BS EN 60601-1-12-2015 Medical electrical equipment General requirements for basic safety and essential performance Collateral Standard Requirements for medical electrical equipment.pdf

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1、BSI Standards PublicationMedical electrical equipmentPart 1-12: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environmentBS EN 60601-

2、1-12:2015National forewordThis British Standard is the UK implementation of EN 60601-1-12:2015. It isidentical to IEC 60601-1-12:2014.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in Medical Practice, toSubcommittee CH/62/1, Common aspects of

3、 Electrical Equipment used inMedical Practice.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standa

4、rds Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 75144 8ICS 11.040.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.Amendme

5、nts/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-1-12:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-1-12 May 2015 ICS 11.040 English Version Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance

6、- Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (IEC 60601-1-12:2014) Appareils lectromdicaux - Partie 1-12: Exigences gnrales pour la scurit de base et les performances essentielles -

7、Norme collatrale: Exigences pour les appareils lectromdicaux et les systmes lectromdicaux destins tre utiliss dans lenvironnement des services mdicaux durgence (IEC 60601-1-12:2014) Medizinische elektrische Gerte - Teil 1-12: Allgemeine Festlegungen fr die Sicherheit einschlielich der wesentlichen L

8、eistungsmerkmale - Ergnzungsnorm: Anforderungen an medizinische elektrische Gerte und medizinische elektrische Systeme in der Umgebung fr den Notfalleinsatz (IEC 60601-1-12:2014) This European Standard was approved by CENELEC on 2014-07-24. CENELEC members are bound to comply with the CEN/CENELEC In

9、ternal 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 national standards may be obtained on application to the CEN-CENELEC Management Centre or to a

10、ny 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 language and notified to the CEN-CENELEC Management Centre has the same status as the o

11、fficial versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembour

12、g, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung CEN-CE

13、NELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members. Ref. No. EN 60601-1-12:2015 E BS EN 60601-1-12:2015EN 60601-1-12:2015 2 Foreword The text of document 62A/932/FDIS, future edition 1

14、 of IEC 60601-1-12, 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 parallel vote and approved by CENELEC as EN 60601-1-12:2015. The following dates are fixed: latest date

15、by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2015-11-22 latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2018-12-31 Attention is drawn to the possibility that

16、 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 Trade Associat

17、ion, and supports essential requirements of EU Directive(s). For the relationship with EU Directives 93/42/EEC and 90/385/EEC, see informative Annexes ZZA and ZZB, which are integral parts of this document. Endorsement notice The text of the International Standard IEC 60601-1-12:2014 was approved by

18、 CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC 60038:2009 NOTE Harmonized as EN 60038:2011 (modified). IEC 60065 NOTE Harmonized as EN 60065. IEC 60335-1:2010 NOTE Harmonized a

19、s EN 60335-1:2012 (modified). IEC 60364 NOTE Harmonized in HD 384 / HD 60364 series (partly modified). IEC 60721-3-7:1995 + A1:1996 NOTE Harmonized as EN 60721-3-7:1995 (not modified) + A1:1997 (not modified). IEC 60950-1:2005 NOTE Harmonized as EN 60950-1:2006 (modified). IEC 61032:1997 NOTE Harmon

20、ized as EN 61032:1998 (not modified). ISO 10651-2:2004 NOTE Harmonized as EN ISO 10651-2:2009 (not modified). BS EN 60601-1-12:2015EN 60601-1-12:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in w

21、hole 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. NOTE 1 When an International Publica

22、tion has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu. Publication Year Title EN/HD Year IEC 60068-2-27 2008 Environmental t

23、esting - Part 2-27: Tests - Test Ea and guidance: Shock EN 60068-2-27 2009 IEC 60068-2-31 2008 Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens EN 60068-2-31 2008 IEC 60068-2-64 2008 Environmental testing - Part 2-64: Tests - Test Fh:

24、Vibration, broadband random and guidance EN 60068-2-64 2008 IEC 60529 - + A1 1989 - 1999 Degrees of protection provided by enclosures (IP Code) EN 60529 + corrigendum May + A1 1991 1993 2000 IEC 60601-1 - + A1 - 2005 - 2012 - Medical electrical equipment - Part 1: General requirements for basic safe

25、ty and essential performance EN 60601-1 + corrigendum Mar. + A1 + A1/AC 2006 2010 2013 2014 IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests EN 6060

26、1-1-2 2014 IEC 60601-1-6 + A1 2010 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6 + A1 2010 2015 IEC 60601-1-8 - + A1 - 2006 - 2012 - Medical electrical equipment - Part 1-8: General requirem

27、ents for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 + corrigendum Mar. + A1 + A1/AC 2007 2010 2013 2014 BS EN 60601-1-12:2015EN 60601-1-12:2015 4

28、Publication Year Title EN/HD Year IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

29、EN 60601-1-11 2015 CISPR 11 (mod) 2009 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement EN 55011 2009 ISO 7000 2014 Graphical symbols for use on equipment - Registered symbols - - ISO 7010 + A1 + A2 + A3 + A4 + A5 2011 201

