CAN CSA-C22 2 NO 60601-1-10 AMD 1-2014 Amendment 1 Medical electrical equipment - Part 1-10 General requirements for basic safety and essential performance Collateral Standard Req.pdf

1、 IEC 2013. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited. CEI 2013. Groupe CSA 2014. Tous droits rservs. Toute reproduction sans autorisation est strictement interdite.Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-10-09(IEC 60601110:2007, IDT)National St

2、andard of CanadaNorme nationale du CanadaModification 1:2014 (IDT) la CAN/CSA-C22.2 No. 60601-1-10-09Appareils lectromdicaux Partie 1-10 : Exigences gnrales pour lascurit de base et les performances essentielles Norme collatrale :Exigences pour le dveloppement des rgulateurs physiologiques en boucle

3、fermeAmendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-10-09Medical electrical equipment Part 1-10: General requirements for basicsafety and essential performance Collateral Standard: Requirements forthe development of physiologic closed-loop controllers(IEC 60601110:2007, IDT)Standards Update Ser

4、viceAmendment 1:2014 (IDT) to CAN/CSA-C22.2No. 60601-1-10-09December 2014Title: Medical electrical equipment Part 1-10: General requirements for basic safety andessential performance Collateral Standard: Requirements for the development ofphysiologic closed-loop controllersTo register for e-mail not

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6、at csagroup.org/legal to find out how we protect your personalinformation.Service de mise jour des normesModification 1:2014 (IDT) la CAN/CSA-C22.2No. 60601-1-10-09Dcembre 2014Titre : Appareils lectromdicaux Partie 1-10 : Exigences gnrales pour la scurit debase et les performances essentielles Norme

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9、rcomment nous protgeons vos renseignements personnels.IEC 60601-1-10 Edition 1.0 2013-11 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physio

10、logic closed-loop controllers Appareils lectromdicaux Partie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles Norme collatrale: Exigences pour le dveloppement des rgulateurs physiologiques en boucle ferme IEC60601-1-10:2007/A1:2013AMENDMENT 1 AMENDEMENT 1 THIS PUBLICAT

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25、NATIONALE Medical electrical equipment Part 1-10: General requirements for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers Appareils lectromdicaux Partie 1-10: Exigences gnrales pour la scurit de base et les performa

26、nces essentielles Norme collatrale: Exigences pour le dveloppement des rgulateurs physiologiques en boucle ferme INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040 AMENDMENT 1 AMENDEMENT 1 Registered trademark of the International Electrotechnical Commiss

27、ion Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-1-10 Amend. 1 IEC:2013 FOREWORD This amendm

28、ent 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, and ISO subcommittees SC1: Breathing attachments and anaesthetic machines, and SC3: Lung ventilators and related device

29、s of ISO technical committee 121: Anaesthetic and respiratory equipment. The text of this amendment is based on the following documents: FDIS Report on voting 62A/888/FDIS 62A/896/RVD Full information on the voting for the approval of this amendment can be found in the report on voting indicated in

30、the above table. In ISO, the standard has been approved by 15 P-members out of 15 having cast a vote. 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 site under “http:/webstore.iec.ch“ in t

31、he 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 first edition of IEC 60601-1-10 was published in 2007. This amendment is intended to update the references to IEC

32、60601-1:2005 to include Amendment 1:2012, to update IEC 60601-1-6:2006 to IEC 60601-1-6:2010, including its Amendment 1 and to update references to IEC 60601-1-8:2006 to include its Amendment 1:2012. This amendment also removes the normative reference to IEC 62304:2006. This collateral standard made

33、 reference to IEC 62304 because elements of the software process were not fully covered by Clause 14 of IEC 60601-1:2005. Amendment 1 to IEC 60601-1:2005 incorporates the needed software process requirement into Clause 14. Therefore, it is redundant and potentially confusing to have IEC 62304 explic

34、itly called out in this collateral standard. FOREWORD 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 may need a transitional period following publication of a new, amended or rev

