ANSI AAMI 11137-3-2006 Sterilization of health care products-Radiation-Part 3 Guidance on dosimetric aspects.pdf

1、Association for the Advancementof Medical InstrumentationANSI/AAMI/ISO 11137-3:2006/(R)2010Sterilization of health careproductsRadiationPart 3: Guidance ondosimetric aspectsThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential uses o

2、f an AAMIproduct standard or recommended practice are clearly understood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective application

3、of current technologiesto patient care, and (2) the encouragement of new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided that

4、 arbitrary and restrictive uses are avoided.A voluntary standard for a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical use, and the measu

5、rementtechniques that can be used to determine whether the device conformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including performance charact

6、eristics, instructions for use, warningsand precautions, and other data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized test methods to fac

7、ilitateuniformity in reporting; reaching consensus on these tests canrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for esta

8、blishing the criteria must bedocumented in the rationale.A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a dev

9、ice is usedsafely and effectively and that its performance will be maintained.Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device evaluation. Similarly, eventhough a recommend

10、ed practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial per

11、sonnel onsuch subjects as sterilization processing, methods of collecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.In determining whether an A

12、AMI standard or recommendedpractice is relevant to the specific needs of a potential user of thedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authorities).

13、The application of a standard or recom-mended practice is solely within the discretion and professionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose wor

14、k has been reviewed nationally(and sometimes internationally). As such, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in the se

15、nse that it responds generally to perceived risks andconditions that may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecision-making.Despite periodic review and revisi

16、on (at least once every fiveyears), a standard or recommended practice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This revi

17、ew will reveal whether the document remainsrelevant to the specific needs of the user.Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with exis

18、ting equipment typically form the basis for thesafety and performance criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as “unsafe“. A voluntary standard can

19、be used asone resource, but the ultimate decision as to product safety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the individu

20、al institution or firm. Again, the rationaleaccompanying each AAMI standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of informa

21、tionand policy guidance and in the context of professional experience andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpreta

22、tion must be approved by letterballot of the originating committee and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon publication of notice of interpre-tation in t

23、he “Standards Monitor“ section of the AAMI News. TheAssociation for the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicated in accordance with this procedure and which

24、 is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI/ISO 11137-3:2006/(R)2010 (Combined revision in whole or in part of ANSI/AAMI/ISO 11137:1994 and A1:2002 and AAMI TIR29:2002) Sterilization of health care productsRadiation Part

25、 3: Guidance on dosimetric aspects Approved 9 December 2005 by Association for the Advancement of Medical Instrumentation Approved 23 December 2005 and Reaffirmed 20 April 2010 by American National Standards Institute Abstract: Guidance on dosimetry for radiation sterilization of health care product

26、s. Keywords: health care products, medical equipment, sterilization, radiation, gamma, electron beam, bremsstrahlung, x-ray, dosimeter, dosimetry AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with it

27、s scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standards are subject to peri

28、odic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Intereste

29、d parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and profe

30、ssional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancem

31、ent of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2006 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or di

32、stributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this draft should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether inter

33、nally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document,

34、 contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570202559 Contents Page Glossary of equivalent standards . iv Committee representation vi Background of AAMI adoption of ISO 11137-3:2006

35、. ix Foreword. x Introduction . xi 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Measurement of dose . 1 5 Selection and calibration of dosimetry systems . 2 5.1 General. 2 5.2 Selection of dosimetry systems 2 5.3 Calibration of dosimetry system . 2 6 Establishing the maximum acc

36、eptable dose . 2 7 Establishing the sterilization dose 3 8 Installation qualification. 4 9 Operational qualification 5 9.1 General. 5 9.2 Gamma irradiators 5 9.3 Electron beam irradiators 6 9.4 X-ray irradiators 8 10 Performance qualification 9 10.1 General. 9 10.2 Gamma and X-ray 10 10.3 Electron b

37、eam . 11 11 Routine monitoring and control 12 11.1 General. 12 11.2 Frequency of dose measurements 12 Annex A (informative) Mathematical modelling 13 Bibliography . 16 iv 2006 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11137-3:2006 Glossary of equivalent standards Inter

38、national Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard

39、. Note: Documents are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI

40、/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variatio

41、ns IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC TR 60878:2003 ANSI/A

42、AMI/IEC TIR60878:2003 Identical IEC TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC TR 62348:200x1 ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002

43、Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:1992 ANSI/AAMI/ISO 10993-2:1993/(R)2001 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 ANSI/AAMI/ISO 10993-4:2002 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:

44、1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 ANSI/AAMI BE78:2002 Minor technical variations ISO 10993-11:1993 ANSI/AAMI 10993-11:1993 Minor technical var

45、iations ISO 10993-12:2002 ANSI/AAMI/ISO 10993-12:2002 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identi

46、cal ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO TS 10993-19:200x1ANSI/AAMI/ISO TIR10993-19:2006 Identical 2006 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11137-3:2006 v International design

47、ation U.S. designation Equivalency ISO TS 10993-20:200x1ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:200x1 ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:2006ANSI/AAMI/ISO 11137-3:2006 Id

48、entical ISO 11138-1: 200x1ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 200x1ANSI/AAMI/IS 11138-2:2006 Identical ISO 11138-3: 200x1ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 200x1ANSI/AAMI/IS 11138-4:2006 Identical ISO 11138-5: 200x1ANSI/AAMI/ISO 11138-5:2006 Identical ISO TS 11139:2006 A

49、NSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-5:2000 ANSI/AAMI ST66:1999 Major technical variations ISO 11607-1:2006ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 11737-3:2004 ANSI/AAMI/ISO 11737-3:2004 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 13488:1996 ANSI/AAMI/ISO 13488:1996 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003 Identical