1、 IEC 62353 Edition 2.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Recurrent test and test after repair of medical electrical equipment Appareils lectromdicaux Essai rcurrent et essai aprs rparation dun appareil lectromdical IEC 62353:2014-09(en-fr) colour inside
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19、Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 62353 Edition 2.0 2014-09 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Recurrent test and test after repair of medical electrical equipment Appar
20、eils lectromdicaux Essai rcurrent et essai aprs rparation dun appareil lectromdical INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE XB ICS 11.040 PRICE CODE CODE PRIX ISBN 978-2-8322-1847-1 Registered trademark of the International Electrotechnical Commission Mar
21、que dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. colour inside 2 IEC 62353:2014 IEC 2014 CONTENTS FOREWORD
22、. 5 1 Scope 7 2 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 1
23、9 5.3.1 General . 19 5.3.2 Measuring of PROTECTIVE EARTH RESISTANCE 19 * Measurement of insulation resistance (not mandatory) 21 5.3.3Leakage currents . 24 5.3.4 5.4 Functional test 31 6 Results of test and evaluation 31 6.1 Reporting of results. 31 6.2 Evaluation . 32 Annex A (informative) General
24、guidance and rationale . 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 le
25、akage currents . 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 .
26、45 Annex D (informative) 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
27、.2 Guidelines for 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 IEC 62353:2014 IEC 2014 3 Figure 1 Measuring circuit for
28、the measurement 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 M
29、E EQUIPMENT or 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 CLA
30、SS II ME EQUIPMENT . 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 APPLI
31、ED PARTS which 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 EQUIPMEN
32、T leakage current 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
33、CURRENT “F- TYPE 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
34、ELECTRICAL POWER 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
35、 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 ME EQUIPMENT) 43 Figure C.1 Example of a measuring device and its frequency characteristics . 46 Fi
36、gure D.1 Example of PATIENT ENVIRONMENT . 47 Figure G.1 Example of test documentation . 52 Figure H.1 Example of the construction of a MULTIPLE SOCKET-OUTLET (MSO) (accessible only with the use of a tool) 58 Figure H 2 Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) 59 Table 1 Legends of sy
37、mbols 21 Table 2 Insulation resistance values 24 Table 3 Allowable values for leakage currents . 31 Table A.1 Addressees and their possible interest in this standard 33 Table A.2 Reasons for choosing different measuring methods . 40 4 IEC 62353:2014 IEC 2014 Table E.1 Allowable values for continuous
38、 leakage currents from IEC 60601-1:1988 . 48 Table E.2 Allowable values for TOUCH CURRENTS, EARTH LEAKAGE CURRENTS, PATIENT LEAKAGE CURRENTS and patient auxiliary currents under NORMAL CONDITION and SINGLE FAULT CONDITION from IEC 60601-1:2005 . 49 Table E.3 Allowable values for PATIENT LEAKAGE CURR
39、ENTS under the special test conditions identified in 8.7.4.7 of IEC 60601-1:2005 . 50 Table H.1 Some examples of ME SYSTEMS for illustration. 56 IEC 62353:2014 IEC 2014 5 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRIC
40、AL EQUIPMENT FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardi
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