的组织机构（需完成第三部分）消极的非金融外国法人（需完成第三部分）直接向美国国税局报送的美国联邦雇员工会接受赞助的直接报送的美国联邦雇员工会（需完成第三部分）5.固定地址（街道，公寓或者套房的编号，或者乡邮投递路线）。

不要使用邮政信箱或者转交地址（注册地址除外）。

城市/ 市镇，州/ 省。

适当的地方需标注邮政编码|| 国家6.邮寄地址（如与上述地址不同则需填写）。

城市/ 市镇，州/ 省。

适当的地方需标注邮政编码|| 国家7.如有要求，填写美国纳税人识别号（详情见说明）8. 全球中介机构识别编号外国纳税人识别号（详情见说明）9.参考编码（见说明）第二部分针对第三栏中对应身份（实体类型）的资格声明10.外国政府a. 兹证明，第一部分中所确定的实体是一个在第892节中规定的外国政府且所付款项也在此节所认可的免税范围内。

以下哪个适用就填写哪个：b. 第一部分中所确定的实体是____政府的一个组成部分。

c. 第一部分所确定的实体是一个由____政府管控的实体。

11.国际组织与机构兹证明：•第一部分中所确定的实体是一个在第7701(a)（18）节中规定的国际组织与机构；•其支付款项是在第892节所认可的免税范围内。

12.外国指定银行（也有译为外国中央银行）（非外国主权全资拥有）兹证明：•第一部分中所确定的实体是一家外国指定银行，•这个实体未持有本表格中所提及的用于参与商业银行和其他商业活动中的债务或银行存款，•其支付款项是在第895节中所认可的免税范围内。

Steris Corporations SYSTEM 1E液体化学灭菌处理系统说明书

April 4, 2018Steris CorporationsJennifer NalepkaSenior Regulatory Affairs Specialist5960 Heisley RoadMentor, Ohio 44060Re: K180342Trade/Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing SystemRegulation Number: 21 CFR 880.6885Regulation Name: Liquid Chemical Sterilants/High Level DisinfectantsRegulatory Class: Class IIProduct Code: MEDDated: March 12, 2018Received: March 13, 2018Dear Jennifer Nalepka:We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);U.S. Food & Drug AdministrationPage 2 - Jennifer Nalepka K180342 and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to /MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice(https:///MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn(/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (/DICE) for more information or contact DICE by email (************.gov) or phone (1-800-638-2041 or 301-796-7100).Sincerely,Michael J. Ryan -Sfor Tina Kiang, Ph.D.Acting DirectorDivision of Anesthesiology,General Hospital, Respiratory,Infection Control, and Dental DevicesOffice of Device EvaluationCenter for Devices and Radiological HealthEnclosureDEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for UseForm Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.510(k) Number (if known)K180342Device NameSYSTEM 1E Liquid Chemical Sterilant Processing SystemIndications for Use (Describe)The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for liquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquid chemically sterilize medical devices.* The extensive treatment of EPA potable water consists of: 1. Pre-filtration through two pre-filters:• Pre-filter A is a gross depth filter that removes approximately 2.5 micron or larger particles/contaminants. • Pre-filter B is a surface filter that removes particles/contaminants > 0.1 micron. 2. UV Irradiation:• During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction ofMS2 virus is delivered to the water. 3. 0.1 micron filtration:• The water prepared by pre-filtration and UV irradiation is filtered through redundant, 0.1-micron (absolute rated)membranes to remove bacteria, fungi and protozoa > 0.1 micron.Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff ****************.gov“An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number.”510(k) SummaryForSYSTEM 1E Liquid Chemical Sterilant Processing System STERIS Corporation5960 Heisley RoadMentor, OH 44060Contact: Jennifer NalepkaSenior Regulatory Affairs SpecialistTel: 440-392-7458Fax: 440-357-9198Summary Date: March 27, 2018Premarket Notification Number: K180342STERIS Corporation 5960 Heisley Road Mentor, OH 44060-1834 USA 440-354-26001.Device NameTrade Name: SYSTEM 1E Liquid Chemical SterilantProcessing SystemDevice Classification: Class IICommon/usual Name: Liquid Chemical SterilizerClassification Name: Sterilant, Medical devices, Liquid ChemicalSterilants/DisinfectantsClassification Number: 21 CFR 880.6885Product Code: MED2.Predicate DeviceSYSTEM 1E Liquid Chemical Sterilant Processing System cleared under K170956 3.Description of DeviceThe SYSTEM 1E Liquid Chemical Sterilant Processing System is a liquid chemical sterilization system, utilizing peracetic acid to process totally immersible, heatsensitive, flexible and rigid endoscopes and their accessories, and microsurgicalinstruments. The system consists of the SYSTEM 1E Processor and the S40Sterilant Concentrate, interchangeable processing trays/containers and QuickConnects. The device was originally cleared under K090036. Six Special 510(k)s were cleared that subsequently made minor modifications to hardware, software,specifications, labeling, sterilant and accessories. A Traditional 510(k) was cleared in 2017 adding a new Ultrasound Processing Tray C3000XL and modifying theIndications for Use. The current submission is provided to describe the addition of a second supplier for bacterial retentive water filter, referred to in labeling as theMaxPure filter and A and B Pre-filters and to add an alternate resin for theconstruction of the sterilant capsule.The SYSTEM 1E Processor is an automated, self-contained device which creates and maintains the conditions necessary for liquid chemical sterilization in 6minutes. Following processing, the liquid chemically sterilized articles are rinsed with extensively treated water produced by passing EPA potable tap water through pre-filters, an ultraviolet light treatment subsystem, and then through two 0.1-micron filter membranes. The processor, which is computer controlled andcontinually monitored, provides printed documentation of each cycle.S40 Sterilant Concentrate is a single use chemical sterilant concentrate developed exclusively for use in the SYSTEM 1E Processor. The active ingredient in S40Sterilant Concentrate, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and othermaterials.The interchangeable processing trays/containers are made to accommodate a variety of instrument types, models and procedure specific sets. Each container is designed to maintain instruments in appropriate position while specific Quick Connects for the SYSTEM 1E Processor, if required, facilitate delivery of the liquid chemicalsterilant use dilution and rinse water to internal channels.4.Intended UseThe SYSTEM 1E Liquid Chemical Sterilant Processing System is intended forliquid chemical sterilization of cleaned, immersible, and reusable critical and semi-critical heat-sensitive medical devices in healthcare facilities.The SYSTEM 1E Processor dilutes the S40 Sterilant Concentrate to its use dilution (>1820 mg/L peracetic acid), liquid chemically sterilizes the load during acontrolled 6-minute exposure at 45.5 to 60°C, and rinses the load with extensively treated* potable water. After completion of a cycle, critical devices should be used immediately; semi-critical devices should be used immediately or may be handled and stored in a manner similar to that of high level disinfected endoscopes. Critical devices not used immediately should be processed again before use.The SYSTEM 1E Processor uses only S40 Sterilant Concentrate to liquidchemically sterilize medical devices.* The extensive treatment of EPA potable water consists of:1.Pre-filtration through two pre-filters:•Pre-filter A is a gross depth filter that removes approximately 2.5micron or larger particles/contaminants.•Pre-filter B is a surface filter that removes particles/contaminants >0.1 micron.2.UV Irradiation:•During transit through the UV water treatment chamber, a UV dose sufficient to achieve a > 6-log reduction of MS2 virus is delivered tothe water.3.0.1 micron filtration:•The water prepared by pre-filtration and UV irradiation is filteredthrough redundant, 0.1-micron (absolute rated) membranes to removebacteria, fungi and protozoa > 0.1 micron.5.Description of Technological Similarities and DifferencesThe SYSTEM 1E Liquid Chemical Sterilant Processing System is the same as the predicate device except for the specific modification described in this submission.The differences between the proposed and predicate devices are limited to theaddition of an alternate supplier for the MaxPure Filter and A and B Pre-filters and to add an alternate resin for the construction of the sterilant capsule.These proposed changes raise no new concerns of safety and effectiveness when compared to the predicate device.Device Comparison TableTable 6-1. Processor Device Comparison TableTable 6-2. S40Sterilant Concentrate Device Comparison Table No changes have been made to the S40 Sterilant Concentrate1 Block, S. ed., Disinfection, Sterilization, and Preservation. 5th edition, 2001.2 Clapp et al., Free Rad. Res., (1994) 21:147-167.3 Maillard et. al., J. Med. Microbiol (1995) 42:415-420.4 Maillard et. al., J. Appl Bacteriol (1996) 80:540-554.5 McDonnell et al., J. AOAC International (2000) 83:269-276.Table 6-3 summarizes the verification activity that was performed with its respective acceptance criteria to ensure that this modification does not affect the safety or effectiveness of the SYSTEM 1E Liquid Chemical Sterilant Processing System.Table 6-3. Summary of verification activities.6.ConclusionBased on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate device (K170956), Class II (21 CFR 880.6885), product code MED.。

