EN 60601-1-10-2008 en Medical electrical equipment - Part 1-10 General requirements for basic safety and essential performance - Collateral Standard Requirements for the developmen.pdf

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1、BRITISH STANDARDBS EN 60601-1-10:2008Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllersICS 11.040.10 BS EN 60601-1-10:2008 +A1:2015BS EN 60601-1-10:2008+A

2、1:2015ISBN 978 0 580 80619 3Amendments/corrigenda issued since publicationDate Comments30 June 2015 Implementation of IEC amendment 1:2013 with CENELEC endorsement A1:2015. Annex ZA updatedThis British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 Au

3、gust 2008 The British Standards Institution 2015. Published by BSI Standards Limited 2015National forewordThis British Standard is the UK implementation of EN 60601-1-10:2008+A1:2015. It is identical to IEC 60601-1-10:2007 incorporating amendment 1:2013. It supersedes BS EN 60601-1-10:2008, which wi

4、ll be withdrawn on 31 December 2018.The start and finish of text introduced or altered by amendment is indicated in the text by tags.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 p

5、reparation was entrusted by Technical Committee CH/62, Electrical Equipment in Medical Practice 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.This publicati

6、on 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 immunity from legal obligations.EUROPEAN STANDARD EN 60601-1-10NORME EUROPENNE EUROPISCHE NORMApril 2008CENELEC European Commi

7、ttee forElectrotechnicalStandardization Comit Europen de Normalisation ElectrotechniqueEuropisches Komitee fr Elektrotechnische NormungCentral Secretariat:rue de Stassart35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELECmembers

8、.Ref. No. EN 60601-1-10:2008 EICS 11.040 English versionMedical electricalequipment - Part 1-10: General requirements for basic safetyand essential performance -Collateral Standard: Requirements for the development of physiologic closed-loop controllers(IEC 60601-1-10:2007)Appareils lectromdicaux -P

9、artie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles -Norme collatrale: Exigencespour ledveloppement des rgulateurs physiologiques en boucle ferme(CEI 60601-1-10:2007)Medizinische elektrische Gerte -Teil 1-10: Allgemeine Festlegungen fr die Sicherheit einschlielich d

10、er wesentlichen Leistungsmerkmale -Ergnzungsnorm: Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen(IEC 60601-1-10:2007)This European Standard was approved by CENELEC on 2008-03-01. CENELEC members are bound to complywith the CEN/CENELEC Internal Regulations which stipu

11、late 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 onapplication to the Central Secretariat or to any CENELEC member. This European Standard

12、 exists in three official versions (English, French, 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 ele

13、ctrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, theCzech 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, Switzer

14、land and the United Kingdom.EN 60601-1-10:2008+A1May 2015Foreword The text of document 62A/576/FDIS, future edition 1of IEC 60601-1-10, prepared by SC 62A, Commonaspects of electrical equipment used in medical practice, of IEC TC 62, Electrical equipment in medical practice, and ISO SC 1, Breathing

15、attachments and anaesthetic machines, and SC 3, Lung ventilators and related devices, of ISO TC 121, Anaesthetic and respiratory equipment, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC asEN 60601-1-10 on 2008-03-01The following dates were fixed: latest date by which the

16、 EN has to be implemented at national level by publication of an identicalnational standard or by endorsement(dop) 2008-12-01 latest date by which the national standards conflictingwith the EN have to be withdrawn (dow) 2011-03-01This European Standardhas been prepared under a mandate given to CENEL

17、EC by the European Commission and the European Free Trade Association and covers essential requirements ofEC Directive 93/42/EEC. See Annex ZZ.This European Standard constitutes a collateral standard to EN 60601-1:2006, hereafter referred to asthe general standard.In the 60601 series of publications

18、, collateral standards specify general requirements for safety applicableto: a subgroup of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment); or a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT, not fullyaddressed in the generalstandard (e.g. ALARM SYSTEMS). In this collateral

19、standard, the following print types are used: requirements and definitions: in roman type; testspecifications: in italic type; informative material appearing outside oftables,such as notes, examples and references: in smaller type. Normative text oftables is also in a smaller type; TERMS DEFINED IN

20、CLAUSE 3 OF THE GENERALSTANDARD, IN THIS COLLATERAL STANDARD OR AS NOTED: INSMALL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the eight numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 8 includes Subclauses 8.1,

21、8.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 8.1, 8.2 and 8.2.1 are all subclauses of Clause 8).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 th

22、is standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.BS EN 60601-1-10:2008 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

