BS EN 60601-1-11-2015 Medical electrical equipment General requirements for basic safety and essential performance Collateral Standard Requirements for medical electrical equipment.pdf

1、BSI Standards PublicationMedical electrical equipmentPart 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 environmentBS EN 60601-1-11:2015National forew

2、ordThis British Standard is the UK implementation of EN 60601-1-11:2015. It isidentical to IEC 60601-1-11:2015. It supersedes BS EN 60601-1-11:2010,which will be withdrawn on 31 December 2018.The UK participation in its preparation was entrusted by TechnicalCommittee CH/62, Electrical Equipment in M

3、edical Practice, toSubcommittee CH/62/1, Common aspects of 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 r

4、esponsible for its correct application. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 85662 4ICS 11.040.01Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStand

5、ards Policy and Strategy Committee on 30 June 2015.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN 60601-1-11:2015EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-1-11 May 2015 ICS 11.040 Supersedes EN 60601-1-11:2010 English Version Medical electrical

6、 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 (IEC 60601-1-11:2015) Appareils lectromdicaux - Partie 1-11: Exigences g

7、nrales pour la scurit de base et les performances essentielles - Norme Collatrale: Exigences pour les appareils lectromdicaux et les systmes lectromdicaux utiliss dans lenvironnement des soins domicile (IEC 60601-1-11:2015) Medizinische elektrische Gerte - Teil 1-11: Besondere Festlegungen fr die Si

8、cherheit einschlielich der wesentlichen Leistungsmerkmale - Ergnzungsnorm: Anforderungen an medizinische elektrische Gerte und medizinische elektrische Systeme fr die medizinische Versorgung in huslicher Umgebung (IEC 60601-1-11:2015) This European Standard was approved by CENELEC on 2015-04-14. CEN

9、ELEC 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 national standards may be obtained on

10、application to the CEN-CENELEC Management Centre 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 language and notified to the CE

11、N-CENELEC Management Centre has the same status as the official 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, Hungar

12、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, 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

13、 Europisches Komitee fr Elektrotechnische Normung CEN-CENELEC 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 60601-1-11:2015 E BS EN 60601-1-11:2015EN 60601-1-11:2015 2 Fore

14、word The text of document 62A/959/FDIS, future edition 2 of IEC 60601-1-11, 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

15、-1-11:2015. 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) 2016-01-14 latest date by which the national standards conflicting with the document have to be withdrawn (dow

16、) 2018-12-31 This document supersedes EN 60601-1-11:2010. 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 prepa

17、red 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 93/42/EEC, see informative Annex ZZ, which is an integral part of this document. Endorsement notice

18、The text of the International Standard IEC 60601-1-11:2015 was approved by 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).

19、 IEC 60065:2014 NOTE Harmonized as EN 60065:2014 (modified). IEC 60335-1:2010 NOTE Harmonized as EN 60335-1:2012 (modified). IEC 60364 NOTE Harmonized in HD 384 / HD 60364 series (partly modified). IEC 60601-1-9 NOTE Harmonized as EN 60601-1-9. IEC 60721-3-7:1995 NOTE Harmonized as EN 60721-3-7:1995

20、 (not modified). BS EN 60601-1-11:2015EN 60601-1-11:2015 3 IEC 60950-1:2005 + A1:2009 + A2:2013 NOTE Harmonized as EN 60950-1:2006 (modified) + A1:2010 (modified) + A2:2013 (modified). IEC 61032:1997 NOTE Harmonized as EN 61032:1998 (not modified). ISO 10651-2:2004 NOTE Harmonized as EN ISO 10651-2:

21、2009 (not modified). BS EN 60601-1-11:2015EN 60601-1-11:2015 4 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for it

22、s 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 Publication has been modified by common modifications, indicated by (mod), the relevant EN/HD ap

23、plies. 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 testing - Part 2-27: Tests - Test Ea and guidance: Shock EN 60068-2-27 2009 IEC 60068-2-31

24、 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: Vibration, broadband random and guidance EN 60068-2-64 2008 IEC 60529 1989 Degrees of pro

25、tection provided by enclosures (IP Code) EN 60529 1991 - - + corrigendum May 1993 + A1 1999 + A1 2000 + A2 2013 + A2 2013 IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 2006 - - + corrigendum Mar. 2010 + A1 2012 + A1

26、 2013 - - + A1/AC 2014 - - + A12 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 60601-1-2 2014 IEC 60601-1-6 2010 Medical electrical equip

27、ment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability EN 60601-1-6 2010 + A1 2013 + A1 2015 BS EN 60601-1-11:2015EN 60601-1-11:2015 5 Publication Year Title EN/HD Year IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requ

28、irements 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 2007 - - + corrigendum Mar. 2010 + A1 2012 + A1 2013 - - + A1/AC 2014 IEC 60601-1-12 2014

29、Medical electrical equipment - Part 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 EN 60601-1-12 2015 IEC 62366 20

30、07 Medical devices - Application of usability engineering to medical devices EN 62366 2008 + A1 2014 + A1 2015 CISPR 11 (mod) 2009 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement EN 55011 2009 ISO 7000 - Graphical symbols

31、 for use on equipment - Registered symbols - - ISO 7010 2011 Graphical symbols - Safety colours and safety signs - Registered safety signs EN ISO 7010 2012 + A1 2012 + A1 2014 + A2 2012 + A2 2014 + A3 2012 + A3 2014 + A4 2013 + A4 2014 + A5 2014 + A5 2015 ISO 15223-1 2012 Medical devices - Symbols t

