1、ANSI/AAMI/ISO 11138-3: 2017Sterilization of health care productsBiological indicatorsPart 3: Biological indicators for moist heat sterilization processesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential us
2、es of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective app
3、lication of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and
4、 provided that arbitrary and restrictive uses are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical us
5、e, and the measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including pe
6、rformance characteristics, instructions for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialize
7、d test methods to facilitate uniformity in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provide
8、d and the reasons for establishing the criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices t
9、hat will help ensure that a device is used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation.
10、 Similarly, even though a recommended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria
11、, provide guidelines to industrial personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding indust
12、rial practices. In determining whether an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by gov
13、ernment regulatory or procurement authorities). The application of a standard or recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care prof
14、essionals and industrial representatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standar
15、d or recommended practice is limited, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace re
16、sponsible decision-making. Despite periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially develope
17、d and the specific rationale for each of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to curren
18、t procedures and practices. While observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serv
19、e to identify a particular product as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should
20、be analyzed in the context of the specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice
21、 is truly useful only when it is used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices
22、must be made in writing, to the AAMI Vice President, Standards Policy and Programs. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation
23、 of the Association only upon exhaustion of any appeals and upon publication of notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard
24、or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/ISO 11138-3:2017 (Revision of ANSI/AAMI/ISO 11138-3:2006/(R)
25、2015 Sterilization of health care productsBiological indicatorsPart 3: Biological indicators for moist heat sterilization processes Approved 14 April 2017 by AAMI Approved 1 August 2017 by American National Standards Institute Abstract: Specifies requirements for test organisms, suspensions, inocula
26、ted carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Keywords: carrier, organism, resistance, packaging, value 2 2017 Association for the Advancement of Medical Instrumentation ANS
27、I/AAMI/ISO 11138-3:2017 AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus 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 appro
28、ved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. 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 w
29、ithdrawn 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. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended
30、 practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regula
31、tory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI 4301 N. Fairfax Dr., Suite. 301 Arlington, VA 22203-1633 www.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All
32、Rights Reserved This publication is subject to copyright claims of ISO and AAMI. 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 submit
33、ted 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 internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including c
34、ivil and criminal penalties, and damages of $100,000 per offense. For permission 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: (703) 525-4890; Fax: (703) 276
35、-0793. Printed in the United States of America ISBN 978-1-57020-680-1 Contents Page Glossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 11138-3:2017 . vii Foreword viii Introduction . ix 1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4
36、General requirements . 1 5 Test organism 1 6 Suspension 2 7 Carrier and primary packaging 2 8 Inoculated carriers and biological indicators . 2 9 Population and resistance 2 Annex A (normative) Method for determination of resistance to moist heat sterilization 4 Annex B (normative) Calculation of z
37、value and coefficient of determination, r2 . 5 Bibliography . 9 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-3:2017 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International
38、Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glos
39、sary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-3:2017 v Committee representation Association for the Advancement of Medical Instrumentation Biological Indicators Working Group The adoption of ISO 11138-3:2017 as an American National Standard was initiate
40、d by the AAMI Biological Indicators Working Group of the AAMI Sterilization Standards Committee. U.S. representatives from the AAMI Biological Indicators Working Group played an active part in developing the ISO standard. At the time this document was published, the AAMI Biological Indicators Workin
41、g Group had the following members: Cochairs: Anthony Piotrkowski Craig Wallace Members: Anas Aljabo, CMC Sterilization Ltd Jenny Berg, Sterilucent Inc Trabue Bryans, BryKor LLC Tim Carlson, BD Medical Fiona Collins, American Dental Association Dania Cortes, Nelson Laboratories LLC Gary Cranston, Con
42、sulting if the biological indicator is intended for use in a moist heat process not using dry saturated steam, e.g. an air/steam mixture, the appropriate air steam mixture should be used and noted as an exception to this document, c) maximum exposure temperature: as stated by the manufacturer; if no
43、t stated by the manufacturer, a temperature of 140 C shall be used, and d) exposure time: greater than or equal to 30 min. NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a moist heat sterilization process. 8 I
44、noculated carriers and biological indicators The requirements of ISO 11138-1 apply. 9 Population and resistance 9.1 The manufacturer shall state the resistance characteristics in accordance with ISO 11138-1:2017, 6.4. 9.2 The viable count shall be stated with increments less than or equal to 0,1 10n
45、per unit (e.g. per ml of suspension, per inoculated carrier or per biological indicator). 9.3 For inoculated carriers and biological indicators, the viable count shall be greater than or equal to 1,0 105. 1These are examples of suitable products available commercially. This information is given for
46、the convenience of users of this document and does not constitute an endorsement by ISO of these products. 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-3:2017 3 9.4 The resistance shall be expressed as the D value in minutes at 121 C. Additional temperature(s)
47、may be selected by the manufacturer. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 121 C. 9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D12
48、1value of greater than or equal to 1,5 min when tested according to the conditions given in Annex A. Other microorganisms shall have D values supporting the application. The z value of the test organisms in the suspension, on the inoculated carrier or in the biological indicator shall be determined
49、at not less than three temperatures, in the range of 110 C to 138 C. These data shall be used to calculate the z value, which shall be greater than or equal to 6 C (see Annex B). 9.6 The resistance characteristics specified in this document and any other part of ISO 11138 shall be defined using the specific critical variables associated with the referenced sterilization process. 9.7 D values are determined according to methods given in ISO 11138-1:2017, Annexes C and D. 9.8 Determination of D value and survival-kill response characteristics requires the use