23、, the auxiliary verb “shall” means that compliance with a requirement or a test is mandatory for compliance with thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standard; “may”is used to describe a permissible way

24、to achieve compliance with a requirement or test. Clauses, subclauses 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 noticeThe text of the International Standard IEC 60601-1-10:2007 w

25、asapproved byCENELEC as a European Standard without any modification._BS EN 60601-1-10:2008 3 - 2 -BS EN 60601-1-10:2008+A1:2015The 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

26、” means that compliance with a requirement or a test is mandatory for compliance with thisstandard; “should” means that compliance with a requirement or a test is recommended but is not mandatory forcompliance with this standard; “may”is used to describe a permissible way to achieve compliance with

27、a requirement or test. Clauses, subclauses 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 noticeThe text of the International Standard IEC 60601-1-10:2007 wasapproved byCENELEC as a E

28、uropean Standard without any modification._BS EN 60601-1-10:2008 3 - 3 - BS EN 60601-1-10:2008+A1:2015EN 60601-1-10:2008/A1:2015 2 Foreword The text of document 62A/888/FDIS, future IEC 60601-1-10:2007/A1, prepared by SC 62A “Common aspects of electrical equipment used in medical practice“ of IEC/TC

29、 62 “Electrical equipment in medical practice“ and ISO/SC 1 “Breathing attachments and anaesthetic machines“ and ISO/SC 3 “Lung ventilators and related devices“ of ISO/TC 121 “Anaesthetic and respiratory equipment“ was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-1-

30、10:2008/A1:2015. 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

31、 (dow) 2018-12-31 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 CENELEC by

32、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 60601-1-10:2008. Endorsement notice The text of the International Standard IEC 60601-1-10:2

33、007/A1:2013 was approved by CENELEC as a European Standard without any modification. Foreword to amendment A1Annex ZA(normative)Normative references to international publicationswith their corresponding European publications The following referenced documents are indispensable for the application of

34、 this document. For dated references, onlythe edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HDapplie

35、s.Publication Year Title EN/HD YearIEC 60601-1 2005 Medical electrical equipment -Part 1: General requirements for basic safetyand essential performance EN 60601-12006IEC 60601-1-62006 Medical electrical equipment -Part 1-6: General requirements for basicsafety and essential performance - Collateral

36、 Standard: Usability EN 60601-1-62007IEC 60601-1-82006 Medical electrical equipment -Part 1-8: General requirements for basicsafety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electricalsystems

37、EN 60601-1-82007IEC 62304 2006 Medical device software - Software life-cycle processesEN 623042006ISO 14971 -1)Medical devices - Application of riskmanagement to medical devicesEN ISO 14971 20072)1)Undated reference.2)Valid edition at date of issue.BS EN 60601-1-10:2008 39 - 4 -BS EN 60601-1-10:2008

38、+A1:2015EN 60601-1-10:2008/A1:2015 3 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 its application. For dated r

39、eferences, 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 applies. NOTE 2 Up-to-date i

40、nformation on the latest versions of the European Standards listed in this annex is available here: www.cenelec.eu Modifications in Annex ZA of EN 60601-1-10:2008: Publication Year Title EN/HD Year Replace the existing references to IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-8 by the following new r

41、eferences: IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 + corr. March 2006 2010 +A1 2012 +A1 +A1/AC 2013 2014 +A12 2014 IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: General requirements for basic saf

42、ety and essential performance - Collateral standard: Usability EN 60601-1-6 2010 +A1 2013 +A1 2015 IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm sys

43、tems in medical electrical equipment and medical electrical systems EN 60601-1-8 + corr. March 2007 2010 +A1 2012 +A1 +A1/AC 2013 2014 Delete the following reference: IEC 62304 2006 Medical device software - Software life-cycle processes EN 62304 2006 Add the following reference: IEC 62366 2007 Medi

44、cal devices - Application of usability engineering to medical devices EN 62366 2008 EN 60601-1-10:2008/A1:2015 3 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively refere

45、nced 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 Publication has been modified by common modifi

46、cations, 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 Modifications in Annex ZA of EN 60601-1-10:2008: Publication Year Title EN/HD Year Replace the existing refer

47、ences to IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-8 by the following new references: IEC 60601-1 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1 + corr. March 2006 2010 +A1 2012 +A1 +A1/AC 2013 2014 +A12 2014 IEC 60601-1-6 2010

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

49、 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8 + corr. March 2007 2010 +A1 2012 +A1 +A1/AC 2013 2014 Delete the following reference: IEC 62304 2006 Medical device software - Software life-cycle processes EN 62304 2006 Add the following reference: IE