CAN CSA-C22 2 NO 60601-2-44 AMD 1-2014 Amendment 1 Medical electrical equipment - Part 2-44 Particular requirements for the basic safety and essential performance of X-ray equipmen.pdf

1、Amendment 1Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomographyAmendement 1Appareils lectromdicaux Partie 2-44 : Exigences particulires pour la scurit de base et les performances essentielles des qui

2、pements rayonnement X de tomodensitomtrieAmendment 1:2014 (IDT) to National Standard of CanadaModification 1:2014 (IDT) la Norme nationale du CanadaCAN/CSA-C22.2 No. 60601-2-44-10(IEC 60601-2-44:2009, IDT) IEC 2012. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibite

3、d. CEI 2012. Groupe CSA 2014. Tous droits rservs. Toute reproduction sans autorisation est strictement interdite.Standards Update ServiceAmendment 1:2014 toCAN/CSA-C22.2 No. 60601-2-44-10September 2014Title: Medical electrical equipment Part 2-44: Particular requirements for the basic safety and ess

4、ential performance of X-ray equipment for computed tomographyPagination: 56 pages To register for e-mail notification about any updates to this publicationgo to shop.csa.caclick on CSA Update ServiceThe List ID that you will need to register for updates to this publication is 2423412.If you require

5、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 protect your personal information.Service de mise jour des normesModification 1:2014 laCAN/CSA-C22.2 n 60601-2-44-10Septembre 2014Titre : Appareils lectr

6、omdicaux Partie 2-44 : Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement X de tomodensitomtrieNombre de pages : 56 pages Vous devez vous inscrire pour recevoir les avis transmis par courriel au sujet des mises jour apportes ce document :allez a

7、u shop.csa.cacliquez sur Service de mises jour Le numro didentification dont vous avez besoin pour vous inscrire pour les mises jour apportes ce document est le 2423412.Si vous avez besoin daide, veuillez nous contacter par courriel au techsupportcsagroup.org ou par tlphone au 416-747-2233.Consultez

8、 la politique du Groupe CSA en matire de confidentialit au csagroup.org/legal pour savoir comment nous protgeons vos renseignements personnels.IEC 60601-2-44 Edition 3.0 2012-08 INTERNATIONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-44: Particular requirements for the basic

9、safety and essential performance of X-ray equipment for computed tomography Appareils lectromdicaux Partie 2-44: Exigences particulires pour la scurit de base et les performances essentielles des quipements rayonnement X de tomodensitomtrie IEC60601-2-44:2009/A1:2012AMENDMENT 1 AMENDEMENT 1 THIS PUB

10、LICATION IS COPYRIGHT PROTECTED Copyright 2012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise 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 writin

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14、2 11 3, rue de Varemb Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technolo

15、gies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Useful links: IEC publications search - www.iec.ch/searchpub The advanced search

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17、tails all 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 additio

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22、 ligne et 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.

23、Egalement 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 60601-2-44 Edition 3.0 2012-08 INTERNATIONAL STANDARD NORME

24、INTERNATIONALE Medical electrical equipment Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography Appareils lectromdicaux Partie 2-44: Exigences particulires pour la scurit de base et les performances essentielles des quipements

25、rayonnement X de tomodensitomtrie INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE U ICS 11.040.50 PRICE CODE CODE PRIX AMENDMENT 1 AMENDEMENT 1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique In

26、ternationale 2 60601-2-44 Amend.1 IEC:2012 FOREWORD This amendment has been prepared by subcommittee SC 62B: Diagnostic imaging equipment, 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 62

27、B/879/FDIS 62B/890/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

28、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 is drawn to the fact that equipment MANUFACTURERS and

29、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. It is the recommendation of the committee that the co

30、ntent of this publication be adopted for implementation nationally not earlier than 3 years from the date of publication. IMPORTANT The colour inside logo on the cover page of this publication indicates that it contains colours which are considered to be useful for the correct understanding of its c

31、ontents. Users should therefore print this document using a colour printer. _ Amendment 1:2014 to CAN/CSA-C22.2 No. 60601-2-44-1060601-2-44 Amend.1 IEC:2012 3 Introduction to Amendment 1 The main topic addressed in this amendment is an extended concept of CTDI to accommodate CT SCANNERS with very la

32、rge z-coverage. The other principal subject areas include: 1) a dose-check feature associated with a pre-scanning alert if expected values of dose indices exceed user-configurable DOSE NOTIFICATION VALUES or DOSE ALERT VALUES and 2) requirements covering the use of CT data in radiotherapy treatment