32、o be used with medical device labels, labelling and information to be supplied - Part 1: General requirements EN ISO 15223-1 2012 BS EN 60601-1-11:2015EN 60601-1-11:2015 6 Annex ZZ (informative) Coverage of Essential Requirements of EU Directives This European Standard has been prepared under a mand

33、ate given 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 I of EU Directive 93/42/EEC of 14 June 1993 concerning medical devices. Compliance with this standard provides one mean

34、s 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 60601-1-11:2015 2 IEC 60601-1-11:2015 IEC 2015 CONTENTS FOREWORD . 5 INTRODUCTION

35、. 8 1 Scope, object and related standards 9 1.1 * Scope . 9 1.2 Object . 9 1.3 Related standards . 9 IEC 60601-1 9 1.3.1Particular standards . 10 1.3.22 Normative references 10 3 Terms and definitions 11 4 General requirements 12 4.1 * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME

36、 SYSTEMS . 12 4.2 * Environmental conditions for ME EQUIPMENT 12 General . 12 4.2.1* Environmental conditions of transport and storage between uses 13 4.2.2* Environmental operating conditions . 14 4.2.35 * General requirements for testing ME EQUIPMENT . 16 6 * Classification of ME EQUIPMENT and ME

37、SYSTEMS 17 7 ME EQUIPMENT identification, marking and documents 17 7.1 * USABILITY of the ACCOMPANYING DOCUMENTS 17 7.2 * Additional requirements for marking of IP classification 18 7.3 ACCOMPANYING DOCUMENTS . 18 Contact information . 18 7.3.1LAY OPERATOR briefing information . 18 7.3.27.4 Instruct

38、ions for use . 19 Additional requirements for warning and safety notices 19 7.4.1* Additional requirements for an electrical power source 19 7.4.2Additional requirements for ME EQUIPMENT description 20 7.4.3Additional requirements for ME EQUIPMENT start-up PROCEDURE 20 7.4.4Additional requirements f

39、or operating instructions 20 7.4.5Additional requirements for ME EQUIPMENT messages . 21 7.4.6* Additional requirements for cleaning, disinfection and sterilization . 21 7.4.7Additional requirements for maintenance . 21 7.4.8Additional requirements for environmental protection . 21 7.4.9Additional r

40、equirements for ME EQUIPMENT and ME SYSTEMS 22 7.4.107.5 Technical description 22 PERMANENTLY INSTALLED CLASS I ME EQUIPMENT 22 7.5.1Additional requirements for professional hygienic maintenance . 22 7.5.28 Protection against excessive temperatures and other HAZARDS 22 8.1 * Additional requirements

41、for cleaning, disinfection of ME EQUIPMENT and ME SYSTEMS . 22 8.2 * Additional requirements for sterilization of ME EQUIPMENT and ME SYSTEMS 23 8.3 Additional requirements for ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS 23 * Ingress of water or particulate matter into ME

42、 EQUIPMENT . 23 8.3.1BS EN 60601-1-11:2015IEC 60601-1-11:2015 IEC 2015 3 * Ingress of water or particulate matter into ME SYSTEMS 23 8.3.28.4 Additional requirements for interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT and ME SYSTEM . 23 8.5 Additional requirements for an INTERNAL ELECT

43、RICAL POWER SOURCE 24 * Indication of state 24 8.5.1Accessibility of small INTERNAL ELECTRICAL POWER SOURCEs . 25 8.5.29 Accuracy of controls and instruments and protection against hazardous outputs . 25 10 Construction of ME EQUIPMENT 25 10.1 * Additional requirements for mechanical strength . 25 G

44、eneral requirements for mechanical strength . 25 10.1.1* Requirements for mechanical strength for non-TRANSIT-OPERABLE 10.1.2ME EQUIPMENT 27 * Requirements for mechanical strength for TRANSIT-OPERABLE 10.1.3ME EQUIPMENT 28 10.2 Additional requirements for actuating parts of controls of ME EQUIPMENT

45、. 29 11 * Protection against strangulation or asphyxiation 30 12 Additional requirements for ELECTROMAGNETIC EMISSIONS of ME EQUIPMENT and ME SYSTEMS . 30 13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT and ME SYSTEMS . 30 13.1 * Additional requirement for generation of ALARM SIGNALS 30

46、 13.2 * Additional requirement for ALARM SIGNAL volume . 30 Annex A (informative) General guidance and rationale . 31 A.1 General guidance 31 A.2 Rationale for particular clauses and subclauses 32 Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS 51 B.

47、1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts 51 B.2 ACCOMPANYING DOCUMENTS, general 51 B.3 ACCOMPANYING DOCUMENTS, instructions for use 51 B.4 ACCOMPANYING DOCUMENTS, technical description 53 Annex C (informative) Symbols on marking 54 Bibliography 56 Index of defined terms us

48、ed in this collateral standard 58 Figure 1 Small finger probe 5,6 17 Figure A.1 Saturation water vapour pressure as function of temperature 36 Table 1 Mechanical strength test applicability, non-TRANSIT-OPERABLE . 26 Table 2 Mechanical strength test applicability, TRANSIT-OPERABLE 27 Table A.1 Satur

49、ation water vapour pressure as function of temperature . 37 Table A.2 Summary by use of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT ENCLOSURE ingress of water and particulate matter requirements 46 Table A.3 Qualitative assessment of HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT subjected to shock and vibration . 47 Table B.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts . 51 Table B.2 ACCOMPANYING DOCUMENTS, general . 51 Table B.3 ACCOMPANYING DOCUMENTS, instructions for use . 52 BS EN 6