1、BRITISH STANDARDBS EN 62353:2008Medical electrical equipment Recurrent test and test after repair of medical electrical equipmentICS 11.040.01g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g
2、60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN 62353:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 May 2008 BSI 2008ISBN 978 0 580 54254 1National forewordThis British Standard is the UK implementation of EN 62353:2008. It is identi
3、cal with IEC 62353:2007.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/1, Common aspects of electrical equipment used in medical practice. A list of organizations represented on CH/62/1 can be ob
4、tained on request to its secretary. BSI, as a member of CENELEC is obliged to publish EN 62353 as a British Standard. However, attention is drawn to the fact that during the development of this European Standard, the UK committee voted against its approval as a European Standard. The United Kingdom
5、objected to the publication of this standard for the following reasons: It is based on testing practice used in continental Europe. It contains test configurations which deviate from those in IEC 60601-1 (which is the standard that manufacturers use in their design processes) and would not be compar
6、able. There are aspects of the testing protocols and test limit values which UK experts do not agree with and therefore users are advised to treat results with caution. Well established methods of test and guideline documents from engineering institutions and the Medicines and Healthcare products Re
7、gulatory Agency (MHRA) exist for safety testing of medical electrical equipment. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligation
8、s.Amendments/corrigenda issued since publicationDate CommentsEUROPEAN STANDARD EN 62353 NORME EUROPENNE EUROPISCHE NORM January 2008 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Centra
9、l Secretariat: rue de Stassart 35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 62353:2008 E ICS 11.040 English version Medical electrical equipment - Recurrent test and test after repair of medical elect
10、rical equipment (IEC 62353:2007) Appareils lectromdicaux - Essai rcurrent et essai aprs rparation dun appareil lectromdical (CEI 62353:2007) Medizinische elektrische Gerte - Wiederholungsprfungen und Prfung nach Instandsetzung von medizinischen elektrischen Gerten (IEC 62353:2007) This European Stan
11、dard was approved by CENELEC on 2007-09-11. 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-to-date lists and bibliographical references concern
12、ing such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into it
13、s own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
14、Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Foreword The text of document 62A/564/FDIS, future edition 1 of IEC 62353, prepared by SC 62A, Common aspects of electrical equipmen
15、t used in medical practice, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 62353 on 2007-09-11. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication
16、 of an identical national standard or by endorsement (dop) 2008-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-10-01 In this standard, the following print types are used: requirements and definitions: roman type; informative material appeari
17、ng outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; TERMS USED THROUGHOUT THIS STANDARD THAT HAVE BEEN DEFINED IN CLAUSE 3: IN SMALL CAPITALS. The verbal forms used in this standard conform to usage described in Annex H o
18、f the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for comp
19、liance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.
20、Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 62353:2007 was approved by CENELEC as a European Standard without any modification. BS EN 62353:2008 2 CONTENTS 1 Scope.5 2 Normative references .6 3 Terms and definitions .6 4 Requirements .13 4.1 *
21、General requirements .13 4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR 14 4.3 * RECURRENT TEST .15 5 * Tests15 5.1 General .15 5.2 Visual INSPECTION 15 5.3 Measurements.16 5.4 Functional test.28 6 Results of test and evaluation.29 6.1 Reporting of results .29 6.2 Eva
22、luation .29 Annex A (informative) General guidance and rationale.30 Annex B (informative) Sequence of testing.37 Annex C (normative) Requirements for the measurement equipment and for measurement circuits for PROTECTIVE EARTH RESISTANCE and leakage currents 40 Annex D (informative) PATIENT ENVIRONME
23、NT42 Annex E (informative) Allowable values for leakage currents from IEC 60601-1 44 Annex F (informative) Testing intervals 47 Annex G (informative) Example of test documentation .48 Bibliography49 Index of defined terms 50 Figure 1 Measuring circuit for the measurement of PROTECTIVE EARTH RESISTAN
24、CE in ME EQUIPMENT that is disconnected from the SUPPLY MAINS 17 Figure 2 Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT or ME SYSTEM, which for functional reasons cannot be disconnected from SUPPLY MAINS, or in ME EQUIPMENT or ME SYSTEM permanently connected to
25、 mains 18 Figure 3 Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT alternative method 21 Figure 4 Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT direct method22 Figure 5 Measuring circuit for the measurement EQUIPMENT LEAKAGE CURRENT differential method 23 Anne
26、x ZA (normative) Normative references to international publications with theircorresponding European publications 52 BS EN 62353:2008 3 Figure 6 Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT “F-TYPE APPLIED PART” alternative method .24 Figure 7 Measuring circuit for the measu
27、rement of APPLIED PART LEAKAGE CURRENT MAINS VOLTAGE on F-TYPE APPLIED PART direct method.25 Figure 8 Measuring circuit for the measurement of APPLIED PART LEAKAGE CURRENT for equipment with an INTERNAL ELECTRICAL POWER SOURCE direct method .25 Figure 9 Measuring circuit for the measurement of the i
