CAN CSA-C22 2 NO 60601-2 AMD 1-2014 Amendment 1 Medical electrical equipment - Part 2-22 Particular requirements for basic safety and essential performance of surgical cosmetic the.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) to CAN/CSA-C22.2 No. 60601-2-22:08(IEC 60601222:2007, IDT)National St

2、andard of CanadaNorme nationale du CanadaModification 1:2014 (IDT) la CAN/CSA-C22.2 No. 60601-2-22:08Appareils lectromdicaux Partie 2-22 : Rgles particulires pour lascurit de base et les performances essentielles des appareils chirurgicaux,esthtiques, thrapeutiques et de diagnostic laser(IEC 6060122

3、2:2007, IDT)Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-2-22:08Medical electrical equipment Part 2-22: Particular requirements for basicsafety and essential performance of surgical, cosmetic, therapeutic anddiagnostic laser equipment(IEC 60601222:2007, IDT)Standards Update ServiceAmendment 1:2

4、014 (IDT) to CAN/CSA-C22.2No. 60601-2-22:08December 2014Title: Medical electrical equipment Part 2-22: Particular requirements for basic safetyand essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipmentTo register for e-mail notification about any updates to this publ

5、ication go to shop.csa.ca click on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2423640.If you require assistance, please e-mail techsupportcsagroup.org or call 416-747-2233.Visit CSA Groups policy on privacy at csagroup.org/legal to find out how we

6、 protect your personalinformation.Service de mise jour des normesModification 1:2014 (IDT) la CAN/CSA-C22.2No. 60601-2-22:08Dcembre 2014Titre : Appareils lectromdicaux Partie 2-22 : Rgles particulires pour la scurit debase et les performances essentielles des appareils chirurgicaux, esthtiques, thra

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9、60601-2-22 Edition 3.0 2012-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Appareils lectromdicaux Partie 2-22: Rgles particuli

10、res pour la scurit de base et les performances essentielles des appareils chirurgicaux, esthtiques, thrapeutiques et de diagnostic laser IEC60601-2-22:2007/A1:2012AMENDMENT 1 AMENDEMENT 1 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless othe

11、rwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National Committee in the country of the requester. If you have any que

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24、c.ch/csc Si vous dsirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csciec.ch. IEC 60601-2-22 Edition 3.0 2012-10 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-22: Particular requirements for basic safety and esse

25、ntial performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Appareils lectromdicaux Partie 2-22: Rgles particulires pour la scurit de base et les performances essentielles des appareils chirurgicaux, esthtiques, thrapeutiques et de diagnostic laser INTERNATIONAL ELECTROTECHNI

26、CAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.01, 31.260 AMENDMENT 1 AMENDEMENT 1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale Warning! Make sure that you obtained this publication from an a

27、uthorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agr. 2 60601-2-22 Amend. 1 IEC:2012 FOREWORD This amendment has been prepared by IEC technical committee 76: Optical radiation safety and laser equipment. The text of this amendment is

28、based on the following documents: CDV Report on voting 76/444/CDV 76/477/RVC 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 wil

29、l 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. NOTE The attention of National Committees

30、is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests.

31、 It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 12 months from the date of publication. _ 201.3 Terms and definitions Replace the existing first sentence by the following: For the purposes of this document, the

32、 terms and definitions given in IEC 60601-1:2005 and IEC 60825-1:2007 apply, except as follows: 201.8.5 Separation of parts Amendment: Replace the existing second sentence of the amendment by the following: This exemption applies to the requirements of subclauses 8.6, 8.8 and 8.9 for MEANS OF OPERAT

33、OR PROTECTION: it does not apply to MEANS OF PATIENT PROTECTION. Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-2-22:08 60601-2-22 Amend. 1 IEC:2012 3 201.8.7.3 * Allowable values Replace the existing addition by the following: Laser equipment is considered as PERMANENTLY INSTALLED equipment if:

34、It is connected to the SUPPLY MAINS by means of a MAINS PLUG which is mechanically secured against unintentional loosening, and the POWER SUPPLY CORD is non-detachable, and the cross-sectional area of the POWER SUPPLY CORD conductors are not less than 2,5 mm2Cu, and the residual risk that the LEAKAG

35、E CURRENT is in excess of the limits specified in the general standard and may flow through the PATIENT or OPERATOR/USER, is explicitly justified in the RISK MANAGEMENT FILE. Compliance is checked by inspection of the risk management file 201.8.11.101 Use of water for cooling Replace the existing te