35、ised IEC or ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 3 years

36、from the date of publication. Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-10-0960601-1-10 Amend. 1 IEC:2013 3 1 Scope, object and related standards 1.3.1 IEC 60601-1 Replace the existing first dashed item with: “the general standard“ designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012); R

37、eplace the existing second dashed item with: “this collateral standard“ designates IEC 60601-1-10 alone (IEC 60601-1-10:2007+A1:2013) 2 Normative references In the existing introductory paragraph, replace the first sentence with: The following documents, in whole or in part, are normatively referenc

38、ed in this document and are indispensable for its application. Replace the existing references 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 Amend

39、ment 1:2012 IEC 60601-1-6:2010, Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance Collateral standard: Usability Amendment 1:2013 IEC 60601-1-8:2006, Medical electrical equipment Part 1-8: General requirements for basic safety and essential perfor

40、mance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Amendment 1:2012 Delete the following normative reference: IEC 62304:2006, Medical device software Software life cycle processes Add the following norm

41、ative reference: IEC 62366:2007, Medical devices Application of usability engineering to medical devices 3 Terms and definitions Replace the existing introductory paragraph with: For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1:2012, IEC 60601-1-6:2010+ A1:20

42、13, IEC 60601-1-8:2006+A1:2012, IEC 62366:2007 and the following apply. 7 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) Replace the existing text of the clause with the following: Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-10-09 4 60601-1-10 Amend. 1 IEC:2013 For ME EQUIPMENT and ME SYST

43、EMS that incorporate a PCLC and incorporate PEMS, the requirements of Clause 14 of the general standard apply. Annex A General guidance and rationale A.2 Rationale for particular clauses and subclauses Subclause 5.1 Instructions for use In the existing first paragraph, replace “TRAINING (see IEC 606

44、01-1-6)“ with “training (see IEC 62366)“. Subclause 6.1 Usability In the existing first paragraph, in the first sentence replace “IEC 60601-1-6“ with “IEC 62366“, and in the penultimate sentence place “TRAINING“ in normal font. Clause 7 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) Replace the exis

45、ting text of the rationale with the following: Clause 7 of the first edition of this collateral standard applied the requirements of IEC 62304:2006 to the software elements of the PEMS. This was in addition to the requirement of Clause 14 of the general standard. Amendment 1 to the general standard

46、incorporates the software PROCESS requirements into Clause 14. Therefore, the additional requirements in Clause 7 of this collateral standard are redundant and can, in effect, be deleted. Subclause 8.1 General In the existing first paragraph, in the third sentence replace IEC 60601-1“ with “the gene

47、ral standard“, and in the last sentence replace “IEC 60601-1“ with “general standard“, and delete “or IEC 62304“. Subclause 8.2.2.4 Specification of operating conditions In the existing second dashed item, place “TRAINING“ in normal font. Index of defined terms used with this collateral standard Rep

48、lace the references to the following defined terms with: ALARM CONDITION IEC 60601-1-8:2006+A1:2012, 3.1 ESSENTIAL PERFORMANCE . IEC 60601-1:2005+A1:2012, 3.27 HAZARD IEC 60601-1:2005+A1:2012, 3.39 INTENDED USE IEC 60601-1:2005+A1:2012, 3.44 MANUFACTURER IEC 60601-1:2005+A1:2012, 3.55 NORMAL USE . I

49、EC 60601-1:2005+A1:2012, 3.71 OBJECTIVE EVIDENCE IEC 60601-1:2005+A1:2012, 3.72 PATIENT . IEC 60601-1:2005+A1:2012, 3.76 PROCESS . IEC 60601-1:2005+A1:2012, 3.89 RECORD . IEC 60601-1:2005+A1:2012, 3.98 RESIDUAL RISK IEC 60601-1:2005+A1:2012, 3.100 RISK IEC 60601-1:2005+A1:2012, 3.102 Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-10