1、BRITISH STANDARDBS EN 60601-1:2006Medical electrical equipment Part 1: General requirements for basic safety and essential performanceICS 11.040.01 BS EN +A12:2014Incorporating corrigendaDecember 2006, December 2007, March 2010 and July 2014National forewordThis British Standard is the UK implementa
2、tion of EN 60601-1:2006+A12:2014. It is identical to IEC 60601-1:2005, incorporating amendment A1:2013 and corrigendum July 2014. It supersedes BS EN 60601-1:2006 +A1:2013, which will be withdrawn on 26 March 2015.The start and finish of text introduced or altered by corrigendum is indicated in the
3、text by tags. Text altered by IEC corrigendum December 2006 is indicated in the text by . Text altered by IEC corrigendum December 2007 is indicated in the text by . Text altered by IEC corrigendum July 2014 is indicated in the text by .The start and finish of text introduced or altered by amendment
4、 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 !“.The UK participation in its preparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice,
5、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.The publication does not purport to include all the necessary provisions of a contract. Users are responsible
6、for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN 60601-1:2006+A12:2014This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 30 November 2006Amendments/corrigenda issued since publication
7、Date Comments 31 May 2011 Implementation of IEC corrigenda December 2006and December 2007 (tagged) and implementation ofCENELEC corrigendum March 2010: modification ofCENELEC Foreword and Annexes ZA and ZZ29 February 2012 Implementation of CENELEC amendment A11:2011:Annex ZZ replaced by Annexes ZZA
8、and ZZB31 December 2012 Implementation of IEC amendment 1:2013 withCENELEC endorsement A1:2013. Annex ZA replacedand Annex ZZ added30 November 2014 Implementation of IEC corrigendum July 2014: Figure 12 updated30 November 2014 Implementation of CENELEC amendment A12:2014: Annex ZZ updated to Annex Z
9、ZA, previous Annex ZZA deleted. Annez ZZB insertedISBN 978 0 580 88318 7 The British Standards Institution 2014. Published by BSI Standards Limited 2014EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM CENELEC European Committee for Electrotechnical StandardizationComit Europen de Normalisation Elec
10、trotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2011 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.Ref. No. EN 60601-1:2006 EICS 11.040 Supersedes EN 60601-1:2006English
11、version Medical electrical equipment Part 1: General requirements for basic safetyand essential performance (IEC 60601-1:2005)Appareils lectromdicauxPartie 1: Exigences gnrales pour la scurit de base et les performances essentielles (CEI 60601-1:2005)Medizinische elektrische Gerte Teil 1: Allgemeine
12、 Festlegungenfr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale (IEC 60601-1:2005)This European Standard was approved by CENELEC on 2006-09-12. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standar
13、d the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained onapplication to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French,
14、 German). A version in any otherlanguage made by translation under the responsibility of a CENELEC member into its own language and notifiedto the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Cypru
15、s, the Czech Republic, 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. EN 60601-1:2006+AOctober 201421
16、Foreword The text of document 62A/505A/FDIS, future edition 3 of IEC 60601-1, prepared bySC 62A, Commonaspects of electrical equipment 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 CENELECas EN 606
17、01-1 on 2006-09-12. The following date was 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) 2007-07-01 This European Standard supersedes EN 60601-1:1990 and its amendments. This EN 60601-1:2006 has bee
18、n significantly restructured compared to EN 60601-1:1990.Requirements in the electrical section have been further aligned with those for information technologyequipment covered by EN 60950-1 and a requirement for including a RISK MANAGEMENTPROCESS has been added. For an expanded description of this
19、revision, see Clause A.3. This European Standard has been prepared under a mandate given to CENELEC by the EuropeanCommission and the European Free Trade Association and covers essential requirements of EC Directives 90/385/EEC and 93/42/EEC. See Annex ZZ.In this standard the following print types a
20、re used: requirements and definitions: in roman type; testspecifications: in italic type; informative material appearing outside of tables,such as notes, examples and references: in smaller type. Normative textof tables is also in a smaller type; TERMS USED THROUGHOUT THISSTANDARD THAT HAVEBEEN DEFI
21、NED IN CLAUSE 3 AND ALSO GIVEN INTHE INDEX: IN 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 ofall subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.); subclause means
22、a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclausesof Clause 7). References to clauses within this standard are preceded by the term Clause followed by the clause number. References to subclauses within this standard are by number only. In this standard, theconjunctive or
23、is used as an inclusive or so a statement is true if any combination of the conditionsis true. The verbal forms used in this standard conform to usage described in Annex G of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb: shall means that compliance with a req
24、uirement 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; mayis used to describe a permissible way to achieve compliance with a requirement or test. latest date b
