ANSI AAMI 11138-2-2017 Sterilization of health care products-Biological indicators-Part 2 Biological indicators for ethylene oxide sterilization processes.pdf

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

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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

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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

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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

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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

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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