美国联邦法规CFR第篇食品与药品总目录

美国联邦法规C F R第篇食品与药品总目录 SANY标准化小组 #QS8QHH-HHGX8Q8-GNHHJ8-HHMHGN#美国联邦法规（CFR）第21篇“食品与药品”总目录概述：《美国联邦法规》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。

其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and DrugAdministration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。

第21篇“食品与药品”（Title 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）？1 Ⅰ 1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）？2 100-169？3 170-199？4 200-299？5 300-499？6 500-599？7 600-799？8 800-1299？9 Ⅱ 1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）？Ⅲ 1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL）？1 一般强制执行规章 GENERAL ENFORCEMENT REGULATIONS ？2 一般行政规则与决定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS ？3 产品管辖权 PRODUCT JURISDICTION？5 组织 ORGANIZATION？7 强制执行政策 ENFORCEMENT POLICY？10 行政规范与程序 ADMINISTRATIVE PRACTICES AND PROCEDURES？11电子化记录；电子化签名 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES？12 正式证据的公众听证 FORMAL EVIDENTIARY PUBLIC HEARING？13 在公众质询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY？14 在公众咨询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE？15 在FDA局长前的公众听证 PUBLIC HEARING BEFORE THE COMMISSIONER？16 在FDA前的规制性听证 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION？17 行政罚款听证 CIVIL MONEY PENALTIES HEARINGS？19 行为标准与利益冲突 STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST？20 公共信息 PUBLIC INFORMATION？21 隐私保护 PROTECTION OF PRIVACY？25 环境影响考虑 ENVIRONMENTAL IMPACT CONSIDERATIONS？26药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY？50 人类受试者的保护 PROTECTION OF HUMAN SUBJECTS？54 临床试验者的财务公开 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS？56 机构审查委员会 INSTITUTIONAL REVIEW BOARDS？58对非临床实验室研究的良好实验室规范 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES？60 专利期恢复 PATENT TERM RESTORATION？70 色素添加剂 COLOR ADDITIVES？71 色素添加剂申请 COLOR ADDITIVE PETITIONS？73 免除认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION？74 适用认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION？80 色素添加剂认证 COLOR ADDITIVE CERTIFICATION？81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制 GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS？82 经认证的临时性列表的色素和规范的列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS？83-98 [预留的] [Reserved]？99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）？100 总则 GENERAL ？101 食品标识 FOOD LABELING ？102 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZEDFOODS ？104 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS？105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE ？106 婴儿配方母乳替代食品质量控制程序 INFANT FORMULA QUALITY CONTROL PROCEDURES？107 婴儿配方母乳替代食品 INFANT FORMULA ？108 紧急许可控制 EMERGENCY PERMIT CONTROL ？109 在人类食品与食品-包装材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL？110 在制造、包装或者保存人类食品中的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD111保健品（膳食补充剂）ＧＭＰ要求CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS113 装在密封容器中的热加工低酸食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS？114 酸化食品 ACIDIFIED FOODS ？115 带壳蛋 SHELL EGGS ？119 存在显着或者不合理风险的膳食补充剂 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK ？120 危害分析与关键控制点（HACCP）体系 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS ？123 鱼与渔业产品 FISH AND FISHERY PRODUCTS ？129 饮用水加工与装瓶 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER ？130 食品标准：总则 FOOD STANDARDS: GENERAL ？131 乳与奶油 MILK AND CREAM ？133 乳酪与相关乳酪产品 CHEESES AND RELATED CHEESE PRODUCTS ？135 冷冻点心 FROZEN DESSERTS ？136 烘焙产品 BAKERY PRODUCTS ？137 谷物粉与相关产品 CEREAL FLOURS AND RELATED PRODUCTS ？139 通心粉与面条产品 MACARONI AND NOODLE PRODUCTS ？145 罐装水果 CANNED FRUITS ？146 罐装水果汁 CANNED FRUIT JUICES ？150 水果黄油、果冻、防腐剂以及相关产品 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS ？152 水果馅饼 FRUIT PIES ？155 罐装蔬菜 CANNED VEGETABLES ？156 蔬菜汁 VEGETABLE JUICES ？158 冷冻蔬菜 FROZEN VEGETABLES ？160 蛋与蛋制品 EGGS AND EGG PRODUCTS ？161 鱼与有壳的水生动物 FISH AND SHELLFISH ？163 可可制品 CACAO PRODUCTS ？164 树坚果与花生制品 TREE NUT AND PEANUT PRODUCTS ？165 饮料 BEVERAGES ？166 人造黄油 MARGARINE ？168 增甜剂与餐桌糖浆 SWEETENERS AND TABLE SIRUPS ？169 食品敷料与调味料 FOOD DRESSINGS AND FLAVORINGS ？170 食品添加剂 FOOD ADDITIVES ？171 食品添加剂申请 FOOD ADDITIVE PETITIONS ？172 允许直接加入用于人类消费食品的食品添加剂 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION？173 在用于人类消费的食品中允许的次直接的食品添加剂 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION ？174 间接食品添加剂：总则 INDIRECT FOOD ADDITIVES: GENERAL ？175 间接食品添加剂：胶粘剂与涂层的组分 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS ？176 间接食品添加剂：纸与纸板组分 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS ？177 间接食品添加剂：聚合体 INDIRECT FOOD ADDITIVES: POLYMERS ？178 间接食品添加剂：辅剂、生产助剂和消毒剂 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS ？179 在食品生产、加工和处理中的辐照 IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD ？180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY ？181 先前核准的食品配料 PRIOR-SANCTIONED FOOD INGREDIENTS ？182 一般认为安全的物质 SUBSTANCES GENERALLY RECOGNIZED AS SAFE？184 被确认为一般认为安全的直接食品物质 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE ？186 被确认为一般认为安全的间接食品物质 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE ？189禁止用于人类食品的物质 SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD ？190 膳食补充剂 DIETARY SUPPLEMENTS ？191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）？200 总则 GENERAL ？201 标识 LABELING ？202 处方药广告 PRESCRIPTION DRUG ADVERTISING ？203 处方药销售 PRESCRIPTION DRUG MARKETING ？205 对批发处方药销售商颁发州执照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS ？206 人用固体口服剂型药品的印码 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE ？207 药品生产者的登记与商业销售的药品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION？208 处方药的药物治疗指导 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS ？210制造、加工、包装或者保存药品的现行良好制造规范；总则 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL ？211药品现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ？216 药房配药 PHARMACY COMPOUNDING ？225含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS ？226含A类药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES ？250特殊人用药品的特殊要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS ？290管制药品 CONTROLLED DRUGS ？299 药品；正式名称与已确定的名称 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）？300 总则 GENERAL ？310新药 NEW DRUGS ？312 试验用新药申请 INVESTIGATIONAL NEW DRUG APPLICATION？314 FDA批准上市新药的申请 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG ？315诊断用放射性药品 DIAGNOSTIC RADIOPHARMACEUTICALS ？316罕见病药 ORPHAN DRUGS ？320生物利用度与生物等效性要求 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS ？328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL？330一般认为安全有效以及不错贴标签的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED ？331 非处方人用抗酸产品 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE ？332 非处方人用抗胃肠气胀产品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？333非处方人用局部抗菌药品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？335非处方人用止泻药品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？336非处方人用止吐药品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？338 非处方人用助睡眠药品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？340 非处方人用兴奋药品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？341非处方人用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？343非处方人用内服止痛、退热以及抗风湿药品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？344 非处方人用局部耳部药品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？346 非处方人用肛肠药品 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？347 非处方人用皮肤保护药品 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？348 非处方人用外用止痛药品 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？349非处方人用眼科药品 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？350非处方人用止汗药品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？352非处方人用防晒药品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] ？355 非处方人用防龋药品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？357 非处方人用其他内服药品 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？358非处人用的其他外用药品 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？361 一般认为安全与有效以及不错贴标签的处方人用药品：用于研究的药品 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH ？369 在非处方销售药品与器械上关于警告解释性声明 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE？370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）？500 总则 GENERAL ？501 动物食品标识 ANIMAL FOOD LABELING ？502 非标准化动物食品的普通或通常名称 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS ？509 在动物食品与食品-包装材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL ？510新动物药 NEW ANIMAL DRUGS ？511 作为试验用途的新动物药 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE？514 新动物药申请 NEW ANIMAL DRUG APPLICATIONS？515 含药饲料厂执照 MEDICATED FEED MILL LICENSE ？520 口服剂型的新动物药 ORAL DOSAGE FORM NEW ANIMAL DRUGS ？522 植入或者注射剂型的新动物药 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS ？524 眼科和局部剂型的新动物药 OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS ？526 乳房内的剂型 INTRAMAMMARY DOSAGE FORMS ？529 某些其他剂型的新动物药 CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS？530 在动物中的特别标签药品使用 EXTRALABEL DRUG USE IN ANIMALS ？556 在食品中新动物药残留的容许量 TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD ？558 用于动物饲料的新动物药 NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS？564 [预留的] [Reserved]？570 食品添加剂 FOOD ADDITIVES ？571 食品添加剂申请 FOOD ADDITIVE PETITIONS ？573 在动物饲料与饮用水中允许的食品添加剂 FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS ？579 在动物饲料和宠物食品的生产、加工和处理中的辐照 IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD？582 一般认为安全的物质 SUBSTANCES GENERALLY RECOGNIZED AS SAFE？584 在动物饲料与饮用水中被确认为一般认为安全的食品物质 FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS ？589 禁止用于动物食品或者饲料的物质 SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED ？590-599 [预留的] [Reserved]？第F分章―生物制品（SUBCHAPTER F―BIOLOGICS）？600 生物制品：总则 BIOLOGICAL PRODUCTS: GENERAL ？601 颁发执照 LICENSING ？606对血液与血液组分的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS ？607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS ？610普通生物制品标准 GENERAL BIOLOGICAL PRODUCTS STANDARDS ？630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES ？640 对人类血液和血液制品的附加标准 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS ？660 对用于实验室检测的诊断物质的附加标准 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS ？680 对其他产品的附加标准 ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）？700 总则 GENERAL ？701 化妆品标识 COSMETIC LABELING ？710 化妆品机构的自愿登记 VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS ？720 化妆品配料构成声明的自愿存档 VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS ？740 化妆品警告声明 COSMETIC PRODUCT WARNING STATEMENTS ？741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）？800 总则 GENERAL ？801 标识 LABELING ？803 医疗器械报告 MEDICAL DEVICE REPORTING ？806 医疗器械；改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS ？807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES ？808 对州和地方医疗器械要求的联邦优先权的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS ？809 人用体外诊断产品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE？810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY ？812 试验用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS ？813 [预留的] [Reserved]？814 医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES ？820 质量体系规章 QUALITY SYSTEM REGULATION ？821 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS ？822 上市后监视 POSTMARKET SURVEILLANCE ？860 医疗器械分类程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES？861 性能标准制定程序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT ？862 临床化学与临床毒理学器械 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES ？864 血液学与病理学器械 HEMATOLOGY AND PATHOLOGY DEVICES ？866 免疫学与微生物学器械 IMMUNOLOGY AND MICROBIOLOGY DEVICES ？868 麻醉学器械 ANESTHESIOLOGY DEVICES ？870 心血管器械 CARDIOVASCULAR DEVICES ？872 牙科器械 DENTAL DEVICES ？874 耳、鼻和咽器械 EAR, NOSE, AND THROAT DEVICES ？876 胃肠病学-泌尿学器械 GASTROENTEROLOGY-UROLOGY DEVICES ？878 普通与整形外科器械 GENERAL AND PLASTIC SURGERY DEVICES ？880 普通医院与个人使用器械 GENERAL HOSPITAL AND PERSONAL USE DEVICES？882 神经学器械 NEUROLOGICAL DEVICES ？884 产科与妇科学器械 OBSTETRICAL AND GYNECOLOGICAL DEVICES ？886 眼科器械 OPHTHALMIC DEVICES ？888 矫形外科器械 ORTHOPEDIC DEVICES ？890 内科学器械 PHYSICAL MEDICINE DEVICES ？892 放射学器械 RADIOLOGY DEVICES ？895 禁止的器械 BANNED DEVICES ？898 电极铅线与患者电缆的性能标准 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）？900 乳房造影法 MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）？1000 总则 GENERAL ？1002 记录与报告 RECORDS AND REPORTS ？1003 缺陷与未能守法的通报 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY ？1004 电子产品的回购、修理或者置换 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS ？1005 电子产品的进口 IMPORTATION OF ELECTRONIC PRODUCTS ？1010 电子产品的性能标准：总则 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL ？1020 电离辐射发生产品的性能标准 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS ？1030 微波与射电频率发生产品的性能标准 PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS ？1040 发光产品的性能标准 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS ？1050 声波、次声波和超声波发生产品的性能标准 PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS ？第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）？1210 根据《联邦进口乳法》的规章 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT ？1230 根据《联邦腐蚀性毒物法》的规章 REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT ？1240 传染病的控制 CONTROL OF COMMUNICABLE DISEASES ？1250 州际运输卫生 INTERSTATE CONVEYANCE SANITATION ？1251-1269 [预留的] [Reserved]？1270 预期用于移植的人体组织 HUMAN TISSUE INTENDED FOR TRANSPLANTATION？1271 人体细胞、组织以及细胞的和基于组织的产品 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS ？1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）？1300 定义 DEFINITIONS ？1301 管制物质的制造者、分销者和调剂者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES ？1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES ？1303 定额 QUOTAS ？1304 登记者的记录与报告 RECORDS AND REPORTS OF REGISTRANTS ？1305 令的格式 ORDER FORMS ？1306 处方 PRESCRIPTIONS ？1307 杂项 MISCELLANEOUS ？1308 管制物质的表 SCHEDULES OF CONTROLLED SUBSTANCES ？1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS ？1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES ？1311 [预留的] [Reserved]？1312 管制物质的进口与出口 IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES ？1313 前体与必要化学品的进口与出口 IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS ？1314-1315 [预留的] [Reserved]？1316 行政职能、规范和程序 ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）？1400 [预留的] [Reserved]？1401 信息的公众可及性 PUBLIC AVAILABILITY OF INFORMATION ？1402 强制性解密审查 MANDATORY DECLASSIFICATION REVIEW ？1403 对给予州和地方政府资金和合作协议的统一行政要求 UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS ？1404 政府范围的排除与暂停（非获得） GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) ？1405 对无毒品工作场所的政府范围的要求（财政援助） GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) ？1406-1499 [预留的] [Reserved]。

