IEC 60601-1-2005 Medical electrical equipment - Part 1 General requirements for basic safety and essential performance《医用电气设备.第1部分 基本安全和基本性能的一般要求》.pdf

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1、IEC 60601-1Edition 3.0 2005-12INTERNATIONALSTANDARDNORMEINTERNATIONALEMedical electrical equipment Part 1: General requirements for basic safety and essential performance Appareils lectromdicaux Partie 1: Exigences gnrales pour la scurit de base et les performances essentielles IEC60601-1:2005 THIS

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16、z-nous:Email: csciec.chTl.: +41 22 919 02 11 Fax: +41 22 919 03 00 IEC 60601-1Edition 3.0 2005-12INTERNATIONAL STANDARD NORME INTERNATIONALEMedical electrical equipment Part 1: General requirements for basic safety and essential performance Appareils lectromdicaux Partie 1: Exigences gnrales pour la

17、 scurit de base et les performances essentielles INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XHICS 11.040 PRICE CODECODE PRIXISBN 2-8318-8400-4April 2008 Publication IEC 60601-1 (Third edition 2005) I-SH 01 MEDICAL ELECTRICAL EQUIPMENT Part 1: General require

18、ments for basic safety and essential performance INTERPRETATION SHEET 1 This interpretation sheet has been prepared by SC 62A: Common aspects of electrical equipment used in medical practice The text of this interpretation sheet is based on the following documents: ISH Report on voting 62A/599/ISH 6

19、2A/613/RVDFull information on the voting for the approval of this interpretation sheet can be found in the report on voting indicated in the above table. _ Subclause 1.1 This subclause is clarified by the following: IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Me

20、dical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum. NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm signals. This clarification will remain valid until a new version of IEC 60601-1 is published. _ 1 Ja

21、nuary 2009 ICS 11.040 French text overleaf Publication IEC 60601-1 (Third edition 2005) I-SH 02 MEDICAL ELECTRICAL EQUIPMENT Part 1: General requirements for basic safety and essential performance INTERPRETATION SHEET 2 This interpretation sheet has been prepared by subcomittee 62A: Common aspects o

22、f electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. The text of this interpretation sheet is based on the following documents: ISH Report on voting 62A/634/ISH 62A/640/RVDFull information on the voting for the approval of this int

23、erpretation sheet can be found in the report on voting indicated in the above table. _ Subclause 11.3 This subclause is clarified by the following: As stated in the rationale for this subclause, fire ENCLOSURES are intended to be used only where there is a significant likelihood of fire due to the p

24、resence of a source of ignition (as described in the subclause) and a significant source of fuel. Most materials used in the construction of ME EQUIPMENT are not considered to be such a source of fuel unless they are in the presence of an OXYGEN RICH ENVIRONMENT. MANUFACTURERS should determine, thro

25、ugh analyses documented in the RISK MANAGEMENT FILE, whether the ME EQUIPMENT contains combustible materials (fuel) in sufficient quantities to support combustion in conjunction with ignition sources (capable of releasing greater than 900 J). Subclause 13.1.2 This subclause is clarified by the follo

26、wing: As stated in subclause 4.7, it is the MANUFACTURERS RISK ANALYSIS that determines which components are subject to failure testing based on the associated RISK. Where the associated RISK of fire exceeds the MANUFACTURERS criteria for RISK acceptability, the MANUFACTURERS simulation analysis (su

27、ch as FMEAs) should be accepted in lieu of physical testing. As also stated in 4.7, component reliability and ratings are to be considered in such failure simulation analyses. Common electronic components that have a history of use without causing equipment fires should not be considered a likely so

28、urce of ignition. Where the subclause identifies “emission of flames, molten metal, poisonous or ignitable substance in hazardous quantities;” as a hazardous situation, this refers to emissions from the ENCLOSURE not from components themselves. Where it identifies “exceeding the allowable values for

29、 other components and materials identified in Table 22 times 1,5 minus 12,5 C”, this applies only where doing so would result in an unacceptable RISK (as identified in the MANUFACTURERS RISK ANALYSIS according to 4.7). Typically, this would be cases where 2 January 2009 ICS 11.040 French text overle

30、af ESSENTIAL PERFORMANCE would not be maintained or where greater than 900 J of energy would be released in the presence of flammable materials that could sustain combustion. The first exemption to fault analysis or testing identified in subclause 13.1.2 (“The construction or the supply circuit limi

31、ts the power dissipation in SINGLE FAULT CONDITION to less than 15 W or the energy dissipation to less than 900 J.”) is intended to apply where the component design itself (“The construction”) or fusing (or other current limiting devices) in the supply circuit (“or the supply circuit”) assure the en

32、ergy released during failures will not exceed the limits. For most common signal level components rated for operation below 5 Watts, the energy released by short-circuiting of outputs will not exceed the 900 J limit. This clarification will remain valid until a new version of IEC 60601-1 is publishe

