1、ANSI/AAMI/ISO 11138-5: 2017Sterilization of health care productsBiological indicatorsPart 5: Biological indicators for low-temperature steam and formaldehyde sterilization processesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the
2、 objectives and potential uses 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 i
3、n the safe and effective application 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 atten
4、tion to these objectives and 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 qualifyin
5、g the device for clinical use, 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 w
6、ith the device, including performance 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 t
7、he development of specialized 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, r
8、eferee tests must be provided 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 rathe
9、r procedures and practices that 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 refe
10、rence for device evaluation. 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
11、 device performance criteria, 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 professio
12、nals in understanding industrial 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 cou
13、rse, they are adopted by government 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 c
14、ommittee of health care professionals 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 ensu
15、re patient safety. A standard 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, bu
16、t it should never replace responsible 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 doc
17、ument was initially developed 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 re
18、commended practice to current 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 sou
19、rce of information will serve 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
20、recommended practice should 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 stan
21、dard or recommended practice 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 standard
22、s and recommended practices 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
23、 official and representation 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 o
24、r explanation of a standard 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 11138-5:2017 (Revision of AN
25、SI/AAMI/ISO 11138-5:2006/(R)2015 Sterilization of health care productsBiological indicatorsPart 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Approved 14 April 2017 by AAMI Approved 1 August 2017 by American National Standards Institute Abstract: Specifi
26、es requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. Keywords: carrier, exposure, inoculated, li
27、quid-phase, organism, suspension, resistance 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, wh
28、ether 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 periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standar
29、d 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. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI s
30、tandards, 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 professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted
31、 by government regulatory 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
32、 Instrumentation All 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 docu
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34、l 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, 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
35、-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 978-1-57020-682-5 Contents PageGlossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 11138-5:2017 . vii Foreword viii Introduction . ix 1 Scope 1 1 Normative references 1 2 Terms an
36、d definitions . 1 3 General requirements . 1 4 Test organism 2 5 Suspension 2 6 Carrier and primary packaging 2 7 Inoculated carriers and biological indicators . 2 8 Population and resistance 2 Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde . 4 A
37、nnex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators 6 Bibliography . 7 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-5:2017 Glossary of equivalent standards International Standards a
38、dopted in the United States may include normative references to other International 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
39、 and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-5:2017 v Committee representation Association for the Advancement of Medical Instrumentation Biological Indicators Working
40、Group The adoption of ISO 11138-5:2017 as an American National Standard was initiated 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 stan
41、dard. At the time this document was published, the AAMI Biological Indicators Working 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,
42、American Dental Association Dania Cortes, Nelson Laboratories LLC Gary Cranston, Consulting b) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, the maximumexposure temperature shall be greater than or equal to 100 C;c) exposure time: greater than or equ
43、al to 160 min.NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a low-temperature steam and formaldehyde sterilization process. 7 Inoculated carriers and biological indicators The requirements of ISO 11138-1 appl
44、y. 8 Population and resistance 9.1 The resistance characteristics shall be stated according to ISO 11138-1:2017, 6.4. 9.2 The viable count shall be stated with increments less than or equal to 0,1 10nper unit (e.g. per ml of suspension, per inoculated carrier or per biological indicator). 1These are
45、 examples of suitable products available commercially. This information is given for 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 11138-5:2017 3 9.3 For inocula
46、ted carriers and biological indicators, the viable count shall be greater than or equal to 1,0 105. 9.4 The resistance shall be expressed as the D value in mins at 60 C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 6
47、0 C. 9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D60value of greater than or equal to 6 min when tested according to the conditions in Annex A. Other microorganisms shall have D values supporting the application. 9.6 The
48、 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 Determi
49、nation of D value and survival-kill response characteristics are based on the process parameters in Annex A. 9.9 The survival-kill window should be calculated using the formulae in ISO 11138-1:2017, Annex E. NOTE This information can be of value to the user when comparing different batches from the same manufacturer. EXAMPLE Using the formulae in ISO 11138-1:2017, Annex E, with the minimum population and minimum D value requirements specified in this document, the survival-kill response characteristics are at 60 C: survival time greater than or equal to 18 min