卫生元数据标准

附件1一、卫生部《卫生信息数据元目录》（卫通[2011］13号）（本部分参照卫生部标准）《WS 363。

1—2011 卫生信息数据元目录第1部分：总则》《WS 363。

2-2011 卫生信息数据元目录第2部分：标识》《WS 363。

3—2011 卫生信息数据元目录第3部分：人口学及社会经济学特征》《WS 363.4—2011 卫生信息数据元目录第4部分：健康史》《WS 363。

5—2011 卫生信息数据元目录第5部分：健康危险因素》《WS 363.6—2011 卫生信息数据元目录第6部分:主诉与症状》《WS 363。

7-2011 卫生信息数据元目录第7部分:体格检查》《WS 363.8—2011 卫生信息数据元目录第8部分：临床辅助检查》《WS 363.9-2011 卫生信息数据元目录第9部分:实验室检查》《WS 363.10-2011 卫生信息数据元目录第10部分:医学诊断》《WS 363。

11-2011 卫生信息数据元目录第11部分:医学评估》《WS 363。

12—2011 卫生信息数据元目录第12部分:计划与干预》《WS 363.13—2011 卫生信息数据元目录第13部分:卫生费用》《WS 363。

14-2011 卫生信息数据元目录第14部分：卫生机构》《WS 363。

15—2011 卫生信息数据元目录第15部分：卫生人员》《WS 363。

16—2011 卫生信息数据元目录第16部分：药品、设备与材料》《WS 363。

17—2011 卫生信息数据元目录第17部分：卫生管理》《WS 364。

1—2011 卫生信息数据元值域代码第1部分：总则》《WS 364.2-2011 卫生信息数据元值域代码第2部分：标识》《WS 364.3-2011 卫生信息数据元值域代码第3部分：人口学及社会经济学特征》《WS 364。

4-2011 卫生信息数据元值域代码第4部分:健康史》《WS 364.5—2011 卫生信息数据元值域代码第5部分:健康危险因素》《WS 364.6—2011 卫生信息数据元值域代码第6部分:主诉与症状》《WS 364。

用药合理性鉴定申请书

用药合理性鉴定申请书英文回答：Drug Rationality Assessment Application.Patient Information.Name: [Patient Name]Age: [Patient Age]Sex: [Patient Sex]Medical History: [Patient Medical History] Drug Information.Name: [Drug Name]Dose: [Drug Dose]Route of Administration: [Drug Route of Administration]Frequency of Administration: [Drug Frequency of Administration]Duration of Therapy: [Drug Duration of Therapy]Clinical Indication.Diagnosis: [Diagnosis]Symptoms: [Symptoms]Assessment.1. Is the drug indicated for the clinical condition?2. Is the dose appropriate for the patient's age, weight, and renal function?3. Is the route of administration appropriate for thepatient's needs?4. Is the frequency of administration appropriate for the drug's pharmacokinetics and patient's condition?5. Is the duration of therapy appropriate for the clinical condition and patient's response?6. Are there any potential drug interactions or adverse effects that should be considered?7. Are there any alternative drugs that may be more appropriate for the patient?Recommendation.Based on the assessment, the following recommendation is made:Continue the current drug therapy.Modify the drug therapy as follows: [ModificationDescription]Discontinue the current drug therapy.中文回答：用药合理性鉴定申请书。

