1、ANSI/AAMI/ISO 11138-2: 2017Sterilization of health care productsBiological indicatorsPart 2: Biological indicators for ethylene oxide sterilization processesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potentia
2、l 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 in the safe and effective
3、 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 attention to these objectives
4、 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 qualifying the device for clinica
5、l 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 with the device, includin
6、g 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 the development of specia
7、lized 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 pro
8、vided 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 practic
9、es 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 reference for device evaluat
10、ion. 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 crit
11、eria, 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 in
12、dustrial 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
13、 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 committee of health care
14、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 ensure patient safety. A sta
15、ndard 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 replac
16、e 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 document was initially deve
17、loped 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 cu
18、rrent 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
19、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 recommended practice sho
20、uld 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 prac
21、tice 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 practi
22、ces 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 representa
23、tion 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 stand
24、ard 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 11138-2:2017 (Revision of ANSI/AAMI/ISO 11138-2:2006
25、/(R)2015 Sterilization of health care productsBiological indicatorsPart 2: Biological indicators for ethylene oxide sterilization processes Approved 14 April 2017 by AAMI Approved 1 August 2017 by American National Standards Institute Abstract: Specifies requirements for test organisms, suspensions,
26、 inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing te
27、mperatures within the range of 29 C to 65 C. Keywords: carrier, packaging, organism, 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 s
28、tandard 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 periodic review, and users are cautioned to obtain the
29、 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. Interested parties may obtain current information on all AA
30、MI 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 professional judgment of the user of the document. Occa
31、sionally, 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 AAMI 4301 N. Fairfax Dr., Suite. 301 Arlington, VA 22203-1633 www.aami.org 201
32、7 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 publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permi
33、ssion 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 part of this document (whether internally or externally) without the prior written permission of the Association for the Advancem
34、ent 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, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Su
35、ite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 978-1-57020-679-5 Contents Page Glossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 11138-2:2017 . vii Foreword viii Introductio
36、n . ix 1 Scope . 1 2 Normative references . 1 3 Terms and definitions . 1 4 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 re
37、sistance to ethylene oxide sterilization . 4 Annex B (informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 30 C . 5 Bibliography . 6 iv 2017 Assoc
38、iation for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-2:2017 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
39、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/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI
40、/AAMI/ISO 11138-2:2017 v Committee representation Association for the Advancement of Medical Instrumentation Biological Indicators Working Group The adoption of ISO 11138-2:2017 as an American National Standard was initiated by the AAMI Biological Indicators Working Group of the AAMI Sterilization S
41、tandards 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 Working Group had the following members: Cochairs: Anthony Piotrkowski Craig Wallac
42、e 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, Consulting survival time greater than or equal to 10 min and kill time less than
43、 or equal to 25 min; at 54 C, 2,0 D value; survival time greater than or equal to 8 min and kill time less than or equal to 20 min. 4 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-2:2017 Annex A (normative) Method for determination of resistance to ethylene oxid
44、e sterilization A.1 PrincipleThis method requires the use of a test apparatus referred to as a resistometer in this document. The specifications of the resistometer process parameters for ethylene oxide sterilization processes are provided in ISO 18472. Specific requirements related to the test meth
45、od are provided in A.2. A.2 ProcedureA.2.1 Load the samples on to suitable sample holders.A.2.2 Preheat the resistometer chamber to the test condition of 54 C.A.2.3 Place the loaded sample holders in the chamber, close the chamber and initiate the test cycle.A.2.4 Carry out the following sequence of
46、 operations: Step 1: Evacuate the chamber to a vacuum set point of 10 kPa 0,5 kPa. Step 2: Admit sufficient water vapour to raise the relative humidity in the chamber to 60 % 10 %. Maintain these conditions for a period of 30 min 1 min. The samples should be allowed to warm to above the dew point pr
47、ior to injection of water vapour to avoid the potential for condensation. Step 3: Admit ethylene oxide gas to the chamber to obtain a concentration of 600 mg/l 30 mg/l within 60 s. For the 0 min exposure time, no ethylene oxide gas shall be admitted. Step 4: Maintain these conditions for the require
48、d exposure time 5 s. Step 5: At the end of the exposure time, evacuate the chamber to 10 kPa or less within 60 s and then admit filtered air, or an inert gas (such as nitrogen) to ambient pressure. Step 6: Repeat step 5 four additional times or more if necessary to reduce operator exposure to any st
49、erilant remaining in the chamber. Step 7: At the end of the above test cycle, remove the samples from the chamber and transfer the samples to the growth medium and incubate (see ISO 11138-1:2017, Clause 7). A.2.5 The transfer period shall be documented and the same time period shall be used for all tests.A.3 Determination of resistanceResistance characteristics shall be determined according to methods given in ISO 11138-1:2017, Annexes C, D and E. 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11138-2:2017 5
