EN 62353-2014 en Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment.pdf

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1、BSI Standards PublicationMedical electrical equipment Recurrent test and test after repair of medical electrical equipmentBS EN 62353:2014BS EN 62353:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 62353:2014. It is identical to IEC 62353:2014. It supersede

2、s BS EN 62353:2008, which will be withdrawn on 9 October 2017.The UK committee voted against the first edition of this standard, however, the issues raised previously have now been resolved in this edition.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical

3、 Equipment in Medical Practice, to Subcommittee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a

4、 contract. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014ISBN 978 0 580 76289 5ICS 11.040.01Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under t

5、he authority of the Standards Policy and Strategy Committee on 31 December 2014.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 62353 October 2014 ICS 11.040 Supersedes EN 62353:2008 English Version Medical electrical equipment - R

6、ecurrent test and test after repair of medical electrical equipment (IEC 62353:2014) Appareils lectromdicaux - Essai rcurrent et essai aprs rparation dun appareil lectromdical (CEI 62353:2014) Medizinische elektrische Gerte - Wiederholungsprfungen und Prfung nach Instandsetzung von medizinischen ele

7、ktrischen Gerten (IEC 62353:2014) This European Standard was approved by CENELEC on 2014-10-09. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-

8、to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by tr

9、anslation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic

10、, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Euro

11、pean Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwid

12、e for CENELEC Members. Ref. No. EN 62353:2014 E BS EN 62353:2014EN 62353:2014 - 2 - Foreword The text of document 62A/942/FDIS, future edition 2 of IEC 62353 prepared by SC 62A “Common aspects of electrical equipment used in medical practice“ of IEC/TC 62 “Electrical equipment in medical practice“ w

13、as submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62353:2014. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2015-07-09 latest date by which th

14、e national standards conflicting with the document have to be withdrawn (dow) 2017-10-09 This document supersedes EN 62353:2008. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or CEN shall not be held responsible for

15、identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 62353:2014 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IE

16、C 60335 Series NOTE Harmonized as EN 60335 Series. IEC 60950 Series NOTE Harmonized as EN 60950 Series. IEC 60950-1 NOTE Harmonized as EN 60950-1. IEC 61010 Series NOTE Harmonized as EN 61010 Series. IEC 61557-2:2007 NOTE Harmonized as EN 61557-2:2007 (not modified). IEC 61557-4:2007 NOTE Harmonized

17、 as EN 61557-4:2007 (not modified). IEC 61557-16 1)NOTE Harmonized as EN 61557-16 1)(not modified). IEC 62020 NOTE Harmonized as EN 62020. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012 (not modified). ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012 (not modified). IEC 60364-7-710 NOTE Harm

18、onized as HD 60364-7-710. IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010. 1)To be published. BS EN 62353:2014EN 62353:2014 - 2 - Foreword The text of document 62A/942/FDIS, future edition 2 of IEC 62353 prepared by SC 62A “Common aspects of electrical equipment used in medical practice“ of IEC/TC

19、 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 62353:2014. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endo

20、rsement (dop) 2015-07-09 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2017-10-09 This document supersedes EN 62353:2008. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENEL

21、EC and/or CEN shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 62353:2014 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes

22、have to be added for the standards indicated: IEC 60335 Series NOTE Harmonized as EN 60335 Series. IEC 60950 Series NOTE Harmonized as EN 60950 Series. IEC 60950-1 NOTE Harmonized as EN 60950-1. IEC 61010 Series NOTE Harmonized as EN 61010 Series. IEC 61557-2:2007 NOTE Harmonized as EN 61557-2:2007

23、(not modified). IEC 61557-4:2007 NOTE Harmonized as EN 61557-4:2007 (not modified). IEC 61557-16 1)NOTE Harmonized as EN 61557-16 1)(not modified). IEC 62020 NOTE Harmonized as EN 62020. ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2012 (not modified). ISO 14971:2007 NOTE Harmonized as EN ISO 1497