Eaton Aerospace产品说明书

Manual (ATA Number)CurrentRevisionRevisionDateEaton PartNumberDescription OEM Application63-41-10Rev 1Mar 31/981H118-45QDM Signal Conditioner Agusta Westland EH10163-41-20Initial Feb 15/02S247-4Sight Gauge Agusta AB13979-22-06Rev 2Jul 30/991A475Chip Collector GE CF679-24-01Reissue Apr 15/94A693Full Flow Debris Monitor Textron Lycoming ALF502/ LF507 79-22-06Rev 2Jul 30/991A1869Chip Collector GE CF679-24-01Reissue Apr 15/941D1934Full Flow Debris Monitor Textron Lycoming ALF502/ LF507 79-24-01Reissue Apr 15/941D2316Full Flow Debris Monitor Textron Lycoming ALF502/ LF507 79-22-11Initial Feb 1/941J2496Power Module Israel Cobra79-23-00Initial Feb 28/941F2870-3Lubriclone Allison AE210079-21-39Rev 2Sep 30/991F2976SeriesDMS Separator Hispano-Suiza GE9079-21-38Rev 1Aug 31/991G2977SeriesDMS Sensor Hispano-Suiza GE9079-21-41Rev 1Apr 30/991H2983-3DMS Conditioner Hispano-Suiza GE9049-90-30Initial Jan 18/082E3249Level Sensor Honeywell36-150 APU79-21-03Rev 1May 24/96VB3447Chip Detector Rolls-Royce RB21179-21-04Rev 1May 10/96VA3503Chip Detector Rolls-Royce RB21179-21-05Rev 2Feb 15/01VA3508Chip Detector Rolls-Royce BR710, TRENT700/80079-22-45Rev 3Nov 1/99VB3521-2Chip Detector Rolls-Royce V250079-22-06Rev 2Jul 30/99B4354-1Chip Detector GE CF679-22-08Rev 1Mar 31/99B4901Chip Detector w/Self-ClosingValve Pratt & Whitney PW2000F117PW-10079-22-14Rev 1May 9/08B4902Chip Detector w/Self-ClosingValvePratt & Whitney PW400079-22-14Rev 1May 9/08B4903Chip Detector w/Self-ClosingValvePratt & Whitney PW400079-23-00Initial Feb 28/942Z6468Self-Closing Valve Allison AE2100 79-22-02Rev 2Nov 19/991A6473Chip Detector w/Self-ClosingValvePratt & Whitney PW4000 79-22-03Initial Jul 15/931B6488Chip Detector w/ Self-ClosingValvePratt & Whitney PW400079-22-02Rev 2Nov 19/991A6505Chip Detector w/Self-ClosingValvePratt & Whitney PW4000 79-21-51Rev 2Nov 17/061D6549Debris Monitor Hispano-Suiza CFM56 79-21-52Rev 1Oct 20/001B6550Chip Detector Hispano-Suiza CFM56 79-31-10Rev 2May 9/944J6588Electric Chip Detector GE LM6000 79-22-04Initial Oct 15/921A6618Chip Collector w/Self-ClosingValveGarrett APU79-22-10Initial Dec 15/971A6794Chip Collector w/Self-ClosingValveIAE V250079-23-00Initial Feb 28/941B6820Chip Detector Allison AE2100 79-23-05Initial Jun 1/981F6875Lubriclone Rolls-Royce AE1107C 79-22-07Initial Mar 15/951A6902Chip Collector w/Self-ClosingValvePratt & Whitney JT9D79-22-07Initial Mar 15/951A6925Chip Collector w/Self-ClosingValvePratt & Whitney JT9D79-22-09Rev 2Jan 3/001A6945Chip Collector w/Self-ClosingValvePratt & Whitney JT8D79-22-09Rev 2Jan 3/001A6947Chip Collector w/Self-ClosingValvePratt & Whitney JT8D79-22-09Rev 2Jan 3/001A6948Chip Collector w/Self-ClosingValvePratt & Whitney JT8D79-22-12Initial Sep 15/961A7091Chip Collector w/Self-ClosingValvePratt & Whitney JT9D79-22-16Initial Dec 15/971A7476Chip Collector w/Self-ClosingValveRolls-Royce BR715Manual (ATA Number)CurrentRevisionRevisionDateEaton PartNumberDescription OEM Application77-42-03Initial Jan 03/001J7589Smart Zapper Power Module Westland Seaking77-42-04Initial Jan 03/001Z7628Smart Zapper Maint. Panel Westland Seaking79-22-16Initial Dec 15/971A7802Chip Collector w/Self-ClosingValveRolls-Royce BR71579-22-46Rev 1Jan 29/041B7802Chip Detector Rolls-Royce TRENT 500/900 79-22-47Initial Dec 29/062Z7802DMS Inhibitor Rolls-Royce TRENT 500/900 63-41-20Initial Feb 15/021D7829Debris Monitor Agusta AB13963-41-20Initial Feb 15/021B7830Chip Detector w/Adapter Agusta AB13963-41-20Initial Feb 15/022A7831Oil Filler Agusta AB13963-41-20Initial Feb 15/021B7839Chip Detector w/SCV Agusta AB13963-41-20Initial Feb 15/022A7840-1Oil Filler Agusta AB13963-41-20Initial Feb 15/022B7841Vented Breather Agusta AB13963-41-21Initial Feb 15/021J7895Power Module Agusta AB13979-11-24Initial Apr 14/041F8550DMS Separator Hispano-Suiza GE90-115B63-41-20Initial Feb 15/022F8566E/O Sensor Agusta AB13979-36-13Initial Jun 30/061F8664-4ODM Separator GE GP7200。

211213524_身体约束缩减策略结合人性化护理干预在重症患者中的应用效果及对护理满意度的影响分析

临床护理DOI：10.16662/ki.1674-0742.2022.34.165身体约束缩减策略结合人性化护理干预在重症患者中的应用效果及对护理满意度的影响分析凌碧珍，王彦芬，郑丽华福建医科大学附属宁德市闽东医院重症医学科，福建宁德355000［摘要］目的探讨身体约束缩减策略结合人性化护理干预在重症患者中的应用效果。

方法简单随机选取2018年1月—2020年12月重症医学科收治的100例重症患者，随机分为研究组（50例）与对照组（50例），对照组接受人性化护理与常规身体约束干预，研究组接受人性化护理结合身体约束缩减策略。

对比两组焦虑评分（HAMA）、护理满意度、抑郁评分（HAMD）及不良事件发生情况。

结果干预前两组HAMD、HAMA评分差异无统计学意义（P>0.05），干预后研究组HAMD、HAMA评分低于对照组，差异有统计学意义（P<0.05）；研究组总满意率（98.00% vs 84.00%）高于对照组，差异有统计学意义（χ2=4.396，P<0.05）；研究组总不良事件率（8.00% vs 24.00%）低于对照组，差异有统计学意义（χ2=4.762，P<0.05）。

结论身体约束缩减策略联合人性化护理可有效减轻重症患者负性情绪，降低谵妄、肢体肿胀等并发症发生风险，提高患者护理满意度。

［关键词］重症医学科；身体约束缩减策略；重症患者；人性化护理；护理满意度［中图分类号］R473 ［文献标识码］A ［文章编号］1674-0742（2022）12(a)-0165-05Effect of Physical Restraint Reduction Strategy Combined with Human⁃ized Nursing Intervention in Severe Patients and Its Influence on Nursing SatisfactionLING Bizhen, WANG Yanfen, ZHENG LihuaDepartment of Critical Care medicine, Mindong Hospital Affiliated to Fujian Medical University, Ningde, Fujian Prov⁃ince, 355000 China[Abstract] Objective To explore the effect of physical restraint reduction strategy combined with humanized nursing intervention in severe patients.Methods Simp random selection of 100 critically ill patients admitted to the Depart⁃ment of Critical Care Medicine from January 2018 to December 2020 were randomly divided into study group (50 cases) and control group (50 cases). The control group received humanized nursing and routine physical restraint inter⁃vention.The study group received humanized nursing combined with physical restraint reduction strategy. The anxiety score (HAMA), nursing satisfaction,depression score (HAMD) and occurrence of adverse events were compared be⁃tween the two groups. Results There was no significant difference in HAMD and HAMA scores between the two groups before intervention (P>0.05). After intervention, the HAMD and HAMA scores of the study group were lower than those of the control group, and the difference was statistically significant (P<0.05). The total satisfaction rate of the study group(98.00% vs 86.00%) was higher than that of the control group, and the difference was statistically sig⁃nificant (χ2=4.396, P<0.05). The total adverse event rate of the study group (8.00% vs 24.00%) was lower than that of the control group, and the difference was statistically significant (χ2=4.762, P<0.05). Conclusion Physical restraint re⁃duction strategy combined with humanized nursing can effectively reduce negative emotions in severe patients, reduce the risk of complications such as delirium and limb swelling, and improve patients' nursing satisfaction.[Key words] Intensive care medicine; Physical restraint reduction strategy; Severe patients; Humanized nursing; Nursing satisfaction[作者简介] 凌碧珍（1987-），女，本科，主管护师，研究方向为重症护理。