33、planning (RTP). The CT dose metric in use has been based on the CTDI100, i.e. measurement of dose in PHANTOMs and limited integration of scattered radiation, and it is used in many countries legislation to define “dose reference values“ (also called “diagnostic reference levels“) for CT examinations

34、. Many people use these indices, CTDIvoland DLP, to derive estimates for effective dose via conversion factors. CTDI100is also part of CT acceptance and constancy testing. The introduction of a new dose index would change all CT SCANNERS CTDI values. Therefore the intention is to stay with the CTDI1

35、00, i.e. the integration of primary radiation and scatter over 100 mm, but adapt the way of measuring and reporting the dose index to incorporate large collimations and to rate all collimations the same way, i.e. to reflect approximately the same percentage of CTDIfor all collimations. As defined in

36、 the amendment, CTDI100is to be measured only for collimations up to 40 mm with the current equipment, i.e. the PMMA PHANTOMs and a 100-mm chamber, or other suitable methods that use a RADIATION DETECTOR. For these collimations there is no significant change of the ratio CTDI100/ CTDIaccording to pu

37、blished data. For larger collimations at the same CT CONDITIONS OF OPERATION, the z-efficiency may be different and must be evaluated in the dose measurement. This can be accomplished by the measurement of dose free air. Based on these considerations CTDI100and the CTDIfree air have been refined. Bo

38、th types of measurement are combined now to determine the CTDI values for larger collimations and they are explained in detail in informative Annexes CC and DD. Some additional requirements and refinements related to dose have been added: CTDIvoland DLP are defined for a new type of scan mode (shutt

39、le mode). In body CT EXAMINATION it is clarified that the CTDIvoland DLP always be reported for the 32-cm diameter PHANTOM. In the amendment it is now required that CT SCANNERS support user-configurable DOSE NOTIFICATION VALUES and DOSE ALERT VALUES. A new subject area in this Amendment 1 covers req

40、uirements for CT SCANNERS providing images for radiotherapy treatment planning. With this amendment begins the implementation of this important CT application into the CT safety standard with a set of requirements that is considered to be safety relevant. It mainly covers scanner hardware adjustment

41、s, accuracy of CT image data, and the conversion of HU to electron and mass density. Amendment 1:2014 to CAN/CSA-C22.2 No. 60601-2-44-10 4 60601-2-44 Amend.1 IEC:2012 201.1.1 Scope Add the following new sentence: The scope of this International Standard excludes RADIOTHERAPY SIMULATORS and systems w

42、here the image is created by a source other than an X-RAY TUBE. 201.1.3 Collateral standards Replace the existing text of this subclause with the following: Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clau

43、se 201.2 of this particular standard. IEC 60601-1-2 and IEC 60601-1-3 apply as modified in Clauses 202 and 203. IEC 60601-1-8, IEC 60601-1-9, IEC 60601-1-101), IEC 60601-1-112)and IEC 60601-1-123)do not apply. All other published collateral standards in the IEC 60601-1 series apply as published. For

44、 collateral standards published after this particular standard, MANUFACTURERS need to determine the applicability in accordance with the RISK MANAGEMENT PROCESS. 201.2 Normative references Add, under “Replacement“, the following new reference: IEC 60601-1-2:2007, Medical electrical equipment Part 1-

45、2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests Add, under “Addition“, the following new reference: IEC 60336 Medical electric equipment X-Ray Tube assemblies for medical diagnosis Characteristics of focal s

46、pots 201.3 Terms and definitions 201.3.202 CT CONDITIONS OF OPERATION Add a note 3 to this definition: NOTE 3 CT CONDITIONS OF OPERATION include parameters that are derived by the system from the user-selectable parameters. _ 1)IEC 60601-1-10, Medical electrical equipment Part 1-10: General requirem

47、ents for basic safety and essential performance Collateral Standard: Requirements for the development of physiologic closed-loop controllers 2)IEC 60601-1-11, Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance Collateral Standard: Requirements for

48、 medical electrical equipment and medical electrical systems used in the home healthcare environment 3)IEC 60601-1-12, Medical electrical equipment Part 1-12: General requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medica

49、l electrical systems intended to be used in the emergency medical services environment Amendment 1:2014 to CAN/CSA-C22.2 No. 60601-2-44-1060601-2-44 Amend.1 IEC:2012 5 201.3.203 COMPUTED TOMOGRAPHY DOSE INDEX 100 CTDI100 Replace the existing text of the definition by the following: integral of the DOSE PROFILE representative of a single axial scan