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1、BRITISH STANDARD BS EN 62353:2008 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment ICS 11.040.01 ? Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2
2、008 21:37:45 MDTNo reproduction or networking permitted without license from IHS -,-,- BS EN 62353:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 May 2008 BSI 2008 ISBN 978 0 580 54254 1 National foreword This British Standard is the
3、 UK implementation of EN 62353:2008. It is identical 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
4、 of organizations represented on CH/62/1 can be obtained 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 ap
5、proval as a European Standard. The United Kingdom 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
6、in their design processes) and would not be comparable. 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 institu
7、tions and the Medicines and Healthcare products Regulatory 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 Sta
8、ndard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publication DateComments Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:37:45 MDTNo reproduction or
9、networking permitted without license from IHS -,-,- EUROPEAN 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 Central Secreta
10、riat: 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 electrical equ
11、ipment (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 Standard was
12、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 concerning such
13、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 its own lan
14、guage 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, Italy, La
15、tvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resa
16、le, 08/14/2008 21:37:45 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword The text of document 62A/564/FDIS, future edition 1 of IEC 62353, prepared by SC 62A, Common aspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medi
17、cal 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 of an identical national standard or by endorsement (dop) 2008-08-01
18、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 appearing outside of tables, such as notes, examples and references: in small
19、er 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 of the ISO/IEC Directives, Part 2. For the purposes of this standard, t
20、he 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 compliance with this standard; “may” is used to describe a permissible way
21、 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. Annex ZA has been added by CENELEC. _ Endorsement notice The text of t
22、he International Standard IEC 62353:2007 was approved by CENELEC as a European Standard without any modification. BS EN 62353:2008 2 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:37:45 MD
23、TNo reproduction or networking permitted without license from IHS -,-,- CONTENTS 1 Scope.5 2 Normative references .6 3 Terms and definitions .6 4 Requirements .13 4.1 * General requirements .13 4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR14 4.3 * RECURRENT TEST.15 5
24、 * Tests15 5.1 General .15 5.2 Visual INSPECTION15 5.3 Measurements.16 5.4 Functional test.28 6 Results of test and evaluation.29 6.1 Reporting of results .29 6.2 Evaluation .29 Annex A (informative) General guidance and rationale.30 Annex B (informative) Sequence of testing.37 Annex C (normative) R
25、equirements for the measurement equipment and for measurement circuits for PROTECTIVE EARTH RESISTANCE and leakage currents 40 Annex D (informative) PATIENT ENVIRONMENT42 Annex E (informative) Allowable values for leakage currents from IEC 60601-1 44 Annex F (informative) Testing intervals 47 Annex
26、G (informative) Example of test documentation .48 Bibliography49 Index of defined terms 50 Figure 1 Measuring circuit for the measurement of PROTECTIVE EARTH RESISTANCE in ME EQUIPMENT that is disconnected from the SUPPLY MAINS17 Figure 2 Measuring circuit for the measurement of PROTECTIVE EARTH RES
27、ISTANCE 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 mains 18 Figure 3 Measuring circuit for the measurement of EQUIPMENT LEAKAGE CURRENT alternative method 21 Figure 4 Measuring circuit
28、for the measurement of EQUIPMENT LEAKAGE CURRENT direct method22 Figure 5 Measuring circuit for the measurement EQUIPMENT LEAKAGE CURRENT differential method 23 Annex ZA (normative) Normative references to international publications with their corresponding European publications 52 BS EN 62353:2008
29、3 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:37:45 MDTNo reproduction or networking permitted without license from IHS -,-,- Figure 6 Measuring circuit for the measurement of APPLIED P
30、ART LEAKAGE CURRENT “F-TYPE APPLIED PART” alternative method .24 Figure 7 Measuring circuit for the measurement 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 I
31、NTERNAL ELECTRICAL POWER SOURCE direct method .25 Figure 9 Measuring circuit for the measurement of the insulation 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 Figur
32、e 10 Measuring circuit for measurement of the insulation resistance between MAINS PART and APPLIED PARTS 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
33、CLASS I equipment and between F-TYPE APPLIED PARTS which make a patient connection and (non-earthed) ACCESSIBLE 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 leaka
34、ge currents (CLASS II ME EQUIPMENT and ACCESSIBLE CONDUCTIVE PARTS of CLASS I ME EQUIPMENT, which are not 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 documentat
35、ion. 65H 48 17H Table 1 Legends of symbols. 66H 19 18H Table 2 Allowable values for leakage currents 67H 26 19H Table A.1 Addressees and their possible interest in this standard 68H 30 20H Table A.2 Reasons for choosing different measuring methods . 69H 34 21H Table E.1 Allowable values for continuo
36、us leakage currents from IEC 60601-1:1988 . 70H 44 22H 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 71H 45 23H Table E.3 Allowable values for PATI
37、ENT LEAKAGE CURRENTS under the special test conditions identified in 8.7.4.7 of IEC 60601-1:2005 72H 46 BS EN 62353:2008 4 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 21:37:45 MDTNo reprod
38、uction or networking permitted without license from IHS -,-,- MEDICAL 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
39、 as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, 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. F
40、or equipment not built to IEC 60601-1 these requirements may be used 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 purpo
41、se of this standard, the application of measuring methods is independent 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 spec
42、ial types of ME EQUIPMENT or ME SYSTEMS and applying in connection 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 the
43、ir design. This standard does not define requirements for REPAIR, 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 d
44、esign of the equipment. Otherwise conformity to applicable requirements 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
45、 intended to define time intervals for RECURRENT TESTS. If such intervals are not defined by the MANUFACTURER, Annex F may be used to help establish such intervals. BS EN 62353:2008 5 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing C
46、o/5910770001 Not for Resale, 08/14/2008 21:37:45 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undat
47、ed references, 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, Saf
48、ety 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 materials IEC 61010-031, Safety requirements for electrica