Soft Care Dove Cream Wash H2 安全数据表说明书

Soft Care Dove Cream Wash H2Revision: 2017-09-09Version:06.1Safety Data SheetAccording to Regulation (EC) No 1907/2006SECTION 1: Identification of the substance/mixture and of the company/undertaking1.1 Product identifierTrade name: Soft Care Dove Cream Wash H2Dove is a registered trade mark and is used under licence of Unilever1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses:Cosmetic productUses advised against: Uses other than those identified are not recommended 1.3 Details of the supplier of the safety data sheet Contact detailsUnilever UK Ltd., Freepost ADM1000, London SW1A 2XX Tel: 0800 776647Diversey LtdWeston Favell Centre, Northampton NN3 8PD, United Kingdom Tel: 01604 405311, Fax: 01604 4068091.4 Emergency telephone numberFor medical or environmental emergency only:call 0800 052 0185SECTION 2: Hazards identification2.1 Classification of the substance or mixtureThe product is exempted from classification requirements.2.2 Label elements2.3 Other hazardsNo other hazards knownThe product does not meet the criteria for PBT or vPvB in accordance with Regulation (EC) No 1907/2006, Annex XIIISECTION 3: Composition/information on ingredients3.2 MixturesCosmetic product. For ingredients see INCI declaration on product label.SECTION 4: First aid measures4.1 Description of first aid measures Inhalation:Get medical attention or advice if you feel unwell.Skin contact:Wash skin with plenty of lukewarm, gently flowing water. If skin irritation occurs: Get medical advice or attention.Eye contact:Rinse cautiously with water for several minutes. If irritation occurs and persists, get medical attention.Ingestion:Rinse mouth. Immediately drink 1 glass of water. Never give anything by mouth to an unconscious person. Get medical attention or advice if you feel unwell.Self-protection of first aider:Consider personal protective equipment as indicated in subsection 8.2.4.2 Most important symptoms and effects, both acute and delayedInhalation:No known effects or symptoms in normal use.Skin contact:No known effects or symptoms in normal use.Eye contact:No known effects or symptoms in normal use.Ingestion:No known effects or symptoms in normal use.4.3 Indication of any immediate medical attention and special treatment neededNo information available on clinical testing and medical monitoring. Specific toxicological information on substances, if available, can be found in section 11.SECTION 5: Firefighting measures5.1 Extinguishing mediaCarbon dioxide. Dry powder. Water spray jet. Fight larger fires with water spray jet or alcohol-resistant foam.5.2 Special hazards arising from the substance or mixtureNo special hazards known.5.3 Advice for firefightersAs in any fire, wear self contained breathing apparatus and suitable protective clothing including gloves and eye/face protection. SECTION 6: Accidental release measures6.1 Personal precautions, protective equipment and emergency proceduresNo special measures required.6.2 Environmental precautionsDo not allow to enter drainage system, surface or ground water. Dilute with plenty of water.6.3 Methods and material for containment and cleaning upAbsorb with liquid-binding material (sand, diatomite, universal binders, sawdust).6.4 Reference to other sectionsFor personal protective equipment see subsection 8.2. For disposal considerations see section 13.SECTION 7: Handling and storage7.1 Precautions for safe handlingMeasures to prevent fire and explosions:No special precautions required.Measures required to protect the environment:For environmental exposure controls see subsection 8.2.Advices on general occupational hygiene:Handle in accordance with good industrial hygiene and safety practice. Do not mix with other products unless adviced by Diversey.7.2 Conditions for safe storage, including any incompatibilitiesStore in accordance with local and national regulations. Keep only in original container.For conditions to avoid see subsection 10.4. For incompatible materials see subsection 10.5.7.3 Specific end use(s)No specific advice for end use available.SECTION 8: Exposure controls/personal protection8.1 Control parameters8.2 Exposure controlsThe following information applies for the uses indicated in subsection 1.2 of the Safety Data Sheet.If available, please refer to the product information sheet for application and handling instructions.Normal use conditions are assumed for this section.Recommended safety measures for handling the undiluted product:Appropriate engineering controls: No special requirements under normal use conditions.Appropriate organisational controls: No special requirements under normal use conditions.Personal protective equipmentEye / face protection: No special requirements under normal use conditions.Hand protection: Not applicable.Body protection: No special requirements under normal use conditions.Respiratory protection: No special requirements under normal use conditions.Environmental exposure controls: No special requirements under normal use conditions.SECTION 9: Physical and chemical properties9.1 Information on basic physical and chemical propertiesInformation in this section refers to the product, unless it is specifically stated that substance data is listedPhysical State: LiquidColour: Opaque, WhiteOdour: Slightly perfumedOdour threshold: Not applicable( UN Manual of Tests and Criteria, section 32, L.2 )Solubility in / Miscibility with Water: Fully miscibleDecomposition temperature: Not applicable.9.2 Other informationSECTION 10: Stability and reactivity10.1 ReactivityNo reactivity hazards known under normal storage and use conditions. 10.2 Chemical stabilityStable under normal storage and use conditions.10.3 Possibility of hazardous reactionsNo hazardous reactions known under normal storage and use conditions.10.4 Conditions to avoidNone known under normal storage and use conditions.10.5 Incompatible materialsNone known under normal use conditions.10.6 Hazardous decomposition products Method / remarkpH: ≈5(n e a t)Melting point/freezing point (°C): Not determined Not relevant to classification of this product Initial boiling point and boiling range (°C): Not determinedMethod / remarkFlash point (°C): Not applicable.Sustained combustion: Not applicable.Evaporation rate: Not determinedFlammability (solid, gas): Not determinedUpper/lower flammability limit (%): Not determinedMethod / remarkVapour pressure: Not determinedMethod / remarkVapour density: Not determinedRelative density: ≈1.03(20°C)Method / remarkAutoignition temperature: Not determinedViscosity: ≈3600m P a.s(20°C)Explosive properties: Not explosive.Oxidising properties: Not oxidising.Surface tension (N/m): Not determined Not relevant to classification of this product Corrosion to metals: Not corrosiveNone known under normal storage and use conditions.SECTION 11: Toxicological information11.1 Information on toxicological effectsThis product does not legally require a safety data sheet. This document does therefore not necessarily comply with the requirements on safety data sheets.Relevant calculated ATE(s):ATE - Oral (mg/kg): >5000Potential adverse health effects and symptomsEffects and symptoms related to the product, if any, are listed in subsection 4.2.SECTION 12: Ecological information12.1 ToxicityThis product does not legally require a safety data sheet. This document does therefore not necessarily comply with the requirements on safety data sheets.12.2 Persistence and degradabilityAbiotic degradation Not applicable.Abiotic degradation - photodegradation in air, if available: Not applicable.12.3 Bioaccumulative potentialPartition coefficient n-octanol/water (log Kow) Not applicable.12.4 Mobility in soilAdsorption/Desorption to soil or sediment Not applicable.12.5 Results of PBT and vPvB assessment.12.6 Other adverse effectsSECTION 13: Disposal considerations 13.1 Waste treatment methodsWaste from residues / unused products:The concentrated contents or contaminated packaging should be disposed of by a certified handler or according to the site permit. Release of waste to sewers is discouraged. The cleaned packaging material is suitable for energy recovery or recycling in line with local legislation.European Waste Catalogue: 20 01 30 - detergents other than those mentioned in 20 01 29.Empty packagingRecommendation:Dispose of observing national or local regulations.Suitable cleaning agents:Water, if necessary with cleaning agent.SECTION 14: Transport informationLand transport (ADR/RID), Sea transport (IMDG), Air transport (ICAO-TI / IATA-DGR)14.1 UN number: Non-dangerous goods14.2 UN proper shipping name: Non-dangerous goods14.3 Transport hazard class(es): Non-dangerous goodsClass: -14.4 Packing group: Non-dangerous goods14.5 Environmental hazards: Non-dangerous goods14.6 Special precautions for user: Non-dangerous goods14.7 Transport in bulk according to Annex II of MARPOL and the IBC Code: Non-dangerous goodsSECTION 15: Regulatory information15.1 Safety, health and environmental regulations/legislation specific for the substance or mixtureEU regulations:•R e g u l a t i o n(E C)N o1223/2009o n c o s m e t i c p r o d u c t sAuthorisations or restrictions (Regulation (EC) No 1907/2006, Title VII respectively Title VIII): Not applicable.15.2 Chemical safety assessmentNot applicable.SECTION 16: Other informationThe information in this document is based on our best present knowledge. However, it does not constitute a guarantee for any specific product features and does not establish a legally binding contractReason for revision:This data sheet contains changes from the previous version in section(s):, 3End of Safety Data SheetSDS code: MSDS4544Version: 06.1Revision: 2017-09-09。