30、2 2012 2012 2013 2014 Graphical symbols - Safety colours and safety signs - Registered safety signs EN ISO 7010 + A1 + A2 + A3 + A4 + A5 2012 2014 2014 2014 2014 2015 ISO 15223-1 2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1:

31、General requirements EN ISO 15223-1 2012 BS EN 60601-1-12:2015EN 60601-1-12:2015 5 Annex ZZA (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association,

32、 and within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned. WA

33、RNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-1-12:2015EN 60601-1-12:2015 6 Annex ZZB (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mandate g

34、iven to CENELEC by the European Commission and the European Free Trade Association, and within its scope the Standard covers all relevant essential requirements given in Annex 1 of EU Directive 90/385/EEC of 20 June 1990 relating to active implantable medical devices. Compliance with this standard p

35、rovides one means of conformity with the specified essential requirements of the Directive concerned. WARNING: Other requirements and other EU Directives can be applied to the products falling within the scope of this standard. BS EN 60601-1-12:2015 2 IEC 60601-1-12:2014 IEC 2014 CONTENTS FOREWORD .

36、 4 INTRODUCTION . 7 1 Scope, object and related standards 8 1.1 * Scope . 8 1.2 * Object 8 1.3 Related standards . 9 1.3.1 IEC 60601-1 9 1.3.2 Particular standards . 9 2 Normative references 9 3 Terms and definitions 10 4 General requirements 11 4.1 * Additional requirements for SUPPLY MAINS for ME

37、EQUIPMENT and ME SYSTEMS 11 4.2 * Environmental conditions for ME EQUIPMENT 11 4.2.1 * Environmental conditions of transport and storage between uses 12 4.2.2 * Environmental operating conditions . 13 5 * Classification of ME EQUIPMENT and ME SYSTEMS 15 6 ME EQUIPMENT identification, marking and doc

38、uments 16 6.1 * Additional requirements for legibility of markings 16 6.2 * Additional requirements for marking of IP classification 16 6.3 * Instructions for use . 16 6.3.1 Additional general requirements 16 6.3.2 * Additional requirements for an electrical power source 17 6.3.3 Additional requirem

39、ents for ME EQUIPMENT start-up PROCEDURE 17 6.3.4 * Additional requirements for operating instructions . 18 6.3.5 Additional requirements for ME EQUIPMENT messages . 18 6.4 Technical description FIXED or PERMANENTLY INSTALLED CLASS I ME EQUIPMENT . 18 7 * Protection against electrical HAZARDS from M

40、E EQUIPMENT 18 8 Protection against excessive temperatures and other HAZARDS 19 8.1 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS . 19 8.1.1 * Ingress of water or particulate matter into ME EQUIPMENT . 19 8.1.2 * Ingress of water or particulate m

41、atter into ME SYSTEMS 19 8.2 Additional requirements for interruption of the power supply to ME EQUIPMENT and ME SYSTEM 19 8.3 * Additional requirements for INTERNAL ELECTRICAL POWER SOURCE for ME EQUIPMENT . 20 9 * Accuracy of controls and instruments and protection against hazardous outputs . 21 1

42、0 Construction of ME EQUIPMENT 21 10.1 * Additional requirements for mechanical strength of ME EQUIPMENT intended for the EMS ENVIRONMENT . 21 10.1.1 General requirements for mechanical strength . 21 10.1.2 * Requirements for mechanical strength for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT intend

43、ed for use in a road ambulance 22 10.1.3 * Requirements for mechanical strength for TRANSPORTABLE ME EQUIPMENT 23 BS EN 60601-1-12:2015IEC 60601-1-12:2014 IEC 2014 3 10.1.4 * Requirements for mechanical strength for ME EQUIPMENT intended for airborne use 24 10.2 Requirements for mounting of ME EQUIP

44、MENT . 25 11 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 25 Annex A (informative) General guidance and rationale . 26 A.1 General guidance 26 A.2 Rationale for particular clauses and subclauses 28 Annex B (informative) Guide to marking and labelling req

45、uirements for ME EQUIPMENT and ME SYSTEMS 42 B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts 42 B.2 ACCOMPANYING DOCUMENTS, instructions for use 42 B.3 ACCOMPANYING DOCUMENTS, technical description 43 Annex C (informative) Symbols on marking 44 Bibliography 46 Index of defined

46、terms used in this collateral standard 48 Figure A.1 Saturation water vapour pressure as function of temperature 31 Table 1 Mechanical strength test applicability 22 Table A.1 Saturation water vapour pressure as function of temperature . 32 Table B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEM

47、S or their parts . 42 Table B.2 ACCOMPANYING DOCUMENTS, instructions for use . 42 Table B.3 ACCOMPANYING DOCUMENTS, technical description . 43 Table C.1 General symbols 44 BS EN 60601-1-12:2015 4 IEC 60601-1-12:2014 IEC 2014 INTERNATIONAL ELECTROTECHNICAL COMMISSION _ MEDICAL ELECTRICAL EQUIPMENT Pa

48、rt 1-12: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment FOREWORD 1) The International Electrotechnical Commission (IEC) is

49、 a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication