1、ANSI/AAMI/ISO 11138-1: 2017Sterilization of health care productsBiological indicatorsPart 1: General requirementsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recomm
2、ended 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 application of current technologies to pati
3、ent 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 provided that arbitrary and restrictive
4、 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 use, and the measurement techniques that c
5、an 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 performance characteristics, instructions
6、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 specialized test methods to facilitate uniformity
7、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 provided and the reasons for establishing the c
8、riteria 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 that will help ensure that a device is us
9、ed 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. Similarly, even though a recommended pr
10、actice 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, provide guidelines to industrial perso
11、nnel 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 industrial practices. In determining whether a
12、n 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 government regulatory or procurement author
13、ities). 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 professionals and industrial representatives
14、, 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 standard or recommended practice is limited, ho
15、wever, 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 responsible decision-making. Despite perio
16、dic 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 developed and the specific rationale for each of
17、 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 current procedures and practices. While observ
18、ed 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 serve to identify a particular product as “u
19、nsafe“. 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 be analyzed in the context of the specif
20、ic 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 is truly useful only when it is used in
21、 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 must be made in writing, to the AAMI Vic
22、e 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 of the Association only upon exhaustion
23、 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 or recommended practice which has not be
24、en 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 11138-1:2017 (Revision of ANSI/AAMI/ISO 11138-1:2006/(R)2015 Sterilization of health care produc
25、tsBiological indicatorsPart 1: General requirements Approved 14 April 2017 by AAMI Approved 1 August 2017 by American National Standards Institute Abstract: Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoc
26、ulated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. Keywords: carrier, primary pack, culture, D value, survivor, CFU, population, resistometer AAMI Standard This Association for the Advancement of Medical Instrumentat
27、ion (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 approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes,
28、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 withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdra
29、w 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 practices, technical information reports, and other types of technical documents developed by AAM
30、I 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 regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enf
31、orcement 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 Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this p
32、ublication 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 make copies of all or any
33、 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 permission regarding the use
34、 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) 276-0793. Printed in the United States of America ISBN 978-1-57020-678-8 Contents Page Glossary of eq
35、uivalent standards iv Committee representation . v Background of AAMI adoption of ISO 11138-1:2017 . vii Foreword viii Introduction . ix 1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4 General manufacturing requirements 4 5 Specific manufacturing requirements . 7 6 Determination of
36、population and resistance . 8 7 Culture conditions . 10 Annex A (normative) Determination of viable count 11 Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes . 13 Annex C (normative) D value determination by survivo
37、r curve method 15 Annex D (normative) D value determination by fraction negative method 19 Annex E (normative) Survival-kill response characteristics . 36 Annex F (informative) Relationship between components of biological indicators . 38 Bibliography . 40 iv 2017 Association for the Advancement of
38、Medical Instrumentation ANSI/AAMI/ISO 11138-1:2017 Glossary of equivalent standards International Standards adopted 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
39、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/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-1:2017 v Commi
40、ttee representation Association for the Advancement of Medical Instrumentation Biological Indicators Working Group The adoption of ISO 11138-1:2017 as an American National Standard was initiated by the AAMI Biological Indicators Working Group of the AAMI Sterilization Standards Committee. U.S. repre
41、sentatives 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 Working Group had the following members: Cochairs: Anthony Piotrkowski Craig Wallace Members: Anas Aljabo, CMC St
42、erilization 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, Consulting b) manufacturing (Clause 5);c) resistance characteristics (6.4);d) storage and transport (4.4);e) i
43、ncubation (7.3).NOTE 1 Advice on methods for the use of biological indicators is provided in ISO 14161. NOTE 2 National and/or regional requirements might exist, for example, in the various national or regional pharmacopoeias. 4.1.4 Personnel The procedures and methods in this document shall be carr
44、ied out by suitably trained and experienced laboratory personnel (see e.g. ISO 13485). 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-1:2017 5 4.2 Test organism 4.2.1 Strain 4.2.1.1 Test organisms shall be of a defined strain, available through a recognized cultu
45、re collection, and shall be identified by appropriate test methods. A statement of traceability shall be provided to the purchaser upon request. 4.2.1.2 The test organism shall be a strain that is a) suitable for handling without special containment facilities, does not need specific containment pro
46、cedures forhandling and does not have specific transport or mailing requirements (e.g. Risk Group 1, WHO 2004), andb) sufficiently stable to maintain its resistance characteristics for the duration of the stated shelf-life whentransported and stored in accordance with label directions.NOTE Tradition
47、ally, the test organisms of biological indicators have been bacterial spores, usually derived from Bacillus or Geobacillus species. 4.2.1.3 Test organisms other than bacterial spores may be used if they have been shown to provide appropriate resistance to the sterilization process. 4.2.2 Originating
48、 inoculum for suspension 4.2.2.1 The initial inoculum for each batch of test organism suspension shall be a) traceable to the reference culture and available through a recognized culture collection, andb) verified as to its identity and purity.4.2.2.2 The methods used for maintaining test organism c
49、ultures shall be designed to protect them from contamination and to minimize any induced changes in the inherent properties of the test organisms. 4.2.2.3 Verification tests are specific for each strain of test organism and shall be documented and validated. 4.2.3 Test organism count The viable test organism count of the suspension shall be determined in accordance with Annex A. 4.3 Information to be provided by the manufacturer (labelling) 4.3.1 The following information shall be provided on the label of each individual unit of suspension, inoculated carrier packaging a
