CAN CSA-C22 2 NO 60601-1 AMD 1-2014 Amendment 1 Medical electrical equipment - Part 1-8 General requirements for basic safety and essential performance - Collateral standard Genera.pdf

1、 IEC 2012. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited. CEI 2012. Groupe CSA 2014. Tous droits rservs. Toute reproduction sans autorisation est strictement interdite.Amendment 1:2014 (IDT) toCAN/CSA-C22.2 No. 60601-1-8:08(IEC 60601-1-8:2006, IDT)National Sta

2、ndard of CanadaNorme nationale du CanadaModification 1:2014 (IDT) la CAN/CSA-C22.2 No. 60601-1-8:08Appareils lectromdicaux Partie 1-8 : Exigences gnrales pour la scurit de baseet les performances essentielles Norme collatrale : Exigences gnrales, essais etguide pour les systmes dalarme des appareils

3、 et des systmes lectromdicaux(IEC 60601-1-8:2006, IDT)Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-8:08Medical electrical equipment Part 1-8: General requirements for basic safety andessential performance Collateral standard: General requirements, tests andguidance for alarm systems in medica

4、l electrical equipment and medical electricalsystems(IEC 60601-1-8:2006, IDT)Standards Update ServiceAmendment 1:2014 (IDT) to CAN/CSA-C22.2No. 60601-1-8:08December 2014Title: Medical electrical equipment Part 1-8: General requirements for basic safety andessential performance Collateral standard: G

5、eneral requirements, tests and guidance foralarm systems in medical electrical equipment and medical electrical systemsTo register for e-mail notification about any updates to this publication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this

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7、1-1-8:08Dcembre 2014Titre : Appareils lectromdicaux Partie 1-8 : Exigences gnrales pour la scurit de baseet les performances essentielles Norme collatrale : Exigences gnrales, essais et guidepour les systmes dalarme des appareils et des systmes lectromdicauxVous devez vous inscrire pour recevoir les

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10、 Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Appareils lectromdicaux Partie 1-8: Exigences gnrales

11、 pour la scurit de base et les performances essentielles Norme collatrale: Exigences gnrales, essais et guide pour les systmes dalarme des appareils et des systmes lectromdicaux IEC60601-1-8:2006/A1:2012AMENDMENT 1 AMENDEMENT 1 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Swit

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25、 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 60601-1-8 Edition 2.0 2012-11 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 1-8: General req

26、uirements for basic safety and essential performance Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Appareils lectromdicaux Partie 1-8: Exigences gnrales pour la scurit de base et les performances essenti

27、elles Norme collatrale: Exigences gnrales, essais et guide pour les systmes dalarme des appareils et des systmes lectromdicaux INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.01 AMENDMENT 1 AMENDEMENT 1 Warning! Make sure that you obtained this publica

28、tion from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-1-8 Amend. 1 IEC:2012 FOREWORD This amendment has been prepared by subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC t

29、echnical committee 62: Electrical equipment in medical practice, and ISO subcommittee SC 3: Lung ventilators and related devices 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/824/FDIS 6

30、2A/837/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. In ISO, the standard has been approved by 19 P-members out of 21 having cast a vote. The committee has decided that the contents of this amendment and the b

31、ase publication will remain unchanged until the stability date indicated on the IEC web site 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 A

32、MENDMENT The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue has been identified with respect to pulse and burst testing. In addition, issues have been raised by IEC/62D/MT 22, Electromedical diagnostic and patient monitoring equipment, during implementation of

33、 alarm system requirements in particular standards within their scope of work. At the Brussels meeting, IEC/SC 62A accepted a proposal, based on ISO/TC 121/SC 3 Resolution Orebro 6, to develop the 1stamendment to IEC 60601-1-8:2006 to address the issues identified above. IEC/SC 62A ISO/TC 121/SC 3 J

34、oint Working Group 2, Alarms, was reactivated as a maintenance team to develop this amendment. 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 per

35、iod following publication of a new, amended or revised 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 m

36、andatory implementation nationally not earlier than 3 years from the date of publication. Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-8:0860601-1-8 Amend. 1 IEC:2012 3 1.2 Object In the first paragraph, change the print type of the defined terms “basic safety“ and “essential performance“ to

37、small caps. 1.3.1 IEC 60601-1 Replace the existing first dash with: “the general standard“ designates IEC 60601-1 alone (latest edition including any amendments); 2 Normative references Replace the introductory paragraph with: The following documents, in whole or in part, are normatively referenced

38、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. Replace the normative references for IEC 60417 and IEC 60601-1 with the followin

39、g: IEC 60417, Graphical symbols for use on equipment. Available from: IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance Amendment 1:2012 Delete the normative references for IEC 60601-1-2, and IEC 60601-1-6. Replace the normative re

40、ference to IEC 60651:1979 and its Amendment 1 (1993) and Amendment 2 (2000) with the following: IEC 61672-1:2002, Electroacoustics Sound level meters Part 1: Specifications Add the following normative reference: IEC 62366:2007, Medical devices Application of usability engineering to medical devices

41、Replace the normative references for ISO 3744:1994 and ISO 7000:1989 with the following: ISO 3744:2010, Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane ISO 7000, Grap

42、hical symbols for use on equipment. Available from: Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-1-8:08 4 60601-1-8 Amend. 1 IEC:2012 3 Terms and definitions Replace the existing first paragraph with the following: For the purposes of this document, the terms and definitions given in IEC 60601-

43、1:2005+A1:2012 and IEC 62366:2007, and the following terms and definitions apply. 3.1 * ALARM CONDITION Replace the existing definition with the following: state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS SITUATION exists for which OPERATOR awareness or response

44、is required NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION. NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION. Add the following new definition: 3.37 * ACKNOWLEDGED state of an ALARM SYSTEM initiated by OPERATOR action, where the auditory

45、 ALARM SIGNAL associated with a currently active ALARM CONDITION is inactivated until the ALARM CONDITION no longer exists NOTE 1 ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action. NOTE 2 ACKNOWLEDGED can terminate after a predetermined time interval has elap

46、sed. 6 Alarm systems 6.1 ALARM CONDITION 6.1.2 * ALARM CONDITION priority Replace the existing title and text of this subclause including Table 1 with the following: 6.1.2 * Determination of ALARM CONDITIONS and assignment of priority For each HAZARDOUS SITUATION where the MANUFACTURER has chosen to

47、 use an ALARM SYSTEM as a means of RISK CONTROL, the MANUFACTURER shall assign an ALARM CONDITION and its priority using Table 1. For HAZARDOUS SITUATIONS where the onset of potential HARM is delayed and the potential result of a failure to respond is discomfort or minor reversible injury, the MANUF

48、ACTURER may determine that no ALARM CONDITION is required. In such cases, the MANUFACTURER may implement an INFORMATION SIGNAL. NOTE Not all LOW PRIORITY ALARM CONDITIONS require prompt notification of the OPERATOR. On this basis an auditory ALARM SIGNAL or repeating auditory ALARM SIGNAL can be omi

49、tted, when appropriate, since the OPERATOR is expected to check the ME EQUIPMENT at intervals. In the event that the OPERATOR does not check the ME EQUIPMENT in a timely fashion, the ALARM CONDITION should escalate from LOW PRIORITY to MEDIUM PRIORITY or HIGH PRIORITY, and can additionally increase the sound pressure level of the related auditory A