聚氨酯零件的安全预防措施MSDS

according to Regulation (EC) No 1907/2006Safety Data SheetWEVOPUR 3901.1. Product identifier1.2. Relevant identified uses of the substance or mixture and uses advised againstUse of the substance/mixtureResin/Polyol components for the production of polyurethanes 1.3. Details of the supplier of the safety data sheetCompany name:Street:Place:Post-office box:Telephone:e-mail:e-mail (Contact person):Internet:1.4. Emergency telephone number:2.1. Classification of the substance or mixtureRegulation (EC) No. 1272/2008Hazard categories:Respiratory or skin sensitisation: Skin Sens. 1Hazardous to the aquatic environment: Aquatic Acute 1Hazard Statements:May cause an allergic skin reaction.Very toxic to aquatic life.2.2. Label elementsRegulation (EC) No. 1272/2008Hazard components for labellingFatty acids, C18-unsaturated, trimers, compounds with oleylamine Fatty acids, tall oil, compounds with oleylamineReaction mass of 3-methylphenyl diphenyl phosphate, 4-methylphenyl diphenyl phospha-te,bis(3-methylphenyl) phenyl phosphate, 3-methylphenyl 4-methylphenyl phenyl phosphate and triphenyl phosphate Signal word:WarningPictograms:H317May cause an allergic skin reaction.H400Very toxic to aquatic life.Hazard statementsP261Avoid breathing dust/fume/gas/mist/vapours/spray.P273Avoid release to the environment.P280Wear protective gloves/protective clothing/eye protection/face protection/hearingprotection.P302+P352IF ON SKIN: Wash with plenty of soap and water.P333+P313If skin irritation or rash occurs: Get medical advice/attention.Precautionary statementsP362+P364Take off contaminated clothing and wash it before reuse.P391Collect spillage.P501Dispose of contents/container to an appropriate recycling or disposal facility.2.3. Other hazardsNo information available.3.2. MixturesChemical characterizationpreparation based on polyurethanesHazardous componentsFull text of H and EUH statements: see section 16.Further InformationThis product contains no substances of very high concern in concentrations where an information obligation applies (REACH Regulation (EC) No. 1907/2006, Article 59).4.1. Description of first aid measuresGeneral informationRemove contaminated, saturated clothing immediately.After inhalationProvide fresh air. If breathing is irregular or stopped, administer artificial respiration. Medical treatmentnecessary. If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable forbreathing.After contact with skinAfter contact with skin, wash immediately with plenty of water and soap. Take off immediately all contaminatedclothing and wash it before reuse. If skin irritation occurs: Get medical advice/attention.After contact with eyesIn case of contact with eyes, rinse immediately with plenty of flowing water for 10 to 15 minutes holding eyelids apart. Subsequently consult an ophthalmologist.After ingestionRinse mouth immediately and drink plenty of water. Do NOT induce vomiting. Call a physician immediately.4.2. Most important symptoms and effects, both acute and delayedNo information available.4.3. Indication of any immediate medical attention and special treatment neededTreat symptomatically.5.1. Extinguishing mediaSuitable extinguishing mediaCarbon dioxide (CO2), Foam, Dry extinguishing powder, Water mist, Water spray jet. Co-ordinate fire-fighting measures to the fire surroundings.Unsuitable extinguishing mediaFull water jet5.2. Special hazards arising from the substance or mixtureNon-flammable. In case of fire may be liberated: Carbon monoxide, Carbon dioxide (CO2), Nitrogen oxides (NOx)In case of fire and/or explosion do not breathe fumes.5.3. Advice for firefightersIn case of fire: Wear self-contained breathing apparatus.Additional informationCollect contaminated fire extinguishing water separately. Do not allow entering drains or surface water.6.1. Personal precautions, protective equipment and emergency proceduresPersonal protection equipment: see section 8. Provide adequate ventilation. (Technical ventilation ofworkplace)6.2. Environmental precautionsDo not allow to enter into surface water or drains.6.3. Methods and material for containment and cleaning upAbsorb with liquid-binding material (sand, diatomaceous earth, acid- or universal binding agents). Treat the recovered material as prescribed in the section on waste disposal.6.4. Reference to other sectionsSafe handling: see section 7Personal protection equipment: see section 8Disposal: see section 137.1. Precautions for safe handlingAdvice on safe handlingWhen handling observe the usual precautionary measures for chemicals. Avoid contact with skin and eyes.Advice on protection against fire and explosionNo special fire protection measures are necessary.Further information on handlingIn all workplaces or parts of the plant where high concentrations of aerosols and/or vapors may be generated(e.g. during pressure release, mold venting or when cleaning mixing heads with an air blast), appropriatelylocated exhaust ventilation must be provided in such a way that the OEL is not exceeded. The air should be drawn away from the personnel handling the product. The efficiency of the exhaust equipment should beperiodically checked. Take precautionary measures against static discharges.7.2. Conditions for safe storage, including any incompatibilitiesKeep container tightly closed. Storage temperature regarding personal safety: max. 40 °C. Protect from sunlight.Requirements for storage rooms and vesselsInformation about storage in one common storage facility: Keep away from: Food and feedingstuffs, Oxidising agent, strong, strong acid, Alkali (lye), concentrated Hints on joint storage7.3. Specific end use(s)Resin/Polyol components for the production of polyurethanes8.1. Control parameters Exposure limits (EH40)Category fibres/mlmg/m³ppm Substance CAS No Origin TWA (8 h)232,2'-Oxydiethanol111-46-6101WELDNEL/DMEL valuesPNEC values8.2. Exposure controlsKeep away from food and beverages. Wash hands before breaks and at the end of work. Keep work clothes separate. Take off dirty, soaked clothes immediately.Safety precautions for handling freshly molded polyurethane parts: see section 16Protective and hygiene measuresWear eye/face protection.Eye/face protectionConditionally suitable materials for protective gloves (DIN EN 374-3): Nitrile rubber: Thickness >= 0.35 mm; Breakthrough time not tested. Recommendation: Dispose of contaminated glovesThe selection of a suitable glove not only depends on the material but also on other quality features and varies from manufacturer to manufacturer. Since the product is a preparation of several substances, the resistance of glove materials is not predictable and must therefore be checked before use. Always get advice from the glove supplier.Hand protectionWear suitable protective clothing.Skin protectionUnless the product is entirely enclosed, do not handle it until you have studied the respiratory precautions issued by the appropriate authority or accident prevention association. At substantial vapor concentrations respirators must be used. Put on full-mask respirator with filter type ABEK.Respiratory protectiondifferent colours liquidPhysical state:Colour:9.1. Information on basic physical and chemical propertiescharacteristicOdour:pH-Value:not determined Changes in the physical state not determined Melting point:not determined Boiling point or initial boiling point and boiling range:not determined Flash point:Flammabilitynot applicable Solid:not applicableGas:The product is not: Explosive.Explosive propertiesnot determined Lower explosion limits:not determined Upper explosion limits:Self-ignition temperaturenot applicable Solid:not applicable Gas:not determinedDecomposition temperature:The product is not: oxidising.Oxidizing propertiesVapour pressure:not determined Density (at 22 °C):1,28 - 1,31 g/cm³Water solubility:partially miscibleSolubility in other solventsnot determined not determinedPartition coefficient n-octanol/water:Viscosity / dynamic:1.600 -2.000 mPa·s(at 22 °C)Relative vapour density:not determined Evaporation rate:not determined 9.2. Other informationSolid content:not determined10.1. ReactivityNo hazardous reaction when handled and stored according to provisions.10.2. Chemical stabilityThe product is stable under storage at normal ambient temperatures.10.3. Possibility of hazardous reactionsNo known hazardous reactions.10.4. Conditions to avoidNo information available.10.5. Incompatible materialsNo information available.10.6. Hazardous decomposition productsNo known hazardous decomposition products.11.1. Information on toxicological effectsAcute toxicityBased on available data, the classification criteria are not met.Irritation and corrosivityBased on available data, the classification criteria are not met.Sensitising effectsMay cause an allergic skin reaction. (Fatty acids, C18-unsaturated, trimers, compounds with oleylamine; Fatty acids, tall oil, compounds with oleylamine)Carcinogenic/mutagenic/toxic effects for reproductionBased on available data, the classification criteria are not met.STOT-single exposureBased on available data, the classification criteria are not met.STOT-repeated exposureBased on available data, the classification criteria are not met.Aspiration hazardBased on available data, the classification criteria are not met.12.1. ToxicityVery toxic to aquatic life.12.2. Persistence and degradability12.3. Bioaccumulative potentialThe product has not been tested.Partition coefficient n-octanol/waterLog Pow CAS NoChemical nameReaction mass of 3-methylphenyl diphenyl phosphate, 4-methylphenyl diphenyl phospha-te,4,5 bis(3-methylphenyl) phenyl phosphate, 3-methylphenyl 4-methylphenyl phenyl phosphate andtriphenyl phosphate111-46-6-1,98 2,2' -oxybisethanol, diethylene glycol1-phenoxypropan-2-ol770-35-41,41 Fatty acids, C18-unsaturated, trimers, compounds with oleylamine147900-93-4>5,7 Propylidynetrimethanol77-99-6-0,47 Fatty acids, tall oil, compounds with oleylamine85711-55-3>6,2 BCFBCFCAS NoChemical nameSourceSpeciesReaction mass of 3-methylphenyl>= 0,16Alburnus alburnus Environmental Toxico diphenyl phosphate, 4-methylphenyldiphenyl phospha-te,bis(3-methylphenyl) phenyl phosphate,3-methylphenyl 4-methylphenyl phenylphosphate and triphenyl phosphate111-46-62,2' -oxybisethanol, diethylene glycol100Leuciscus idus melanotus Chemosphere 14(10):77-99-6Propylidynetrimethanol< 1Cyprinus carpio Citation of an unavaThe product has not been tested.12.4. Mobility in soil12.5. Results of PBT and vPvB assessmentThe product has not been tested.No information available.12.6. Other adverse effectsDo not allow to enter into surface water or drains. Do not allow to enter into soil/subsoil.Further information13.1. Waste treatment methodsDisposal recommendationsDo not allow to enter into surface water or drains. Do not allow to enter into soil/subsoil.Dispose in accordance with applicable international, national and local laws, ordinances and statutes.The allocation of waste identity numbers/waste descriptions must be carried out according to the EEC, specific to the industry and process.Non-contaminated packages may be recycled. Handle contaminated packages in the same way as the substance itself. Disposal of this product, solutions and any by-products should at all times comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and nonrecyclable products via a licensed waste disposal contractor.Recycling must be done fully compliant with the requirements of all authorities with jurisdiction. No disposal to the sewer.Contaminated packagingLand transport (ADR/RID)14.1. UN number:UN 3082ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (DIPHENYL TOLYLPHOSPHATE)14.2. UN proper shipping name:914.3. Transport hazard class(es):14.4. Packing group:III Hazard label:9Classification code:M6Special Provisions:274 335 375 601Limited quantity: 5 L Excepted quantity:E1Transport category:390Hazard No:Tunnel restriction code:-Inland waterways transport (ADN)14.1. UN number:UN 308214.2. UN proper shipping name:ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (DIPHENYL TOLYLPHOSPHATE)14.3. Transport hazard class(es):914.4. Packing group:III Hazard label:9Classification code:M6Special Provisions:274 335 375 601Limited quantity: 5 LExcepted quantity:E1Marine transport (IMDG)14.1. UN number:UN 3082ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S.14.2. UN proper shipping name:(DIPHENYL TOLYLPHOSPHATE)14.3. Transport hazard class(es):914.4. Packing group:IIIHazard label:9Special Provisions:274, 335, 969Limited quantity: 5 LExcepted quantity:E1EmS:F-A, S-FAir transport (ICAO-TI/IATA-DGR)14.1. UN number:UN 3082ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S.14.2. UN proper shipping name:(DIPHENYL TOLYLPHOSPHATE)914.3. Transport hazard class(es):III14.4. Packing group:Hazard label:9Special Provisions:A97 A158 A197 A215Limited quantity Passenger:30 kg GPassenger LQ:Y964Excepted quantity:E1IATA-packing instructions - Passenger:964IATA-max. quantity - Passenger:450 LIATA-packing instructions - Cargo:964IATA-max. quantity - Cargo:450 L14.5. Environmental hazardsENVIRONMENTALLY HAZARDOUS:YesDanger releasing substance:DIPHENYL TOLYLPHOSPHATE14.6. Special precautions for userNo information available.14.7. Transport in bulk according to Annex II of Marpol and the IBC Codenot applicable15.1. Safety, health and environmental regulations/legislation specific for the substance or mixtureEU regulatory informationRestrictions on use (REACH, annex XVII):Entry 30,186 % (2,381 g/l)2010/75/EU (VOC):4,129 % (52,857 g/l)2004/42/EC (VOC):Information according to 2012/18/EU (SEVESO III):E1 Hazardous to the Aquatic EnvironmentNational regulatory informationObserve restrictions to employment for juveniles according to the 'juvenile work protection guideline' (94/33/EC). Observe employment restrictions under the Maternity Protection Directive (92/85/EEC) for expectant or nursing mothers.Employment restrictions:2 - obviously hazardous to waterWater hazard class (D):Causes allergic hypersensitivity reactions.Skin resorption/Sensitization:15.2. Chemical safety assessmentChemical safety assessments for substances in this mixture were not carried out.ChangesThis data sheet contains changes from the previous version in section(s): 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16.Abbreviations and acronymsADR: Accord européen sur le transport des marchandises dangereuses par Route(European Agreement concerning the International Carriage of Dangerous Goods by Road )IMDG: International Maritime Code for Dangerous Goods IATA: International Air Transport AssociationGHS: Globally Harmonized System of Classification and Labelling of Chemicals EINECS: European Inventory of Existing Commercial Chemical Substances ELINCS: European List of Notified Chemical Substances CAS: Chemical Abstracts Service LC50: Lethal concentration, 50%LD50: Lethal dose, 50%CLP: Classification, labelling and PackagingREACH: Registration, Evaluation and Authorization of ChemicalsGHS: Globally Harmonised System of Classification, Labelling and Packaging of Chemicals UN: United NationsDNEL: Derived No Effect LevelDMEL: Derived Minimal Effect LevelPNEC: Predicted No Effect Concentration ATE: Acute toxicity estimate LL50: Lethal loading, 50%EL50: Effect loading, 50%EC50: Effective Concentration 50%ErC50: Effective Concentration 50%, growth rate NOEC: No Observed Effect Concentration BCF: Bio-concentration factorPBT: persistent, bioaccumulative, toxicvPvB: very persistent, very bioaccumulativeRID: Regulations concerning the international carriage of dangerous goods by railADN: European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (Accord européen relatif au transport international des marchandises dangereuses par voies de navigation intérieures)EmS: Emergency Schedules MFAG: Medical First Aid GuideICAO: International Civil Aviation OrganizationMARPOL: International Convention for the Prevention of Marine Pollution from ShipsIBC: Intermediate Bulk ContainerVOC: Volatile Organic CompoundsSVHC: Substance of Very High ConcernFor abbreviations and acronyms, see table at http://abbrev.esdscom.euClassification for mixtures and used evaluation method according to Regulation (EC) No. 1272/2008 [CLP] ClassificationClassification procedureSkin Sens. 1; H317Calculation methodAquatic Acute 1; H400Calculation methodRelevant H and EUH statements (number and full text)H302Harmful if swallowed.H317May cause an allergic skin reaction.H318Causes serious eye damage.H319Causes serious eye irritation.H361Suspected of damaging fertility or the unborn child.H373May cause damage to organs through prolonged or repeated exposure.H400Very toxic to aquatic life.H411Toxic to aquatic life with long lasting effects.H412Harmful to aquatic life with long lasting effects.Further InformationSafety precautions for handling freshly molded polyurethane parts: Depending on the production parameters,any uncovered surfaces of freshly molded polyurethane parts using this raw material may contain traces ofsubstances (e. g. starting and reaction products, catalysts, release agents) with hazardous characteristics. Skin contact with traces of these substances must be avoided. Therefore, during demolding or other handling offresh molded parts, protective gloves tested according to DIN-EN 374 (e.g. nitrile rubber >= 1.3 mm thick,breakthrough time >= 480 min, or according to recommendations from glove makers thinner gloves that needto be changed in compliance with breakthrough times more frequently) must be used. Depending onformulation and processing conditions, the requirements may be different from handling of the puresubstances. Closed protective clothing is required for the protection of other areas of skin.The above information describes exclusively the safety requirements of the product and is based on ourpresent-day knowledge. The information is intended to give you advice about the safe handling of the productnamed in this safety data sheet, for storage, processing, transport and disposal. The information cannot betransferred to other products. In the case of mixing the product with other products or in the case ofprocessing, the information on this safety data sheet is not necessarily valid for the new made-up material.(The data for the hazardous ingredients were taken respectively from the last version of the sub-contractor's safetydata sheet.)。