28、nsulation resistance between MAINS PART and protective earth for CLASS I equipment and between MAINS PART and (non-earthed) ACCESSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II equipment.27 Figure 10 Measuring circuit for measurement of the insulation resistance between MAINS PART and APPLIED PARTS
29、which make a patient connection .27 Figure 11 Measuring circuit for measurement of the insulation resistance between F-TYPE APPLIED PARTS which make a patient connection and protective earth for CLASS I equipment and between F-TYPE APPLIED PARTS which make a patient connection and (non-earthed) ACCE
30、SSIBLE CONDUCTIVE PARTS for CLASS I and CLASS II equipment28 Figure B.1 Sequence of testing 37 Figure B.2 Measurement of leakage currents (CLASS I ME EQUIPMENT) 38 Figure B.3 Measurement of leakage currents (CLASS II ME EQUIPMENT and ACCESSIBLE CONDUCTIVE PARTS of CLASS I ME EQUIPMENT, which are not
31、 connected to protective earth)39 Figure C.1 Example of a measuring device and its frequency characteristics .42 Figure D.1 Example of PATIENT ENVIRONMENT .43 Figure G.1 Example of test documentation.65H48 17HTable 1 Legends of symbols.66H19 18HTable 2 Allowable values for leakage currents67H26 19HT
32、able A.1 Addressees and their possible interest in this standard 68H30 20HTable A.2 Reasons for choosing different measuring methods .69H34 21HTable E.1 Allowable values for continuous leakage currents from IEC 60601-1:1988 .70H44 22HTable E.2 Allowable values for TOUCH CURRENTS, EARTH LEAKAGE CURRE
33、NTS, PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under NORMAL CONDITION and SINGLE FAULT CONDITION from IEC 60601-1:200571H45 23HTable E.3 Allowable values for PATIENT LEAKAGE CURRENTS under the special test conditions identified in 8.7.4.7 of IEC 60601-1:200572H46 BS EN 62353:2008 4 MED
34、ICAL ELECTRICAL EQUIPMENT RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT 1 Scope This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or sy
35、stems, which comply with IEC 60601-1, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment not built to IEC 60601-1 these requirements may be u
36、sed taking into account the safety standards for the design and information in the instructions for use of that equipment. This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is inde
37、pendent of the edition according to which the ME EQUIPMENT OR ME SYSTEM is designed. This standard contains: “general requirements“, which contain clauses of general concern, and “particular requirements“, further clauses handling special types of ME EQUIPMENT or ME SYSTEMS and applying in connectio
38、n with the “General requirements“. NOTE 1 At this stage, there are no particular requirements. This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMS or any other equipment comply with the relevant standards for their design. This standard does not define requirements for REPAIR,
39、 exchange of components and MODIFICATION of ME EQUIPMENT or ME SYSTEMS. NOTE 2 All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURERs instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requir
40、ements have to be assessed and verified. This standard is also applicable to tests after REPAIR. The testing shall be defined according to the extent of work performed and applicable guidance from the MANUFACTURER. This standard is not intended to define time intervals for RECURRENT TESTS. If such i
41、ntervals are not defined by the MANUFACTURER, Annex F may be used to help establish such intervals. BS EN 62353:2008 5 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated r
42、eferences, the latest edition of the referenced document (including any amendments) applies. IEC 60364-7-710, Electrical installations of buildings Part 7-710: Requirements for special installations or locations Medical locations IEC 60417, Graphical symbols for use on equipment IEC 61010-1, Safety
43、requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements IEC 61010-2-010, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-010: Particular requirements for laboratory equipment for the heating of mat
44、erials IEC 61010-031, 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 IEC 61140, Protection against electric shock Common aspects for installation and equipment I
45、EC 61557-1, Electrical safety in low voltage distribution systems up to 1000 V a.c. and 1500 V d.c. Equipment for testing, measuring or monitoring of protective measures Part 1: General requirements 3 Terms and definitions For the purposes of this document, the following terms and definitions apply.
46、 NOTE Some of the definitions have to be different than those in IEC 60601-1, as different measuring methods are used. 3.1 ACCESSIBLE CONDUCTIVE PART part of the ME EQUIPMENT other than an APPLIED PART, which is accessible to the patient, to the operator in contact with the patient or can come in co
47、ntact with the patient NOTE It is necessary that other accessible parts comply with their respective safety requirements. 3.2 ACCESSORY additional part for use with equipment in order to: achieve the intended use, adapt it to some special use, facilitate its use, enhance its performance, or enable i
48、ts functions to be integrated with those of other equipment IEC 60601-1:2005, definition 3.3 BS EN 62353:2008 6 3.3 ACCOMPANYING DOCUMENT document accompanying ME EQUIPMENT, an ME SYSTEM, equipment or an ACCESSORY and containing information for the RESPONSIBLE ORGANIZATION or operator, particularly
49、regarding basic safety and essential performance IEC 60601-1:2005, definition 3.4 3.4 APPLIED PART part of ME EQUIPMENT that in normal use necessarily comes into physical contact with the patient for ME EQUIPMENT or an ME SYSTEM to perform its function IEC 60601-1:2005, definition 3.8 3.5 APPLIED PART LEAKAGE CURRENT current flowing from MAINS PARTS and the ACCESSIBLE CONDUCTIVE PARTS of the enclosure to the APPLIED PARTS 3.6 CLASS I term
