EN 60601-2-33-2010 en Medical electrical equipment - Part 2-33 Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical di.pdf

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1、Medical electrical equipmentg51g68g85g87g3g21g16g22g22g29g3g51g68g85g87g76g70g88g79g68g85g3g85g72g84g88g76g85g72g80g72g81g87g86g3g73g82g85g3g87g75g72g3g69g68g86g76g70g86g68g73g72g87g92g3g68g81g71g3g72g86g86g72g81g87g76g68g79g3g83g72g85g73g82g85g80g68g81g70g72g3g82g73g3g80g68g74g81g72g87g76g70g85g72g

2、86g82g81g68g81g70g72g3g72g84g88g76g83g80g72g81g87g3g73g82g85g3g80g72g71g76g70g68g79g3g71g76g68g74g81g82g86g76g86BS EN 60601-2-33:2010+A12:2016Incorporating corrigenda October 2010, March 2012 and February 2016BSI Standards PublicationBS EN 60601-2-33:2010+A12:2016 BRITISH STANDARDNational forewordTh

3、is British Standard is the UK implementation of EN 60601-2-33:2010+A12:2016, incorporating corrigendum October 2010. It is identical to IEC 60601-2-33:2010, incorporating amendment 1:2013, amendment 2:2015, corrigendum March 2012 and corrigendum February 2016. It supersedes BS EN 60601-2-33:2010+A2:

4、2015, which will be withdrawn on 1 November 2019.The start and finish of text introduced or altered by corrigendum is indicated in the text by tags. For example, text altered by IEC corrigendum March 2012 is indicated in the text by g67g68.The start and finish of text introduced or altered by amendm

5、ent is indicated in the text by tags. Tags indicating changes to IEC text carry the number of the IEC amendment. For example, text altered by IEC amendment 1 is indicated by g1g2.BSI, as a member of CENELEC, is obliged to publish EN 60601-2-33 as a British Standard. However, attention is drawn to th

6、e fact that during the development of this European Standard, the UK committee voted against its approval as a European Standard.The UK Committee believes that the change in the instructions for use for scanning pregnant patients (in Subclause 201.7.9.2.101 u) should include the recommendation to li

7、mit rises in body temperature to less than 0,5C, as is recommended in Annex AA.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice, to Subcommittee CH/62/2, Diagnostic imaging equipment.A list of organizations represented on th

8、is subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 96709

9、2ICS 11.040.55Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2010.Amendments/corrigenda issued since publicationDate Text affected31 March 2011 Impl

10、ementation of CENELEC corrigendum October 2010; Annex ZZ revised30 April 2012 Implementation of CENELEC amendment A11:2011: Annex ZZ revised.31 July 2015 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2015. Annex ZA updated30 November 2015 Implementation of IEC amendment 2:2015 w

11、ith CENELEC endorsement A2:2015. Annex ZA updated31 May 2016 Implementation of IEC corrigenda March 2012 and February 201631 December 2016 Implementation of CENELEC amendment A12: Annex ZA and Annex ZZ updatedEUROPEAN STANDARD EN 60601-2-33NORME EUROPENNE EUROPISCHE NORM October 2011 CENELEC Europea

12、n Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Management Centre: Avenue Marnix 17, B - 1000 Brussels 2010 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENEL

13、EC members. Ref. No. EN 60601-2-33:2010 E ICS 11.040.55Supersedes EN 60601-2-33:2010English version Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010) Appareils l

14、ectromdicaux - Partie 2-33: Exigences particulires pour la scurit de base et les performances essentielles des appareils rsonance magntique utiliss pour le diagnostic mdical (CEI 60601-2-33:2010) Medizinische elektrische Gerte - Teil 2-33: Besondere Festlegungen fr die Sicherheit von Magnetresonanzg

15、erten fr die medizinische Diagnostik (IEC 60601-2-33:2010) This European Standard was approved by CENELEC on 2010-10-01. 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 wi

16、thout any alteration. Up-to-date lists and bibliographical references concerning 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 lang

17、uage made by translation under the responsibility of a CENELEC member into its 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, Croatia, Cyprus, the Czech Rep

18、ublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Incorporating corrigendum October 2010:2010+A1

19、1 EN 60601-2-33:2010+A1May 2015EN 60601-2-33:2010+A2September 2015EN 60601-2-33:2010+A12November 2016Foreword The text of document 62B/777/FDIS, future edition 3 of IEC 60601-2-33, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted

20、 to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-33 on 2010-10-01. This European Standard supersedes EN 60601-2-33:2002 + A1:2005 + A2:2008. This EN 60601-2-33:2010 is based on the second amendment to EN 60601-2-33:2002. It has also been adapted to EN 60601-1:2006, with te

