ANSI AAMI 11138-5-2017 Sterilization of health care products-Biological indicators-Part 5 Biological indicators for low-temperature steam and formaldehyde sterilization processes.pdf

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

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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

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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

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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

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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

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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