IEC60601-1_2005 Overview

IEC60601-1:2005 An Overview
Medical electrical equipmentPart 1:General requirements for basic safety and essential performance


Why have Standards?
Standards are considered to be a known method to determine minimum levels of safety Standards bring a consistency and repeatability to testing Standards are “consensus” documents
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Why have Standards (cont.)?
Increases marketability of your product Increases market acceptance of your product via: • Wide acceptance of national test agencies (CB scheme) • Fewer “national” tests means your product gets to market quicker (competitive advantage) • May provide support with legal issues
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A Sample of “601” National Standards
Australia / New Zealand: AS/NZS 3200-1-0 Canada: CAN/CSA C22.2 No. 601.1 EU Countries: EN 60601-1 Japan: JIS T-0601-1 Korea: Based on IEC 60601-1 Unites States: UL 60601-1
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History of IEC60601-1
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IEC60601-1 Series
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IEC 60601-1
2-21 2-20 2-19 2-18 2-17 2-16 2-15 2-14 2-13 2-12 2-11 2-10
2-26 2-25 2-24 2-23 2-22
2-27
2-28
2-33 2-34 2-35 2-36
60601-1-4
Software
60601-1-6
Usability
2-37 2-38 2-39 2-40 2-41 2-42 2-43 2-44 2-45 2-46
60601-1-3
Radiation
60601-1-8
Alarms
60601-1 MEE
60601-1-2
EMC
Environment
60601-1-9
60601-1-10
Controllers
2-47 2-48 2-49 2-50 2-51 2-52
60601-1-1
Systems
60601-1-11
Home Care
2-09 2-08 2-07 2-06 2-05 2-04
Collateral Standards
2-53 2-54 2-55 2-03 2-02 2-57 2-01 2-59 2-58 2-56
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Particular Standards


Various Country Requirements - the EU
Medical devices must comply with the European Medical Device Directive (93/42/EEC) The MDD outlines “essential requirements” Risk analysis is needed (ISO 14971)
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Various Country Requirements - the US
Medical devices must be “safe and effective” (FDA) The FDA “accepts” compliance to various safety standards, such as IEC 60601. Risk analysis is needed as a part of design validation (QSR: 21CFR 820.30g))
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Various Country Requirements - Canada
Medical devices must be “safe and effective” (Health Canada) Health Canada “accepts” compliance to various safety standards, such as CAN/CSA C22.2 No. 601.1 (Basically the same as IEC 60601) Risk analysis is needed
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Various Country Requirements –Asia, South America, Eastern Europe
9Medical devices must be “safe”
9Many countries “accept”compliance to IEC 60601-1 and many have written standards based on this document
9Risk analysis is becoming required in more countries
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Why the Third Edition?
-IEC Standard revision practices 9Amendent 1，Nov-19919Amendent 2，March-1995
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Introduction to the 3rd Edition
9The first major change is the Introduction of the concept for Essential Performance
9The risk management philosophy is the most significant change to the standard.
9Compliance with 3rd edition is possible only if the manufacturer has a risk management process complying with ISO 14971.
9Risk Management File must be submitted with type testing
IEC 60601-2-43: Interventional X-ray
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Clause 3.27 Essential Performance
¾Performance necessary to achieve freedom from unacceptable risk
Note: ESSENTIAL PERFORMANCE is most easily understood by considering whether its absence or degradation would result in an
unacceptable RISK.
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Risk Management
ISO 14971: Medical Devices —Risk
Management —Application of Risk Management to Medical Devices
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Hazard 危害
损害的潜在源
Potential source of harm
Harm 损害
对人健康的实际伤害或侵害，或对财产或环境的侵害。

Physical injury or damage to the health of people, or damage to property or the environment
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Risk 风险(Mentioned over 700 times):
损害（Harm ）的发生概率和损害严重程度的结合
combination of the probability of occurrence of harm and the severity of that harm
Hazard Situation 危害情形
‐人员、财产或者环境处于一个或者多个危害的的境遇
‐circumstance in which people, property, or the environment are exposed to one or more hazard's)
在新版ISO 14971:2007 中、美国食品药品管理局和美国医疗器材促进会（AAMI ）的指南中都有规定危害情形指出现危害，不论是否因该危害事件造成了危害后果,这以危险前提具备的程度而定。

Risk analysis 风险分析
‐系统利用所得资料判定危害并估计风险
‐systematic use of available information to identify hazards and to estimate the risk
Risk management 风险管理
‐用于风险分析、评价和控制工作的管理方针、程序及其实践的具体应用。