33、d. _ May 2013 ICS 11.040 French text overleaf SC 62A/Publication IEC 60601-1:2005, including Amendment 1:2012, Third edition/I-SH 03 MEDICAL ELECTRICAL EQUIPMENT Part 1: General requirements for basic safety and essential performance INTERPRETATION SHEET 3 This interpretation sheet has been prepared

34、 by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. The text of this interpretation sheet is based on the following documents: ISH Report on voting 62A/858/ISH 62A/875/RVD Full information on

35、the voting for the approval of this interpretation sheet can be found in the report on voting indicated in the above table. _ Subclause 13.1.2 fourth dash (Emissions, deformation of ENCLOSURE or exceeding maximum temperature) This subclause states the following: The following HAZARDOUS SITUATIONS sh

36、all not occur: . temperatures of ME EQUIPMENT parts that are not APPLIED PARTS but are likely to be touched, exceeding the allowable values in Table 23 when measured and adjusted as described in 11.1.3; This is clarified by the following: The above requirement is regarded as fulfilled in accordance

37、with Subclause 4.5 for temperatures at the surfaces of the enclosure, if the following conditions are fulfilled: The maximum allowed temperature on OPERATOR accessible surfaces in SINGLE FAULT CONDITION is 105 C; and the instructions for use contain a warning that, under some SINGLE FAULT CONDITIONS

38、, the temperature of: (indicate the surface of concern) could get hot and there is a possible RISK of a burn if touched, and if the RISK ANALYSIS demonstrates a need for a warning symbol on the ENCLOSURE, safety sign ISO 7010-W018 ( ) shall be used on or adjacent to the hot spot on the ENCLOSURE; an

39、d the RISK ASSESSMENT demonstrates that the temperature attained in the SINGLE FAULT CONDITION is acceptable, and the RISK ASSESSMENT demonstrates that applying the alternative RISK CONTROL measures in this Interpretation Sheet results in a RESIDUAL RISK that is comparable to the RESIDUAL RISK resul

40、ting from applying the requirement of the standard. NOTE 1 This Interpretation Sheet is intended to be used with both Edition 3.0 and Edition 3.1 of IEC 60601-1. NOTE 2 An example of an analysis that demonstrates an adequately low probability of occurrence of HARM is shown below. May 2013 ICS 11.040

41、 French text overleaf Example RISK ASSESSMENT: The sum failure rate for parts that could increase the surface temperature of parts of the enclosure of XYZ device touchable only by the OPERATOR to values above those of Table 23 calculates to be 60 FIT (1 FIT = 1E-9/h) according to the standard MIL-HD

42、BK-217F where FIT stands for “failure in time“. In case of such failures, the device would emit an odour and would no longer function properly. It is estimated, that only in one of 3 cases the device would not be switched off immediately and the hot surface would be resulting in a burn. The resultin

43、g overall probability of such HARM where adequate warning is provided in the instructions for use in combination with warning sign ISO 7010 W018 would be: probability = 1/3 * 60 FIT = 2 E-8/h =approx. 0,0002 per year. In this example, the WXW Companys RISK acceptance criteria require that a HARM of

44、that severity must have a probability of less than 0,0003 per year for the associated RISK to be considered acceptable. Based on that RISK acceptance criterion, the RISK associated with overtemperature of the ENCLOSURE caused by single faults in the circuitry is acceptable. 60601-1 IEC:2005 3 CONTEN

45、TS FOREWORD.11INTRODUCTION.131 Scope, object and related standards.151.1 * Scope .151.2 Object .151.3 * Collateral standards151.4 * Particular standards162 * Normative references.163 * Terminology and definitions .204 General requirements.404.1 * Conditions for application to ME EQUIPMENT or ME SYST

46、EMS404.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS 404.3 * ESSENTIAL PERFORMANCE .414.4 * EXPECTED SERVICE LIFE414.5 * Equivalent safety for ME EQUIPMENT or ME SYSTEMS .424.6 * MEEQUIPMENTor ME SYSTEM parts that contact the PATIENT .424.7 * SINGLE FAULT CONDITION for ME EQUIPMENT.424.

47、8 Components of ME EQUIPMENT .434.9 * Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT .434.10 * Power supply 444.11 Power input .455 * General requirements for testing ME EQUIPMENT .465.1 * TYPE TESTS465.2 * Number of samples .465.3 Ambient temperature, humidity, atmospheric pr

48、essure.465.4 Other conditions 465.5 Supply voltages, type of current, nature of supply, frequency 475.6 Repairs and modifications .475.7 * Humidity preconditioning treatment .475.8 Sequence of tests .485.9 * Determination of APPLIED PARTS and ACCESSIBLE PARTS .486 * Classification of ME EQUIPMENT an

49、d ME SYSTEMS.506.1 General .506.2 * Protection against electric shock.506.3 * Protection against harmful ingress of water or particulate matter 516.4 Method(s) of sterilization . 516.5 Suitability for use in an OXYGEN RICH ENVIRONMENT 516.6 * Mode of operation. 51 2 60601-1 IEC:200560601-1 IEC:2005 5 7MEEQUIPMENTidentification, marking and documents .517.1 General .517.2