24、1:2012 (not modified). IEC 60364-7-710 NOTE Harmonized as HD 60364-7-710. IEC 61010-2-010 NOTE Harmonized as EN 61010-2-010. 1)To be published. BS EN 62353:2014- 3 - EN 62353:2014 Annex ZA (normative) Normative references to international publications with their corresponding European publications T

25、he following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 W

26、hen an International Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu Publication Year Title EN/HD Year IEC 6041

27、7-DB - Graphical symbols for use on equipment - - IEC 60601-1 + A1 + A2 1988 1991 1995 Medical electrical equipment - Part 1: General requirements for safety EN 60601-1 + corr. July + A1 + A1/corr. July + A2 1990 1994 1993 1994 1995 IEC 60601-1 +A1 2005 2012 Medical electrical equipment - Part 1: Ge

28、neral requirements for basic safety and essential performance EN 60601-1 + corr. March + corr. May + A1 + A1/corr. July 2006 2010 2014 2013 2014 IEC 61010-1 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements EN 61010-1 - IEC 6101

29、0-031 - Safety requirements for electrical equipment for measurement, control and laboratory use - Part 031: Safety requirements for hand-held probe assemblies for electrical measurement and test EN 61010-031 - IEC 61140 - Protection against electric shock - Common aspects for installation and equip

30、ment EN 61140 - IEC 61557-1 - Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. - Equipment for testing, measuring or monitoring of protective measures - Part 1: General requirements EN 61557-1 - BS EN 62353:2014 2 IEC 62353:2014 IEC 2014 CONTENTS 1 Scope 7 2

31、Normative references 8 3 Terms and definitions 8 4 Requirements 16 4.1 * General requirements . 16 4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR 17 4.3 * RECURRENT TEST . 18 5 * Tests . 18 5.1 General . 18 5.2 Visual INSPECTION . 18 5.3 Measurements 19 5.3.1 General

32、. 19 5.3.2 Measuring of PROTECTIVE EARTH RESISTANCE 19 * Measurement of insulation resistance (not mandatory) 21 5.3.3Leakage currents . 24 5.3.45.4 Functional test 31 6 Results of test and evaluation 31 6.1 Reporting of results. 31 6.2 Evaluation . 32 Annex A (informative) General guidance and rati

33、onale . 33 A.1 Intended audience 33 A.2 Differences between IEC 60601-1 and IEC 62353 . 34 A.3 Rationale 35 Annex B (informative) Sequence of testing 42 Annex C (normative) Requirements for the measurement equipment and for measurement circuits for PROTECTIVE EARTH RESISTANCE and leakage currents .

34、44 C.1 Requirements for the measurement equipment . 44 C.2 Measurement equipment for measurement of PROTECTIVE EARTH RESISTANCE 44 C.3 Measurement equipment for measurements of EQUIPMENT LEAKAGE CURRENT 45 C.4 Measurement equipment for measurements of APPLIED PART LEAKAGE CURRENT . 45 Annex D (infor

35、mative) PATIENT ENVIRONMENT 47 Annex E (normative) Allowable values for leakage currents from IEC 60601-1 . 48 Annex F (informative) Testing intervals 51 Annex G (informative) Example of test documentation . 52 Annex H (informative) Notes on testing ME SYSTEMS . 53 H.1 Overview 53 H.2 Guidelines for

36、 re-testing of an ME SYSTEM 53 H.3 Guidelines on ME SYSTEMS from the rationale annex of IEC 60601-1:2005 /AMD1:2012 54 H.4 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) 58 Bibliography 60 Index of defined terms 61 BS EN 62353:2014 2 IEC 62353:2014 IEC 2014 CONTENTS 1 Scope 7 2 Normative r

37、eferences 8 3 Terms and definitions 8 4 Requirements 16 4.1 * General requirements . 16 4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR 17 4.3 * RECURRENT TEST . 18 5 * Tests . 18 5.1 General . 18 5.2 Visual INSPECTION . 18 5.3 Measurements 19 5.3.1 General . 19 5.3.2

