1、Association for the Advancementof Medical InstrumentationANSI/AAMI/ISO 14161:2009Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsObjectives and uses of AAMI standards and recommended practices It is most important that the obje
2、ctives 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 in the
3、 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 attention
4、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 qualifying the
5、 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 with t
6、he 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 the de
7、velopment 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, refere
8、e 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 rather pro
9、cedures 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 reference
10、 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 devi
11、ce 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 professionals
12、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 course,
13、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 commit
14、tee 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 ensure pa
15、tient 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, but it
16、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 document
17、 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 recomme
18、nded 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 source o
19、f 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 recom
20、mended 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 standard
21、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 standards and
22、 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 offi
23、cial 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 or exp
24、lanation 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 14161:2009 (Revision of ANSI/AAMI
25、/ISO 14161:2000) Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results Approved 3 September 2009 by Association for the Advancement of Medical Instrumentation Approved 30 September 2009 by American National Standards Institute, Inc.
26、 Abstract: This American National Standard provides guidance for the selection, use, and interpretation of results from the application of biological indicators in the development, validation, and routine monitoring of sterilization processes Keywords: bioburden, D value, incubation, inoculated carr
27、ier, PCD, SAL, survival/kill window, sterilization process validation 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 re
28、spect 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 latest editions. CAUTION
29、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 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or wr
30、iting AAMI or by visiting the AAMI website at www.aami.org. 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
31、 the document. Occasionally, 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 Association for the Advancement of Medical Instrumentation
32、1110 N. Glebe Rd., Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any fo
33、rm, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this draft 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
34、) 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 of all or any part of this document, contact AAMI, 1110
35、 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 157020368-7Contents Page Glossary of equivalent standards .v Committee representation vii Background of ANSI/AAMI adoption of ISO 14161:2009 .x Forewordxi Int
36、roduction xii 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 General.6 5 Characteristics of biological indicators7 5.1 General.7 5.2 Test organism suspension for direct inoculation of products 8 5.3 Inoculated carriers9 5.4 Self-contained biological indicators .9 5.5 Other biological
37、 indicators 10 6 Selection of supplier.10 6.1 General.10 6.2 Documentation 11 7 Biological indicators in process development 12 7.1 General.12 7.2 Overkill approach13 7.3 Combined biological indicator and bioburden method 14 7.4 Bioburden method 15 8 Biological indicators in sterilization validation
38、 .15 8.1 General.15 8.2 Placement and handling of biological indicators15 8.3 Sterilizer qualification.16 8.4 Performance qualification16 8.5 Review and approval of validation16 8.6 Requalification 16 9 Biological indicators in routine monitoring .17 9.1 General.17 9.2 Placement and handling of biol
39、ogical indicators17 9.3 Process challenge device (PCD) .18 10 Results .18 10.1 General.18 10.2 Interpretation of results18 11 Application of biological indicator standards19 11.1 General assessment of biological indicator performance by the user .19 11.2 Nominal population of test organism .19 11.3
40、Resistance determination 20 11.4 z value determination22 11.5 F(T, z)equivalent sterilization value determination.25 11.6 Establishing spore-log-reduction (SLR).25 11.7 Sterility assurance level (SAL) calculation 26 11.8 Test equipment26 12 Culture conditions 26 12.1 General.26 12.2 Incubation tempe
41、rature 27 12.3 Incubation period27 12.4 Choice of growth medium27 13 Third-party requirements .28 13.1 General.28 13.2 Minimum requirements for replicates and total number of biological indicators29 13.3 Test equipment29 14 Personnel training.30 15 Storage and handling .30 16 Disposal of biological
42、indicators.30 Annex A (informative) Microbiological inactivation kinetics and enumeration techniques .32 Annex B (informative) Process challenge devices .38 Annex C (informative) Formulae for fraction negative methods for D value calculations40 Annex D (informative) Examples of documentation for bio
43、logical indicators prepared by the user.56 Annex E (informative) Calculation of z value .61 Annex F (informative) D value determination by survivor curve method.64 Annex G (informative) Survival-kill response characteristics .68 Bibliography .69 Glossary of equivalent standards International Standar
44、ds adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Document
45、s are sorted by international designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:
46、2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2009 ANSI/AAMI/IEC 60601-2-2:2009 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:2009 ANSI/AAMI/IEC 60601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/A
47、AMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004/(R)2009 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC
48、80601-2-30:2009 ANSI/AAMI/IEC 80601-2-30:2009 Identical (with inclusion) IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 62296:2009 ANSI/AAMI/IEC TIR62296:2009 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/T
49、R 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:2009 ANSI/AAMI/ISO 7199:2009 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003/(R)2009 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002/(R)2009 and Amendme
