1、 IEC 2013. CSA Group 2015. All rights reserved. Unauthorized reproduction is strictly prohibited. IEC 2013. Groupe CSA 2015. Tous droits rservs. Toute reproduction sans autorisation est strictement interdite.Amendment 1:2015 (IDT) toCAN/CSA-C22.2 No. 60601-1-6:11(IEC 60601-1-6:2010, IDT)National Sta
2、ndard of CanadaNorme nationale du CanadaModification 1:2015 (IDT) la CAN/CSA-C22.2 n 60601-1-6:11Appareils lectromdicaux Partie 1-6 : Exigences gnrales pour la scuritde base et les performances essentielles Norme collatrale : Aptitude lutilisation(IEC 60601-1-6:2010, IDT)Amendment 1:2015 (IDT) to CA
3、N/CSA-C22.2 No. 60601-1-6:11Medical electrical equipment Part 1-6: General requirements for basicsafety and essential performance Collateral standard: Usability(IEC 60601-1-6:2010, IDT)Standards Update ServiceAmendment 1:2015 (IDT) to CAN/CSA-C22.2No. 60601-1-6:11October 2015Title: Medical electrica
4、l equipment Part 1-6: General requirements for basic safety andessential performance Collateral standard: UsabilityTo regist er for e-mail notification about any updat es to this publication go to shop.csa.ca click on CSA Updat e ServiceThe List ID that you will need to regist er for updat es to thi
5、s publication is 2424274.If you require assista nce, please e-mail t echsupportcsagr oup.org or call 416-747-2233.Visit CSA Gr oups policy on privacy at www .csagr oup.org/legal to find out how we prot ect yourper sonal information.Service de mise jour des normesModification 1:2015 (IDT) la CAN/CSA-
6、C22.2n 60601-1-6:11Octobre 2015Titre : Appareils lectromdicaux Partie 1-6 : Exigences gnrales pour la scurit de baseet les performances essentielles Norme collatrale : Aptitude lutilisationVous devez vous inscrire pour recevoir les avis transmis par courriel au sujet des mises jour apporte s ce docu
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8、-747-2233.Consulte z la politique du Groupe CSA en matire de confidentialit au www .csagr oup.org/legal poursavoir comment nous prot geons vos renseignements per sonnels.IEC 60601-1-6 Edition 3.0 2013-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 1-6: General requi
9、rements for basic safety and essential performance Collateral standard: Usability Appareils lectromdicaux Partie 1-6: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Aptitude lutilisation IEC60601-1-6:2010/A1:2013AMENDMENT 1 AMENDEMENT 1 THIS PUBLICATION I
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17、new publications released. Available on-line and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French, with equivalent terms in additional langua
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20、vu. Veuillez vous assurer que vous possdez ldition la plus rcente, un corrigendum ou amendement peut avoir t publi. Liens utiles: Recherche de publications CEI - www.iec.ch/searchpub La recherche avance vous permet de trouver des publications CEI en utilisant diffrents critres (numro de rfrence, tex
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22、aussi une fois par mois par email. Electropedia - www.electropedia.org Le premier dictionnaire en ligne au monde de termes lectroniques et lectriques. Il contient plus de 30 000 termes et dfinitions en anglais et en franais, ainsi que les termes quivalents dans les langues additionnelles. Egalement
23、appel Vocabulaire Electrotechnique International (VEI) en ligne. Service Clients - webstore.iec.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-1-6 Edition 3.0 2013-10 INTERNATIONAL STANDARD NORME INTERNATION
24、ALE Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability Appareils lectromdicaux Partie 1-6: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Aptitude lutilisation INTERNATIONA
25、L ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE F ICS 11.040 PRICE CODE CODE PRIX AMENDMENT 1 AMENDEMENT 1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 60601-1-6 Amend.1 IEC:2013 FOREWOR
26、D This amendment has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC technical committee 62: Electrical equipment in medical practice. The text of this amendment is based on the following documents: FDIS Report on voting 62A/890/FDIS 62A/898
27、/RVD Full information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. The committee has decided that the contents of this amendment and the base publication will remain unchanged until the stability date indicated on the IEC web sit
28、e under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. _ INTRODUCTION TO THE AMENDMENT The third edition of IEC 60601-1-6 was published in 2010. The third edition create
29、d a bridge that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle process elements that are inconsistent with a
30、 TYPE TEST. This amendment is intended to clarify the elements of the USABILITY ENGINEERING PROCESS that are required for compliance with the IEC 60601 series. FOREWORD In the existing paragraph beginning “This document cancels and replaces“, delete the second sentence. In the existing third paragra
31、ph from the end of the Foreword, beginning “To assist the user“, replace “IEC 62366:2007“ with “IEC 62366:2007+A11)“ in two places. Add the following note at the end of the Foreword: NOTE The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations