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5、冠状动脉瘘的介入治疗
• 冠状动脉肺动脉瘘堵塞前后左冠状动脉造影
弹簧圈堵闭冠状动脉瘘
经微导管送入弹簧圈
经微导管送入0.018英寸直径弹簧圈封堵冠状动脉肺动脉瘘
coil
The fistula between CA
and pulmonary artery
6、腹主动脉肾静脉瘘的介入治疗
短暂的低血压和一过性晕厥
心律失常穿刺部位静脉损伤
2、经皮肺动脉瓣膜置入术
材料
该瓣膜来自猪颈静脉，固定于一可扩张金属支架
Bovine Jugular Valve
方法
• 经股静脉途径 • 治疗过程类似球囊成型术
临床应用
• 100例患者，平均年龄16岁（7－35） • 疾病种类：肺动脉瓣关闭不全和/或右室流出道梗阻 • 外科不能手术者4例胸部畸形 2 肺血管疾病 2 • 38% NYHA 3或4级 • 下肢途径95例，颈静脉途径5% • 成功率100%； • 无死亡，随访5年
←下腔静脉
腹主动脉肾静脉瘘封堵前后
←肾静脉
主动脉封堵前
←封堵后
←主动脉
7、先天性肺动静脉瘘的介入治疗
8、动脉瘤介入治疗
• 植入带膜的血管支架
带分支覆膜支架治疗裂口位于大血管分支附近的夹层动脉瘤
约5%-10%夹层动脉瘤裂口距锁骨下动脉1.5cm 安全距离
带分支支架，可免除颈部附加手术
可行介入治疗的先心病
• • • • • • • 肺动脉瓣狭窄主动脉瓣狭窄血管狭窄(肺动脉狭窄等) 动、静脉瘘动脉导管未闭继发孔型房间隔缺损肌部室间隔缺损、膜部室间隔缺损。
1990-2004年间国内先心病介入治疗例数的变化趋势图
例数 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 0
方法
作用机制
• 动脉粥样斑块的挤压,破裂; • 冠脉内膜的的裂开和撕裂,使管腔扩大; • 冠脉血管壁的向外延伸和改型
PTCA术后血管内超声
适应证(临床):
• 急性心肌梗死 • 陈旧性心肌梗死 • 心绞痛
适应证(病变)：
• 冠心病(心绞痛,心肌梗血栓死) 单支血管病变多支血管病变 1 左主干病变 • 冠状动脉搭桥术后血管桥狭窄 • 乳内动脉狭窄
并发症
同心导管检查少数患者术后出现溶血
2、房间隔缺损封堵术
房间隔缺损分型：
中央型上腔型下腔型混合型
Sideris房缺封堵法
螺旋型房间隔缺损封堵器
Amplatzer法
• ： •
Device 0.004-0.0075” Nitinol Two Flat Disks 4mm Waist Sizes: 4-38 mm Delivery Cable: 7-12F
SVC
RA AO
IVC
CS
TV
多普勒超声测量房间隔缺损直径
LA IVC RA RV LA SVC
LV RA
•箭头处为房间隔缺损部位
Transcatheter Closure of ASD Using AmplatzerTM Device
并发症及其处理
• • • • 扩张段血管的急性闭塞: 冠脉内注射硝酸甘油200-300ug, 再次球囊扩张血管内支架
边支闭塞:
• 边支大者应将导丝送入边支再用球囊扩张。
侧枝闭塞
冠脉穿孔或破裂:
• 立即放置带膜支架 • 急诊冠状动脉搭桥
右室穿孔和心包积血:
• 常因放置右室起搏导管所致 . 需要立即外科治疗。
经冠状窦二尖瓣成型术
• 冠状窦是位于房室沟的大静脉,与二尖瓣环后部接近和平行,在冠状窦内放置成型环有可能减小二尖瓣环隔侧和侧侧的直径,增加二尖瓣叶的对合,因此减少二尖瓣返流.
•
三、先心病介入治疗
• • • •
全国每年新生儿中先心病约为15万。继发孔型房间隔缺损占7～10％。动脉导管未闭占26.4%。单纯室缺占20 ％
操作程序 • 穿刺右股静脉、股动脉。
穿刺房间隔
术后处理
同右心导管检查。口服阿斯匹林300mg/日
并发症及其防治
•室性心律失常 •心壁穿孔及心包填塞。 •急性肺水肿。 •二尖瓣返流。
二尖瓣叶撕裂心房水平的左向右分流血栓栓塞其他一过性脑缺血，心动过缓等
4.主动脉瓣狭窄
主动脉瓣狭窄病理改变
mm
纤维帽
脂核
右冠状动脉病变
完全闭塞病变
血管分叉处病变的Pቤተ መጻሕፍቲ ባይዱCA
左主干病变
不稳定型心绞痛(UAP)
•
急性心肌梗死的介入治疗
急性心肌梗死急诊PTCA
6 小时内 , 较溶栓治疗疗效好、快、残存狭窄轻,无纤溶的副作用
AMI补救性(rescue)PTCA
• 急性心梗早期溶栓失败而仍有明显胸痛及ST段明显异常者
胎儿主动脉瓣狭窄的介入治疗
胎儿主动脉瓣狭窄的介入治疗
经皮主动脉瓣植入术
1994年开始
经皮主动脉瓣植入术
经皮主动脉瓣膜置入术
经皮主动脉瓣植入术
经皮主动脉瓣膜置入术
经皮置换主动脉瓣膜－逆行法
• 2005TCT资料：患者术后2年仍健在
5、经皮二尖瓣成形术
经导管边－边缝合修复术
经导管边－边缝合修补术
• 模拟外科手术的边－边缝合修补术
材料
－缝合夹
• 穿刺房间隔 • X透视和超声引导方法 • 在心室收缩末夹合
边－边缝合系统
边－边缝合
EVEREST1:Endovascular Valve Edge-toEdge Repair Study • 入选50例 • 6例夹合未成功－外科治疗 • 夹合成功44例 3例返流未减少－外科治疗 4例夹子脱位－外科治疗 • 无死亡、致残 • 基本上不影响外科治疗 • 其余37例正在观察随访中
例数
1990
1992
1994
1996
1998
2000
2002
2004
1、动脉导管未闭堵塞术
未闭动脉导管分型
• • • • • 管型漏斗型窗型哑铃型动脉瘤型
• Amplatzer 法：98年应用于临床。损伤小，操作方便，使用安全，全球已治疗1万例。 • 弹簧圈－适用于PDA内径＜3mm者，残余分流发生率高，并伴溶血，易脱落。但价格低。

