ANSI ST67-2011 Sterilization of health care products-Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile (FDA RECOGNIZED).pdf

1、Association for the Advancementof Medical InstrumentationANSI/AAMI ST67:2011Sterilization of health care productsRequirements and guidance for selecting a sterilityassurance level (SAL) for products labeled “sterile”Objectives and uses of AAMI standards and recommended practices It is most important

2、 that the 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 i

3、ncrease in 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 w

4、ith attention 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

5、qualifying the 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 p

6、rovided with the 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 neces

7、sitates the 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 cr

8、iteria, referee 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,

9、but rather 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 fram

10、e of reference 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 a

11、ddressing device 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

12、professionals 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 (unles

13、s, of course, 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 experti

14、se of a committee 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

15、help ensure patient 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-m

16、aking, but it 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 wh

17、y the document 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 appl

18、ying a recommended 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 s

19、ingle source of 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. Simi

20、larly, a recommended 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 summar

21、y, a standard 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

22、 standards and 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 wi

23、ll become official 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 character

24、ization or 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 ST67:2011 (Revision of

25、ANSI/AAMI ST67:2003/(R)2008) Sterilization of health care products Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile” Developed by Association for the Advancement of Medical Instrumentation Approved 11 April 2011 by American National Standards In

26、stitute, Inc. Abstract: This standard establishes requirements and guidance for selection of an appropriate sterility assurance level for terminally sterilized health care products. Keywords: sterility assurance level (SAL), terminal sterilization AAMI Standard This Association for the Advancement o

27、f 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, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using

28、 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 NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffi

29、rm, revise, or withdraw this standard no later than five years from the date of publication. Interested 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 docu

30、ments developed by AAMI are voluntary, and their application is solely within the discretion and 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

31、is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2011 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publica

32、tion, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or 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

33、. 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 Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 p

34、er 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 Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 15

35、70204160 Contents Page Glossary of equivalent standards iv Committee representation . vi Foreword . ix Introduction x 1 Scope 1 1.1 Inclusions . 1 1.2 Exclusions 1 2 Normative references . 1 3 Definitions . 1 4 Determination of an appropriate SAL for a health care product to be labeled “STERILE” 2 4

36、.1 General 2 4.2 Selection of an SAL for a terminal sterilization process . 2 4.2.1 General 2 4.2.2 Selection based on intended use of the health care product . 3 4.2.3 Selection based on sterilization process and/or validation method . 3 4.2.4 Selection based upon the products inability to withstan

37、d a terminal sterilization process that achieves a 10-6SAL . 3 Annexes A Background and historical application of sterility assurance 5 B Examples of terminally sterilized products and sterility assurance levels that have historically been selected 6 C Guidance on Performing a Risk Analysis for Sele

38、cting an SAL for a product that cannot be sterilized to a 10-6SAL . 7 D Bibliography 9 Table B.1 Examples of historical sterility assurance levels for terminally sterilized products* 6 Figure 1 Decision tree for selection of SAL for medical devices to be terminally sterilized (section 4.2) . 4 iv 20

39、11 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST67:2011 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (an

40、d ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/I

41、SO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. Inter

42、national designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005 and ANSI/AAMI ES60601-1:2005/A2:2010 ANSI/AAMI ES60601-1:2005/C1:2009 (amdt) Major technical variations C1 Identical to Corrigendum 1 “should” indicates that among several possib

43、ilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited; “may” is used t

44、o indicate that a course of action is permissible within the limits of the standard; and “can” is used as a statement of possibility and capability. “Must” is used only to describe “unavoidable” situations, including those mandated by government regulation. AAMI and ANSI procedures require that stan

45、dards be reviewed every five years and, if necessary, revised to reflect technological advances that may have occurred since publication. The concepts incorporated in this standard should be c onsidered flexible and dy namic. AAMI policies and procedures require that AAMI standards and recommended p

46、ractices be reviewed and, if necessary, revised at least once every five years. To remain relevant, it must be modified as technological advances are made and as new data comes to light. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Technical

47、 Programs, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. NOTE This foreword does not contain provisions of the AAMI standard Sterilization of medical devicesRequirements for products labeled “sterile” (ANSI/AAMI ST67:2011), but it does provide important information about the deve

48、lopment and intended use of the document. x 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST67:2011 Introduction A sterile medical device is one that is free of viable microorganisms. Sterility of a medical device can be achieved through: a) a terminal sterilization proce

49、ss; b) sterilization of components, followed by sterile filtration of the final liquid formulation and aseptic filling into sterilized containers; or c) a combination of chemical/physical sterilization and aseptic processing. Products produced in accordance with manufacturing quality system requirements for medical devices typically have microorganisms on them before sterilization. Such products are nonsterile. The purpose of sterilization processing is to inactivate the microbiological contaminants and thereby transform the nonsterile products into sterile products. The