1、ANSI/AAMI/ISO 11140-1:2014Sterilization of health care productsChemical 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 recommend
2、ed 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 patient
3、 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 us
4、es 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 can
5、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 for
6、 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 in
7、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 crit
8、eria 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 used
9、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 pract
10、ice 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 personne
11、l 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 an A
12、AMI 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 authoriti
13、es). 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, w
14、hose 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, howev
15、er, 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 periodic
16、 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 it
17、s 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 observed
18、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 “unsa
19、fe“. 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 specific
20、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 co
21、njunction 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 Vice P
22、resident, 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 of
23、 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 been
24、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 11140-1:2014 (Revision of ANSI/AAMI/ISO 11140-1:2005) Sterilization of health care products Chemica
25、l indicatorsPart 1: General requirements Developed by Association for the Advancement of Medical Instrumentation Approved 10 September 2014 by American National Standards Institute, Inc. Abstract: Specifies performance requirements for indicators that show exposure to sterilization processes by mean
26、s of physical and/or chemical change of substances. Keywords: acceptance criteria, dry heat, ethylene oxide, performance requirements, radiation, steam AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned w
27、ith 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, or procedures not conforming to the standard. AAMI standards are subject t
28、o 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 withdraw this standard no later than five years from the date of publication. Int
29、erested 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 AAMI are voluntary, and their application is solely within the discretion and
30、 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 enforcement of its rules and regulations. Published by Association for the Ad
31、vancement of Medical Instrumentation 4301 N. Fairfax Dr., Ste. 301 Arlington, VA 22203-1633 www.aami.org 2015 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all o
32、r any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. 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 externa
33、lly) 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 at
34、 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-576-0 Contents Page Glossary of equivalent standards . iv Committee representation . v Background of AAMI adoption of ISO 11140-1:2014 . vii For
35、eword . viii Introduction ix 1 Scope . 1 2 Normative references . 1 3 Terms and definitions . 2 4 Categorization 4 5 General requirements 5 6 Performance requirements . 8 7 Test methods . 9 8 Additional requirements for process (Type 1) indicators 12 9 Additional requirements for single critical pro
36、cess variable (Type 3) indicators . 15 10 Additional requirements for multicritical process variable (Type 4) indicators 15 11 Additional requirements for steam integrating (Type 5) indicators . 16 12 Additional requirements for ethylene oxide integrating (Type 5) indicators 17 13 Additional require
37、ments for emulating (Type 6) indicators . 17 Annex A (normative) Method for demonstrating shelf-life of the product 19 Annex B (informative) Examples of testing indicators 20 Annex C (informative) Rationale for the requirements for integrating indicators and the link to the requirements for biologic
38、al indicators specified in ISO 11138 (all parts) and microbial inactivation . 21 Annex D (informative) Rationale for the liquid-phase test method for low temperature steam and formaldehyde indicators . 27 Annex E (informative) Relationship of indicator and indicator system components . 28 Bibliograp
39、hy . 29Glossary 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 ANSI). Available on the AAMI website at the
40、address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf iv 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 11140-1:2014 Committee representation Association for the Adv
41、ancement of Medical Instrumentation Chemical Indicators Working Group The adoption of ISO 11140-1:2014 as an American National Standard was initiated by the AAMI Chemical Indicators Working Group of the AAMI Sterilization Standards Committee. The AAMI Chemical Indicators Working Group also functions
42、 as a U.S. Technical Advisory Group to the relevant work in the International Organization for Sterilization (ISO). U.S. representatives from the AAMI Chemical Indicators Working Group (U.S. Sub-TAG for ISO/TC 198/WG 6, Chemical indicators) played an active part in developing the ISO standard. At th
43、e time this document was published, the AAMI Chemical Indicators Working Group had the following members: Chair: Richard Bancroft Kristen Singleton, PhD Members: Richard Bancroft, STERIS Corp. Robert Bradley, CBET, Mesa Laboratories Marc Chaunet, TSO3 Inc. Nancy Chobin, RN CSPDM, St. Barnabas Health
44、care System Charles Codgill, Covidien Kevin Corrigan, Advanced Sterilization Products Jacqueline Daley, Sinai Hospital of Baltimore Kimbrell Darnell, CR Bard Inc. Mary Ann Drosnock, MS Olympus America Inc. Marcia Ann Frieze, Case Medical, Inc. Gloria H. Frost, PhD DABT, Cardinal Health J.C. Fulghum,
45、 Hospira Joel R. Gorski, PhD, NAMSA Rachel Hill, Carefusion Charles Hughes, SPS Medical Supply Corp. Nupur Jain, Intuitive Surgical Inc. Geetha Jayan, Phd, FDA/CDRH Steven Kirckof, 3M Healthcare Susan Klacik, CCSMC FCS ACE, IAHCSMM Colleen Patricia Landers, RN, Landers Consulting CSA Stephen Loes, S
46、terilucent, Inc. Teckla Maresca, LPN CSPDM, St. Clares Health System Albert May, Anderson Products Inc. Patrick McCormick, PhD, Bausch the three prefixes that can be optionally added are listed in Table 1. The use of the term “indicator” versus the term “indicator system” has been redefined and clar
47、ified to make the terms more intuitive. There have been some changes to the performance requirements for type 1 indicators for steam, EO, and vaporized hydrogen peroxide processes, significant changes to the performance requirements for type 5 indicators for steam processes and EO processes, and del
48、etion of the requirements for type 5 indicators for dry heat processes. AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have adopted other ISO standards
49、. See the Glossary of Equivalent Standards for a list of ISO standards adopted by AAMI, which gives the corresponding U.S. designation and the level of equivalency with the ISO standard. The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological developments. To remain relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this standard are invited. Comments and suggest
