1、BRITISH STANDARDBS EN 60601-1-3:2008Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008) ICS 11.040.50; 13.280g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g
2、56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58Incorporating+A11:2016corrigenda March 2010 and May 2014National forewordThis British Standard is the UK implementation of EN 60601-1-3:2008+A11:20
3、16, incorporating corrigenda March 2010 and May 2014. It is identical to IEC 60601-1-3:2008, incorporating amendment 1:2013. It supersedes BS EN 60601-1-3:2008+A1:2013, which will be withdrawnThe start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indic
4、ating 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, to Subcommittee CH/62/2, Diagnostic imaging e
5、quipment.A list of organizations represented on this 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.Compliance with a British Standard cannot confer im
6、munity from legal obligations.BS EN 60601-1-3:2008+A11:2016This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 30 September 2008Amendments/corrigenda issued since publicationDate Comments 31 July 2010 Implementation of CENELEC corrigendum March 2010.
7、Date of withdrawal added to Foreword31 July 2013 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2013. Annex ZA updated30 June 2014 Implementation of CENELEC corrigendum May 2014: Date of withdrawal updated in the Foreword and Foreword to amendment A1ISBN 978 0 580 96708 5 The Bri
8、tish StandardsInstitution 2016.Limited 2016Published by BSI Standards31 December 2016 Implementation of CENELEC amendment A11:2016:Annexes ZA and ZZ updatedon 1 November 2019.EUROPEAN STANDARD EN 60601-1-3 NORME EUROPENNE EUROPISCHE NORM CENELEC European Committee for Electrotechnical Standardizatio
9、n Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central 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 60601-1-3:2008 E IC
10、S 11.040.50; 13.280 English version Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008) Appareils lectromdicaux - Partie 1-3: Exigences gnrales pour la
11、scurit de base et les performances essentielles - Norme collatrale: Radioprotection dans les appareils rayonnement X de diagnostic (CEI 60601-1-3:2008) Medizinische elektrische Gerte - Teil 1-3: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnor
12、m: Strahlenschutz von diagnostischen Rntgengerten (IEC 60601-1-3:2008) This European Standard was approved by CENELEC on 2008-03-01. 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
13、 standard without 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 an
14、y other language 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, Cyprus, the Czech
15、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. :2008+A11Incorporating corrigenda March 201
16、0 and May 2014November 2016Foreword The text of document 62B/673/FDIS, future edition 2 of IEC 60601-1-3, 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 was approved by CENELEC as EN 60601-1
17、-3 on 2008-03-01. The following date was fixed: latest date by which the EN has to be implementedat national level by publication of an identicalnational standard or by endorsement(dop) 2008-12-01 This European Standard supersedes EN 60601-1-3:1994.This EN 60601-1-3 has been restructured and aligned
18、 to EN 60601-1:2006 and focussed on general requirements for RADIATION PROTECTION that apply to all diagnostic X-RAY EQUIPMENT. Requirements particular to specific equipment have been removed and will be covered in particular standards. For a description of the changes, see the mapping in Annex C. T
19、his European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafte
20、r referred to as the general standard. In the 60601 series of publications, collateral standards specify general requirements for safety applicable to: a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. RADIOLOGICAL equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not full
21、y addressed in the generalstandard (e.g. alarm systems).In this collateral standard, the following print types are used: requirements and definitions: in roman type; test specifications: in italic type; informative material appearing outside of tables, such as notes, examples and references: in smal
22、ler type. Normative text of tables is also in a smaller type; TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: IN SMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the thirteen numbered divisions within the table
23、 of contents, inclusive of allsubdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all subclauses ofClause 7).References to clauses within this standard are preceded by the term “Clause” followed by the cla
24、use number. References to subclauses within this standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. latest date by which the national standards conflictingwith the EN have to be withdra
25、wn (dow) 2018-12-31BS EN 60601-1-3:2008+A11:2016 EN 60601-1-3:2008+A11:2016 (E) 2 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 compliance with a requirement or