21、chnical modifications being introduced where appropriate. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and CENELEC shall not be held responsible for identifying any or all such patent rights. The following dates were fixed:

22、 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2011-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2013-10-01 In this standard, the following print typ

23、es are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, I

24、N THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a

25、numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this particular standard are by number only. In this standard, the co

26、njunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. 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, the auxiliary verb: “shall” means that c

27、ompliance 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 to achieve compliance with a requireme

28、nt 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 AA. The contents of the corrigendum of October 2010 have been included in this copy.BS EN 60601-2-33:2010+A11:20

29、11 EN 60601-2-33:2010+A11:2011 (E) 2 2 BS EN 60601-2-33:2010+A1:2015EN 60601-2-33:2010+A1:2015 (E)BS EN 60601-2-33:2010+A2:2015EN 60601-2-33:2010+A2:2015 (E)BS EN 60601-2-33:2010+A12:2016EN 60601-2-33:2010+A12:2016 (E)This European Standard has been prepared under a mandate given to CENELEC by the E

30、uropean Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-33:2010 was approved by CENELEC as a European St

31、andard without any modification. _ Foreword This document (EN 60601-2-33:2010/A11:2011) has been prepared by CLC/TC 62 “Electrical equipment in medical practice”. The following dates are fixed: latest date by which this document has to be implemented at national level by publication of an identical

32、national standard or by endorsement (dop) 2012-10-01 latest date by which the national standards conflicting with this document have to be withdrawn (dow) 2014-10-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC and/or C

33、EN shall not be held responsible for identifying any or all such patent rights. to amendment A11BS EN 60601-2-33:2010+A11:2011 EN 60601-2-33:2010+A11:2011 (E) 3 3 BS EN 60601-2-33:2010+A1:2015EN 60601-2-33:2010+A1:2015 (E)BS EN 60601-2-33:2010+A2:2015EN 60601-2-33:2010+A2:2015 (E)BS EN 60601-2-33:20

34、10+A12:2016EN 60601-2-33:2010+A12:2016 (E)The text of document 62B/884/CDV, future IEC 60601-2-33:2010/A1, prepared by SC 62B “Diagnostic imaging equipment“ of IEC/TC 62 “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-33

35、:2010/A1:2015. The following dates are fixed: g120 latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2016-01-14 g120 latest date by which the national standards conflicting with the document have to be w

36、ithdrawn (dow) 2018-04-14 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 identifying any or all such patent rights. This document has been prepared under a mandate given to CEN

37、ELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in EN 60601-2-33:2010/A11:2011. Endorsement notice The text of the International Standard

38、 IEC 60601-2-33:2010/A1:2013 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-33:2010, the following note has to be added for the standard indicated: ISO 7010:2011 NOTE Harmonized as EN ISO 7010:2012 (not modified). Foreword to amendment A1 4

39、 BS EN 60601-2-33:2010+A2:2015EN 60601-2-33:2010+A2:2015 (E)BS EN 60601-2-33:2010+A12:2016EN 60601-2-33:2010+A12:2016 (E)Foreword to amendment A2The text of document 62B/977/FDIS, future IEC 60601-2-33:2010/A2 prepared by SC 62B “Diagnostic imaging equipment“ of IEC/TC 62 “Electrical equipment in me

40、dical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-33:2010/A2:2015. The following dates are fixed: g120 latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop)

41、 2016-04-23 g120 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-07-23 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

42、identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For the relationship with EU Directive 93/42/EEC, see informative Annex

43、 ZZ, included in EN 60601-2-33:2010/A11:2011. Endorsement notice The text of the International Standard IEC 60601-2-33:2010/A2:2015 was approved by CENELEC as a European Standard without any modification. In the Bibliography of EN 60601-2-33:2010, the following note has to be added for the standard

44、indicated: IEC 62570:2014 NOTE Harmonized as EN 62570:2015 (not modified). 5 BS EN 60601-2-33:2010+A12:2016EN 60601-2-33:2010+A12:2016 (E)This document (EN 60601-2-33:2010/A12:2016) has been prepared by CLC/TC 62 “Electrical equipment in medical practice“. The following dates are fixed: g120 latest

45、date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2017-11-01 g120 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2019-11-01 Attention is drawn to the possib

46、ility 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 identifying any or all such patent rights. This document has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trad

47、e Association, and supports essential requirements of EU Directive(s). For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. Foreword to amendment A12Annex ZA (normative) Normative references to international publications with their correspon

48、ding European publications The 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 a

49、mendments) applies. However, for any use of this standard “within the meaning of Annex ZZ“, the user must always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When the IEC or ISO standard is referred to in the IEC text standard, this must be understood as a normative reference to the parallel EN standard, as outlined below, including the foreword and the Annexes ZZ. NOTE 1 The way in which refer