1、Sterilization of health care products Chemical indicators Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs American National StandardANSI/AAMI/ISO 11140-5:2007/(R)2012The Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the object
2、ives and potential uses of 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 a
3、nd effective application 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 theseobj
4、ectives and provided that 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 cl
5、inical use, and the measurementtechniques 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,incl
6、uding performance characteristics, 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 specia
7、lized test methods to facilitateuniformity 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
8、 and the reasons for establishing 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 wi
9、ll help ensure that a device 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 frame of reference for device evaluation. Similar
10、ly, eventhough a recommended 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 gu
11、idelines to industrial personnel 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.I
12、n determining whether an AAMI 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 or
13、procurement authorities). 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
14、representatives, whose work 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
15、limited,however, in the sense 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
16、periodic review and revision (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 o
17、f itsprovisions. This review 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 o
18、rpotential risks with existing 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“.
19、 A voluntary standard can 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 an
20、dresources of the individual 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 wit
21、h other sources of informationand 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 TechnicalDevelopme
22、nt. An official interpretation 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 noti
23、ce of interpre-tation in the “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 wit
24、h this procedure and which is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI/ISO 11140-5:2007/(R)2012 (Revision of ANSI/AAMI ST66:1999) Sterilization of health care products Chemical indicatorsPart 5: Class 2 indicators for Bow
25、ie and Dick-type air removal tests Developed by Association for the Advancement of Medical Instrumentation Approved 12 April 2007 and reaffirmed 7 August 2012 by American National Standards Institute, Inc. Abstract: Specifies requirements for an indicator and alternative test system used to evaluate
26、 the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Keywords: apparatus, equilibrium, labeling, pack, packaging, performance, quality AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus
27、of those substantially concerned with its 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 stan
28、dard. AAMI standards are subject to periodic 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
29、 from the date of publication. Interested 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 i
30、s solely within the discretion and professional 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. P
31、ublished by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2007 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and A
32、AMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to mak
33、e copies of all or any part of this document (whether internally 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 permis
34、sion regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-570202915 Contents G
35、lossary of equivalent standards . iv Committee representation vi Background of AAMI adoption of ISO 11140-5:2007 . viii Foreword ix Introduction x 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 General requirements. 2 5 Indicator system 2 5.1 Format 2 5.2 Performance 2 6 Indicator
36、 . 3 6.1 Format 3 6.2 Performance 3 7 Packaging and labeling 4 8 Quality assurance . 4 9 Sampling conditioning . 4 Annex A (normative) Determination of the degree of contrast between the color of the substrate and the indicator agent . 5 Annex B (normative) Method of determining uniform color change
37、 on exposure to saturated steam 6 Annex C (normative) Method for determining indicator color change on exposure to dry heat. 7 Annex D (normative) Method for determining transfer of indicator agent to standard test pack 8 Annex E (normative) Standard test pack . 9 Annex F (normative) Method of deter
38、mining non-uniform color change on exposure to a standard fault condition . 10 Annex G (normative) Steam exposure apparatus. 12 Bibliography . 14 iv 2007 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11140-5:2007 Glossary of equivalent standards International Standards ado
39、pted 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. NOTE: Documents are
40、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/AAMI ES60601-1:2005 M
41、ajor technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC
42、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 60601-2-50:2001 ANSI/AAMI/I
43、EC 60601-2-50:2006 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 71
44、98:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2
45、006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002 and Amendment 1:2006 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical I
46、SO 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 and Amendment 1:2006 ANSI/AAMI BE78:2002 ANSI/AAMI BE78:2002/A1:2006 Minor technical variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identic
47、al 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/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical International designation U.S. designation Equiva
48、lency ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:
49、2006 Identical ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:2006 (2006-08-01 corrected version)ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:2006ANSI/AAMI/ISO 11137-3:2006 Identical ISO 11138-1: 2006 ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 2006 ANSI/AAMI/ISO 11138-2:2006 Identical ISO 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 11138-4:2006 Identical ISO 11138-5: 2006 ANSI/AAMI/ISO 11138-5:2006 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identic