25、y which the national standards conflictingwith the EN have to be withdrawn. (dow) 2012-06-01 EN 60601-1:2006/A1:2013 - 2 -ForewordThe text of document 62A/805/FDIS, future IEC 60601-1:2005/A1, prepared by SC 62A, “Common aspects of electrical equipment used in medical practice“, of IEC TC 62, “Elect
26、rical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1:2006/A1:2013.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 endor
27、sement(dop) 2014-06-24 latest date by which the national standards conflicting with the document have to be withdrawn(dow) 2018-12-24In the foreword of EN 60601-1:2006, replace the first sentence of the third paragraph by: This European Standard supersedes EN 60601-1:1990 and its amendments, EN 6060
28、1-1-1:2001 and EN 60601-1-4:1996 + A1:1999.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 mand
29、ate given to CENELEC by the European Commission and the European Free Trade 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.Endorsement noticeThe text of the Internation
30、al Standard IEC 60601-1:2005/A1:2012 was approved by CENELEC as a European Standard without any modification.Replace the Bibliography of EN 60601-1:2006 by:IEC 60073 NOTE Harmonized as EN 60073.IEC 60086-1 NOTE Harmonized as EN 60086-1.IEC 60127-6 NOTE Harmonized as EN 60127-6.IEC 60309-1 NOTE Harmo
31、nized as EN 60309-1.IEC 60332-1-2 NOTE Harmonized as EN 60332-1-2.IEC 60332-2-2 NOTE Harmonized as EN 60332-2-2.IEC 60317-43 NOTE Harmonized as EN 60317-43.IEC 60601-1-1:2000 NOTE Harmonized as EN 60601-1-1:2001 (not modified).IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996 + A1:1999 (not mo
32、dified).IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.IEC 60601-2-22 NOTE Harmonized as EN 60601-2-22.IEC 60601-2-49:2001 NOTE Harmonized as EN 60601-2-49:2001 (not modified).- 2 -BS EN 60601-1:2006+A12:2014 EN 60601-1:2006+A12:2014 (E)An asterisk(* ) as the first character of a title or at the be
33、ginning of a paragraph or table title indicatesthat there is guidance or rationale related to that item in Annex A. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement noticeThe text of the International Standard IEC 60601-1:2005 was approved by CENELEC as a EuropeanStandard without any modi
34、fication. _ The contents of the corrigendum of March 2010 have been included in this copy.Foreword to amendment A11 This document (EN 60601-1:2006/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 ha
35、s to be implemented at national level by publication of an identical 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 o
36、f 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. EN 60601-1:2006/A1:2013 - 2 -ForewordThe text of document 62A/805/FDIS, future IEC 60601-1:2005/A1, prepared by SC 62A, “Common aspects of electrical e
37、quipment used in medical practice“, of IEC TC 62, “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1:2006/A1:2013.The following dates are fixed: latest date by which the document has to be implemented at national level by p
38、ublication of an identical national standard or by endorsement(dop) 2014-06-24 latest date by which the national standards conflicting with the document have to be withdrawn(dow) 2018-12-24In the foreword of EN 60601-1:2006, replace the first sentence of the third paragraph by: This European Standar
39、d supersedes EN 60601-1:1990 and its amendments, EN 60601-1-1:2001 and EN 60601-1-4:1996 + A1:1999.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 pa
40、tent 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(s).For the relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of thi
41、s document.Endorsement noticeThe text of the International Standard IEC 60601-1:2005/A1:2012 was approved by CENELEC as a European Standard without any modification.Replace the Bibliography of EN 60601-1:2006 by:IEC 60073 NOTE Harmonized as EN 60073.IEC 60086-1 NOTE Harmonized as EN 60086-1.IEC 6012
42、7-6 NOTE Harmonized as EN 60127-6.IEC 60309-1 NOTE Harmonized as EN 60309-1.IEC 60332-1-2 NOTE Harmonized as EN 60332-1-2.IEC 60332-2-2 NOTE Harmonized as EN 60332-2-2.IEC 60317-43 NOTE Harmonized as EN 60317-43.IEC 60601-1-1:2000 NOTE Harmonized as EN 60601-1-1:2001 (not modified).IEC 60601-1-4:199
43、6 NOTE Harmonized as EN 60601-1-4:1996 + A1:1999 (not modified).IEC 60601-1-11 NOTE Harmonized as EN 60601-1-11.IEC 60601-2-22 NOTE Harmonized as EN 60601-2-22.IEC 60601-2-49:2001 NOTE Harmonized as EN 60601-2-49:2001 (not modified).Foreword to amendment A1- 3 -BS EN 60601-1:2006+A12:2014 EN 60601-1
44、:2006+A12:2014 (E)EN 60601-1:2006/A1:2013 - 2 -ForewordThe text of document 62A/805/FDIS, future IEC 60601-1:2005/A1, prepared by SC 62A, “Common aspects of electrical equipment used in medical practice“, of IEC TC 62, “Electrical equipment in medical practice“ was submitted to the IEC-CENELEC paral
45、lel vote and approved by CENELEC as EN 60601-1:2006/A1:2013.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) 2014-06-24 latest date by which the national (dow) 2018-12-24Th
46、is European Standard supersedes EN 60601-1:1990 and its amendments, EN 60601-1-1:2001 and EN 60601-1-4:1996 + A1:1999.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
47、 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(s).For the relationship with EU Directive(s) see informative Annex ZZ, which is an i
48、ntegral part of this document.Endorsement noticeThe text of the International Standard IEC 60601-1:2005/A1:2012 was approved by CENELEC as a European Standard without any modification.Replace the Bibliography of EN 60601-1:2006 by:IEC 60073 NOTE Harmonized as EN 60073.IEC 60086-1 NOTE Harmonized as
49、EN 60086-1.IEC 60127-6 NOTE Harmonized as EN 60127-6.IEC 60309-1 NOTE Harmonized as EN 60309-1.IEC 60332-1-2 NOTE Harmonized as EN 60332-1-2.IEC 60332-2-2 NOTE Harmonized as EN 60332-2-2.IEC 60317-43 NOTE Harmonized as EN 60317-43.IEC 60601-1-1:2000 NOTE Harmonized as EN 60601-1-1:2001 (not modified).IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996 + A1:19