PS同时并有可介入治疗的其它
心脏畸形

外科手术后或PBPV后再狭窄者
禁忌证
严重肺血管发育不良
瓣膜上有赘生物
有普通心导管检查禁忌症者
（过敏﹑感染﹑出血等）
球囊导管－Inoue
球囊
聚乙烯球囊导管
单球囊扩张
双球囊扩张
Inoue 球囊扩张
肺动脉瓣膜狭窄球囊扩张术
肺动脉瓣狭窄球囊扩张前后
操作方法－重复造影及测压
并发症
移植瓣破裂移植瓣狭窄移植瓣移位感染性心内膜炎 1 9 2 2
3、经皮球囊二尖瓣成形术
• 机理通过球囊充盈产生的张力，使瓣膜粘连的交界区裂开
1984年，日本医生Inoue(井上宽治)。最先报道了PBMV的临床应用经验
适应症
• 单纯二尖瓣狭窄,MVA≤1.5cm2 , 无二尖瓣关闭不全或伴有轻度二尖瓣关闭不全 ,或轻度主动脉瓣关闭不全。 • 心功能Ⅱ-Ⅲ级(NYHA)。 • 无风湿活动。 • 窦性心律或房颤经抗凝治疗2月以上者。 • 超声波检查二尖瓣无钙化,瓣下结构基本正常。 • 外科二尖瓣分离术后再狭窄。
其他:
• • • • 血肿心律失常造影剂反应急性、亚急性血栓－抗凝、抗血小板治疗、介入溶栓 • 再狭窄－－球囊扩张、药物支架，外科搭桥
• 在PTCA基础上发展的其他冠脉介入治疗技术
冠状动脉内支架植入术
• 旋切术
旋切术
旋磨术
激光冠状动脉成形术
PTCA、支架术后再狭窄
• 发生率20－50％ • 药物涂层支架的应用再狭窄降低至 10％以下。
AMI择期PTCA
• 溶栓成功的病人可在3－4周后行常规冠状动脉造影，对严重狭窄病变行PTCA
PTCA的禁忌症
• 未被保护的左主干病变 • 慢性完全阻塞性病变(>3月) • 弥漫性病变
术后处理
• 在CCU 监护 24 小时,并保证插管部位适当止血 • 抗血小板药物的应用阿司匹林－－－治疗1年波立维－－－9月 • 抗凝治疗 3－5天 • 冠心病治疗
疗效评价
• 心绞痛－－疗效可靠 • 急性心肌梗死疗效与介入的时间有关。时间就是心肌,时间就
是生命。AMI治疗的关键是尽早开通闭塞冠脉,最大限度地挽救濒死心肌,缩小梗死面积,从而改善患者的远期预后。
• Stukel等在JAMA上发表了一项美国不同地区急性心梗(AMI)老年患者接受药物治疗和有创介入治疗对长期临床转归影响的研究结果，发现无论该地区介入治疗水平如何,更为积极的药物治疗模式可使患者生存率得到提高,但在药物治疗强度较高的地区,更多的介入治疗,较少或未能带来生存率的改善。
二、瓣膜病的介入治疗
• 瓣膜狭窄 • 瓣膜关闭不全
1、肺动脉瓣球囊成型术

发病率占先天性心脏病
的 8-10%

男女性别之比为 3：2
病理解剖特点
瓣膜狭窄占93.7%
漏斗部狭窄占 1.7%
其它占4.6%
病理解剖特点
瓣缘的融合形成圆顶样的结构三叶瓣或两叶瓣或四叶瓣随年龄增长瓣叶增厚、僵硬、钙化，瓣口偏向一边
适应证
• 中央型房间隔缺损,缺口边缘有5mm的房间隔组织,边缘离冠状窦和肺静脉5mm以上者
心尖四腔心和剑下两房心切面