32、 may need a transitional period following publication of a new, amended or revised IEC or 1)To be published. Amendment 1:2015 to CAN/CSA-C22.2 No. 60601-1-6:1160601-1-6 Amend.1 IEC:2013 3 ISO publication in which to make products in accordance with the new requirements and to equip themselves for co
33、nducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for mandatory implementation nationally not earlier than 3 years from the date of publication. INTRODUCTION In the first sentence of the fourth paragraph, replace “IEC 60601-1:200
34、5“ with “IEC 60601-1:2005+A1:2012“. In the second sentence of the existing sixth paragraph, replace “IEC 62366:2007“ with “IEC 62366“. Add, after the last paragraph of the introduction, the following new paragraph: Amendment 1 removes the reference to the complete life-cycle process (including post-
35、production monitoring and surveillance). IEC 60601 (the series) is confined to performing a TYPE TEST of ME EQUIPMENT. It does not extend to the entire life cycle including post-production monitoring and periodic maintenance of the USABILITY ENGINEERING PROCESS. 1.3.1 IEC 60601-1 Replace the existin
36、g first bullet with: “the general standard“ designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012); Replace the existing second bullet with: “this collateral standard“ designates IEC 60601-1-6 alone (IEC 60601-1-6:2010+A1:2013). 2 Normative references Replace the existing references to IEC 60601-1,
37、 IEC 60601-1-8 and IEC 62366 by the following new references: IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance Amendment 1:2012 IEC 60601-1-8:2006, Medical electrical equipment Part 1-8: General requirements for basic safety and e
38、ssential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Amendment 1:2012 IEC 62366:2007, Medical devices Application of usability engineering to medical devices Amendment 1:2)3 Terms and defin
39、itions In the existing introductory paragraph, replace “IEC 60601-1:2005“ with “IEC 60601-1:2005+A1:2012“, “IEC 60601-1-8:2006“ with “IEC 60601-1-8:2006+A1:2012“ and “IEC 62366:2007“ with “IEC 62366:2007+A1:2)“. 2)To be published. Amendment 1:2015 to CAN/CSA-C22.2 No. 60601-1-6:11 4 60601-1-6 Amend.
40、1 IEC:2013 4.2 * USABILITY ENGINEERING PROCESS for ME EQUIPMENT Replace the existing first paragraph with following: A USABILITY ENGINEERING PROCESS complying with IEC 62366:2007+A1: 3)shall be performed except: the planning for and execution of production and post-production monitoring in the conte
41、xt of applying the USABILITY ENGINEERING PROCESS within the framework of ISO 14971, and maintenance of the USABILITY ENGINEERING PROCESS. In the existing second paragraph, replace “IEC 60601-1:2005“ with “IEC 60601-1:2005+A1:2012“. 5 * Replacement of requirements given in IEC 62366 In the existing s
42、econd paragraph, replace “IEC 62366:2007“ with “IEC 62366:2007+A13). Annex A General guidance and rationale A.2 Rationale for particular clauses and subclauses Subclause 4.2 USABILITY ENGINEERING PROCESS for ME EQUIPMENT Replace the existing third paragraph of the rationale with the following: While
43、 the USABILITY ENGINEERING PROCESS described in IEC 62366 is more mature and refined than the PROCESS in the second edition of IEC 60601-1-6, it is fundamentally the same PROCESS. The scope of IEC 60601-1 and of this collateral standard is confined to performing a TYPE TEST of ME EQUIPMENT; it does
44、not extend to life-cycle monitoring. For this reason, the monitoring of production and post-production information and the planning thereof, as required by the ISO 14971 framework, is excluded from the USABILITY ENGINEERING PROCESS described in this standard. The requirement in IEC 62366 for periodi
45、c maintenance of the USABILITY ENGINEERING PROCESS is also excluded. In the existing fourth paragraph, replace “IEC 60601-1:2005“ with “IEC 60601-1:2005+A1:2012“. Clause 5 Replacement of requirements given in IEC 62366 In the existing first paragraph, replace “IEC 60601-1:2005“ with “IEC 60601-1:200
46、5+A1:2012“. Annex B Mapping between the elements of IEC 60601-1-6:2006 and the related elements in IEC 62366:2007 In the existing first paragraph, replace “IEC 62366:2007“ with “IEC 62366:2007+A13)in two places. Table B.1 Mapping between the elements of IEC 60601-1-6:2006 and the related elements in
47、 IEC 62366:2007 3)To be published. Amendment 1:2015 to CAN/CSA-C22.2 No. 60601-1-6:1160601-1-6 Amend.1 IEC:2013 5 In the existing title of the table, replace “IEC 62366:2007“ with “IEC 62366:2007+A1:3)“. Throughout the existing table, replace all occurrences of “IEC 60601-1:2005“ with “IEC 60601-1:2
48、005+A1:2012“, all occurrences of “IEC 60601-1-8:2006“ with “IEC 60601-1-8:2006+A1:2012“and all occurrences of “IEC 62366:2007“ with “IEC 62366:2007+A14)“. Insert, immediately preceding the row on “ 4 General requirements“, the following new row: 3.27 USER INTERFACE OF UNKNOWN PROVENANCE UOUP NOTE Am
49、endment 1 to IEC 62366 added a new term that was not in IEC 60601-1.6:2006. Insert, immediately following the row on “6.2.6 USABILITY VALIDATION“, the following new row: 5.10 USER INTERFACE OF UNKNOWN PROVENANCE (UOUP) NOTE Amendment 1 to IEC 62366 added a set of requirements when dealing WITH USER INTER