38、Measuring of PROTECTIVE EARTH RESISTANCE 19 * Measurement of insulation resistance (not mandatory) 21 5.3.3Leakage currents . 24 5.3.45.4 Functional test 31 6 Results of test and evaluation 31 6.1 Reporting of results. 31 6.2 Evaluation . 32 Annex A (informative) General guidance and rationale . 33

39、A.1 Intended audience 33 A.2 Differences between IEC 60601-1 and IEC 62353 . 34 A.3 Rationale 35 Annex B (informative) Sequence of testing 42 Annex C (normative) Requirements for the measurement equipment and for measurement circuits for PROTECTIVE EARTH RESISTANCE and leakage currents . 44 C.1 Requ

40、irements for the measurement equipment . 44 C.2 Measurement equipment for measurement of PROTECTIVE EARTH RESISTANCE 44 C.3 Measurement equipment for measurements of EQUIPMENT LEAKAGE CURRENT 45 C.4 Measurement equipment for measurements of APPLIED PART LEAKAGE CURRENT . 45 Annex D (informative) PAT

41、IENT ENVIRONMENT 47 Annex E (normative) Allowable values for leakage currents from IEC 60601-1 . 48 Annex F (informative) Testing intervals 51 Annex G (informative) Example of test documentation . 52 Annex H (informative) Notes on testing ME SYSTEMS . 53 H.1 Overview 53 H.2 Guidelines for re-testing

42、 of an ME SYSTEM 53 H.3 Guidelines on ME SYSTEMS from the rationale annex of IEC 60601-1:2005 /AMD1:2012 54 H.4 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) 58 Bibliography 60 Index of defined terms 61 BS EN 62353:2014IEC 62353:2014 IEC 2014 3 Figure 1 Measuring circuit for the measureme

43、nt of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT that is disconnected from the SUPPLY MAINS 20 Figure 2 Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT or ME SYSTEMS, which for functional reasons cannot be disconnected from the SUPPLY MAINS, or in ME EQUIPMENT o

44、r ME SYSTEMS permanently connected to the SUPPLY MAINS 20 Figure 3 Measuring circuit for the measurement of the insulation resistance between MAINS PART and protective earth for CLASS I ME EQUIPMENT and between MAINS PART and (non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II ME EQUI

45、PMENT . 22 Figure 4 Measuring circuit for measurement of the insulation resistance between MAINS PART and APPLIED PARTS which make a patient connection for CLASS I or CLASS II ME EQUIPMENT . 23 Figure 5 Measuring circuit for measurement of the insulation resistance between F-TYPE APPLIED PARTS which

46、 make a patient connection and protective earth for CLASS I ME EQUIPMENT and between F-TYPE APPLIED PARTS which make a patient connection and (non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II ME EQUIPMENT 23 Figure 6 Measuring circuit for the measurement of ME EQUIPMENT leakage curr

47、ent alternative method 26 Figure 7 Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT direct method 27 Figure 8 Measuring circuit for the measurement EQUIPMENT LEAKAGE CURRENT differential method 28 Figure 9 Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT “F-TYP

48、E APPLIED PART” alternative method . 29 Figure 10 Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT MAINS VOLTAGE on F-TYPE APPLIED PART direct method 30 Figure 11 Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT for equipment with an INTERNAL ELECTRICAL POWE

49、R SOURCE direct method 30 Figure A.1 CLASS I ME EQUIPMENT with no earthed ACCESSIBLE CONDUCTIVE PARTS of the enclosure 37 Figure A.2 Plugged-in CLASS I ME EQUIPMENT 37 Figure A.3 Plugged-in CLASS II ME EQUIPMENT . 38 Figure A.4 Plugged-in CLASS I ME EQUIPMENT with mains on the APPLIED PART . 38 Figure A.5 Plugged-in CLASS II ME EQUIPMENT with mains on the APPLIED PART 39 Figure B.1 Sequence of testing 42 Figure B.2 Measurement of LEAKAGE CURRENTS (non-PERMANENTLY INSTALLED CLASS I M