‐systematic application of management policies, procedures and practices to the tasks of analysing, evaluating,
controlling and monitoring risk;
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What is Risk Management ?
9We don’t mean managing business risk
9We mean systematically applying management policies, procedures, and practices to minimizing risks from medical devices
9That is: analyzing, evaluating, and controlling risks in a systematic way
-Worldwide standard for managing risk -Management (Process) Standard -Total Lifecycle standard
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What is the purpose of ISO 14971?ISO 14971 is intended to provide a common framework for the identification, analysis and control of all risks arising from medical devices.
As a total life-cycle standard, the purpose of risk management according to ISO 14971 is to improve the safety of medical devices as technology advances.
ISO 14971 provides a framework for identifying & controlling risks outside of the well known electrical/mechanical risks.
Condition and Harm
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Risk management
process
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What does ISO 14971 require?Risk Analysis
9
Based on intended use and reasonably foreseeable misuse 9Identify all characteristics that could affect the
safety of the medical device and where
appropriate, defined limits
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Identify all known and reasonably foreseeable hazards in normal and fault conditions
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What does ISO 14971 require?Examples:
-Normal Condition & Use, Reasonably foreseeable misuse, Fault Conditions, Direct and indirect harm conditions
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What does ISO 14971 require?
Risk Analysis continued
-Estimate the risks using available information or data (e.g. published standards, clinical evidence,
field/scientific data)
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What does ISO 14971 require?
Risk Analysis continued
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Risk Evaluation
Based on established criteria, determine if all
identified risks require mitigation (reduction)
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Where required, risks are controlled
(1) through design (eliminate the risk),
(2) through protective measures (guards, control exposure), or
(3) through information for safety (warnings, labeling)
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Risk Control continued
9Risk controls are implemented, the implementation and it’s effectiveness are verified
9Residual risk is evaluated to determine if further risk mitigation is required
9Cycle continues until risk is acceptable or no further mitigation is feasible and a risk/benefit
analysis is performed to determine if the benefits of use outweigh the risks of the device
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GE /Risk Control continued
9Risk controls reviewed to determine if any new risks have been created
9Manufacturer must ensure all risks have been considered
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Residual Risk Evaluation
9Review of the overall risk of the device is required to determine if the overall risk (sum of all individual risks) of the medical device is acceptable.
9For products where individual risks or the overall residual risk is judged to be unacceptable according to the manufacturers policy, a risk benefit analysis can be performed to determine if the benefit of using the device (substantially) outweighs the risk(s).
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Production & Post Production
Manufacturers are required to institute monitoring during production and post production to continually monitor for:
-new risks
-accuracy of initial risk analysis (probability & severity)
-changes in acceptability
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GE /Equipment Classification
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GE /Equipment Classifications
9Electric Shock
9IP (water or particulate matter)
9Methods of Sterilization
9Suitability in oxygen environment
9Mode of Operation
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GE /Classification of Electric Shock
9Class I –One (of two) MOP is PE
9Class II –Two MOP (Neither is PE)
9Internally Powered
9
Type B Applied part 9Type BF Applied part 9Type CF Applied part
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Classification: Sterilization, Oxygen&Mode of Operation
9Sterilization (if intended) –methods needs to be in the IFU
9Oxygen (if intended) –details need to be in the IFU
9Mode of Operation –device without marking are assumed continuous
-Continuous Operation
-Duty cycle (Non –Continuous Operation)
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Electric Shock Hazards
9An electric shock occurs when electric current flows through the body.
9Some medical devices intentionally pass an electric current to a patient (e.g. Defibrillators)9Limits on current flow are provided in the medical standards.
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Protection Against Electrical Hazard The fundamental principle for protection against electric shock is that the voltage or current between any accessible surface and any other accessible surface or earth is low enough not to present a HAZARD, in all relevant circumstances including NORMAL CONDITION and SINGLE FAULE CONDITION.
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GE /Unintended Current = Leakage Current LEAKAGE CURRENT:Current that is not functional. (IEC 60601 has definitions for the following: EARTH LEAKAGE CURRENT, TOUCH CURRENT and PATIENT LEAKAGE CURRENT.)
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Leakage Current
2nd Edition: 0.5 mA NC, 1 mA SFC.
3rd Edition: 5 mA NC, 10 mA SFC.
9Positive: Manufacturers will be able to use IEC 60950-1Power supplies and line filters which will save money.9Negative: This can be help with only if all accessible parts isolate from PE
9Concept of total patient leakage current added
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Insulation
¾Means of protection (mop): Means for reducing the risk due to electric shock in accordance with the requirements of this standard (include insulation, air clearance, creepage distances…)
¾The means of protection for the patient is named as MOPP (Means Of Patient Protection)
¾The means of protection for the Operator is named as MOOP (Means Of Operator Protection)
¾Protection againest electric shock in general is:-Either two MOO(P)PS
-Or one MOO(P)Ps and a protectively earthed part
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50/GE /8.9.1.9 Overvoltage category classification The applicable value of the MAINS TRANSIENT VOLTAGE shall be determined from the overvoltage category according to IEC 60664-1 and the NOMINAL a.c. MAINS VOLTAGE using Table 10.。