26、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 requirement or test. Clauses, subclauses
27、and definitions for which a rationale is provided in informative Annex A are marked with an asterisk (*). Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-1-3:2008 was approved by CENELEC as a European Standard without any modificati
28、on. _ The text of document 62B/895/CDV, future amendment 1 to edition 2 of IEC 60601-1-3, 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 60601-1-3:2008/A1:2013. The
29、 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) 2014-02-24 latest date by which the national standards conflicting with the document have to be withdrawn (dow) Attention is
30、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 CENELEC by the European Commission and the
31、 European Free Trade Association, and supports essential requirements of EU Directive(s). Endorsement notice The text of the International Standard IEC 60601-1-3:2008/A1:2013 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A12018-12-31BS EN 60601-1-3:20
32、08+A11:2016 EN 60601-1-3:2008+A11:2016 (E) 3 Foreword to amendment A11 This document (EN 60601-1-3:2008/A11:2016) has been prepared by CLC/TC 62 “Electrical equipment in medical practice“. The following dates are fixed: latest date by which the document has to be implemented at national level by pub
33、lication of an identical national standard or by endorsement (dop) 2017-11-01 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2019-11-01 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
34、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 Trade Association, and supports essential requirements of EU Directive(s). For the
35、 relationship with EU Directive(s) see informative Annex ZZ, which is an integral part of this document. BS EN 60601-1-3:2008+A11:2016 EN 60601-1-3:2008+A11:2016 (E) 4 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following
36、 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 amendments) applies. However, for any use
37、 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, th
38、is 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 referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. NOTE 2 When an i
39、nternational publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC 60336 Medical electrical equipment - X-ray tube assemblies for medical use - Characteristics of focal spots EN 60336 2005 IEC 60522 1999 Determina
40、tion of the permanent filtration of X-ray tube assemblies EN 60522 1999 IEC 60601-1 2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 A1 2012 EN 60601-1/A1 2013 EN 60601-1/A12 2014 IEC 60788 2004 Medical electrical equipment - G
41、lossary of defined terms ISO 497 Guide to the choice of series of preferred numbers and of series containing more rounded values of preferred numbers BS EN 60601-1-3:2008+A11:2016 EN 60601-1-3:2008+A11:2016 (E) 5 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This Europea
42、n Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements given in Annex I of EU Directive 93/42/EEC. General Guidance: Once this standard will be cited in the Offici
43、al Journal of the European Union under that Directive, compliance with the clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements (ERs) of that Directive and associated EFTA regu
44、lations. NOTE 1 The standards scope is limited to the specific uses, environments, contexts, objective situations specifically indicated. It cannot provide for presumption of conformity in other conditions. Some clauses or subclauses may be not applicable due to the specific type of equipment under
45、consideration. NOTE 2 Only prescriptions contained in the normative parts of the text are relevant to the presumption of conformity of this standard. Informative parts may, however, support users to interpret such prescriptions correctly. NOTE 3 Where a reference from a clause of this standard to th
46、e risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC. This means that risks have to be reduced “as far as possible“, “to a minimum“, “to the lowest possible level“, “minimized“ or “removed“, according to the wording of the corresponding es
47、sential requirement which must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety. NOTE 4 The manufacturers policy for det
48、ermining acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the directive. NOTE 5 For all parts of this standard that a) refer in their clauses to specific national legislation possibly exempting manufacturers from the thorough application of relevant
49、 provisions of this standard or b) link the completion of a relevant process/prescription to any discretional choice/power of manufacturers, the user of the standard should check that such clauses are in compliance with Directive 93/42/EEC. NOTE 6 This Annex ZZ is based on Normative References according to Annex ZA, replacing the references in the core text. WARNING: Other requirements and other EU Directives and Regulations may be applicable to the product(s) falling within the scope of this standar