36、xt of the subclause by the following: Where liquid is used in LASER EQUIPMENT for cooling and where the liquid assumes the task of BASIC INSULATION to SUPPLY MAINS, the conductivity of the liquid shall be such that the leakage current values required in 8.9 of the general standard are not exceeded i

37、n NORMAL USE. The conductivity of the liquid shall be continuously monitored by the LASER EQUIPMENT. In case of leakage current exceeding the values required in 8.9 of the general standard as a result of increased liquid conductivity, the LASER EQUIPMENT shall be switched off automatically from the

38、SUPPLY MAINS. Compliance is checked by inspection and functional tests Annex AA Particular guidance and rationale AA.2 Rationale for particular clauses and subclauses Subclause 201.8.7.3 Add the following new paragraph: The RISK MANAGEMENT FILE may consider technical means such as isolation of APPLI

39、ED PARTS; the ruggedness of the mains cable against interruption of the protective earth; the use of certified industrial plugs; cautious handling information of the laser equipment in the instructions for use; monitoring of the integrity of the PROTECTIVE EARTH CONNECTION. _ Amendment 1:2014 (IDT)

40、to CAN/CSA-C22.2 No. 60601-2-22:08 4 60601-2-22 Amend. 1 CEI:2012 AVANT-PROPOS Le prsent amendement a t tabli par le comit dtudes 76 de la CEI: Scurit des rayonnements optiques et matriels laser. Le texte de cet amendement est issu des documents suivants: CDV Rapport de vote 76/444/CDV 76/477/RVC Le

41、 rapport de vote indiqu dans le tableau ci-dessus donne toute information sur le vote ayant abouti lapprobation de cet amendement. Le comit a dcid que le contenu de cet amendement et de la publication de base ne sera pas modifi avant la date de stabilit indique sur le site web de la CEI sous “http:/

42、webstore.iec.ch“ dans les donnes relatives la publication recherche. A cette date, la publication sera reconduite, supprime, remplace par une dition rvise, ou amende. NOTE Lattention des Comits Nationaux est attire sur le fait que les fabricants dappareils et les organismes dessai peuvent avoir beso

43、in dune priode transitoire aprs la parution dune nouvelle publication CEI, ou dune publication amende ou rvise, pour fabriquer des produits conformes aux nouvelles exigences et pour adapter leurs quipements aux nouveaux essais ou aux essais rviss. Le comit recommande que le contenu de cette publicat

44、ion soit entrin au niveau national au plus tt 12 mois aprs la date de publication. _ 201.3 Termes et dfinitions Remplacer la premire phrase existante par la suivante: Pour les besoins du prsent document, les termes et les dfinitions de la CEI 60601-1:2005 et de la CEI 60825-1:2007 sappliquent, avec

45、les exceptions suivantes: 201.8.5 Sparation des parties Amendement: Remplacer la deuxime phrase existante de lamendement par la suivante: Cette exemption sapplique aux exigences des paragraphes 8.6, 8.8 et 8.9 pour les MOYENS DE PROTECTION DE LOPRATEUR; elle ne sapplique pas pour les MOYENS DE PROTE

46、CTION DU PATIENT. Modification 1:2014 (IDT) la CAN/CSA-C22.2 n 60601-2-22:08 60601-2-22 Amend. 1 CEI:2012 5 201.8.7.3 * Valeurs admissibles Remplacer laddition existante par la suivante: Un appareil laser est considr comme un appareil INSTALL DE FAON PERMANENTE: sil est connect au RSEAU DALIMENTATIO

47、N au moyen dune FICHE RSEAU fixe mcaniquement pour viter toute dconnexion accidentelle, et si le CBLE DALIMENTATION nest pas dtachable, et si la section des conducteurs du CBLE DALIMENTATION nest pas infrieure 2,5 mm2Cu, et si le risque rsiduel que le COURANT DE FUITE soit suprieur aux limites spcif

48、ies dans la norme gnrale et peut circuler travers le patient ou loprateur/utilisateur, est justifi de manire explicite dans le DOSSIER DE GESTION DES RISQUES. La conformit est vrifie par inspection du dossier de gestion des risques. 201.8.11.101 Utilisation de leau pour le refroidissement Remplacer le texte existant du paragraphe par le suivante: Lorsque lon utilise du liquide pour le refroidissement des APPAREILS LASER et que le liquide assure le rle dISOLATION PRINCIPALE vis vis du RSEAU DALI