ANSI ST81-2004 Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices.pdf

1、ANSI/AAMI/ ST81:2004/ (R)2016Sterilization of medical devicesInformationto be provided by the manufacturer for theprocessing of resterilizable medical devicesAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potenti

2、al 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 effectiv

3、e 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 objective

4、s 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 clinic

5、al 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 the device, includi

6、ng 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 development of speci

7、alized 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 pr

8、ovided 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 practi

9、ces 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 for device evalua

10、tion. 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 device performance cri

11、teria, 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 in understanding i

12、ndustrial 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, they are adopted b

13、y 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 committee of health care

14、 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 patient safety. A st

15、andard 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 should never repla

16、ce 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 was initially dev

17、eloped 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 recommended practice to c

18、urrent 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 of information will

19、 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 recommended practice sh

20、ould 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 or recommended pra

21、ctice 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 pract

22、ices 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 official and represent

23、ation 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 explanation of a stan

24、dard 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 ST81:2004/(R)2016 Sterilization of medical devicesInfor

25、mation to be provided by the manufacturer for the processing of resterilizable medical devices Approved 2 December 2004 by Association for the Advancement of Medical Instrumentation Approved 13 December 2004 and reaffirmed 24 March 2010 and 23 May 2016 by American National Standards Institute, Inc.

26、Abstract: This standard specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor. Requirements are specified for the information to be provided by the m

27、edical device manufacturer so that the medical device can be processed safely and will continue to meet its performance specification. This standard also includes definitions, a bibliography, and informative annexes. Keywords: cleaning, disinfection, labeling, packaging, sterilizationAAMI Standard T

28、his 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, whether they have approved the standard or not, from manufactu

29、ring, 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 NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures r

30、equire that action be taken to reaffirm, 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 and recommended practices by calling or writing AAMI. All AAMI standards, recommended practices, t

31、echnical 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 the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies

32、 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 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2005 by the Association for the A

33、dvancement 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 form, including an electronic retrieval system, without the prior written permission of AAMI. All requ

34、ests pertaining to this document 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) without the prior written permission of the Association for the Advancement of Medical Instrume

35、ntation. 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, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-106

36、7. Printed in the United States of America ISBN 157020229X Contents Page Glossary of equivalent standards ivCommittee representation.viForeword.ixIntroduction x1 Scope12 Terms and definitions13 Information to be provided by the medical device manufacturer .23.1 Reprocessing instructions 23.2 Limitat

37、ions and restrictions on processing23.3 Preparation at the point of use prior to processing.23.4 Preparation before cleaning .33.5 Cleaning.33.6 Disinfection.33.7 Drying.43.8 Inspection, maintenance, and testing.43.9 Packaging 43.10 Sterilization.43.11 Storage 54 Presentation of the information .55

38、Validation of the reprocessing information provided56 Risk analysis .5Annexes A Commonly utilized reprocessing methods.6B An example of reprocessing instructions for reusable medical devices 9C Bibliography 12D Background of the development of ANSI/AAMI ST81 and rationale for national deviations to

39、EN ISO 17664.13 Tables A.1 Examples of processes that may be applied 7A.2 Blank table to define suitable reprocessing procedures .8Figures B.1 Template: Processing instructions (reusable medical devices) .9B.2 Example of processing instructions (reusable medical devices)11Glossary of equivalent stan

40、dards 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 (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the internation

41、al standard. (Note: Documents 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 6060

42、1-1-2:2001 and Amendment 1:2004 ANSI/AAMI/IEC 60601-1-2:2001 and Amendment 1:2004 Identical IEC 60601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:1990 and Amendment 1:1996 ANSI/AAMI II

43、51:2004 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 and Amendment 1:2000 (consolidated texts) Identical IEC 60601-2-24:1998 ANSI/AAMI ID26:2004 Major technical variations IEC TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC TR 62296:2003 ANSI/A

44、AMI/IEC TIR62296:2003 Identical ISO 5840:200x1ANSI/AAMI/ISO 5840:2005 IdenticalISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 IdenticalISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:1992 ANSI/AAMI/ISO 10993-2:1993/(R)2001

45、 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical ISO 10993-4:2002 ANSI/AAMI/ISO 10993-4:2002 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO

46、 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999 Identical ISO 10993-10:2002 ANSI/AAMI BE78:2002 Minor technical variations ISO 10993-11:1993 ANSI/AAMI 10993-11:1993 Minor technical variations ISO 10993-12:2002 ANSI/AAMI/ISO 10993-12:2002 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Ident

47、ical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000 Identical 1Currently at FDIS stage iv 2005 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST81:2004 International designation U.S. designation Equivalency ISO 10993-16:199

48、7 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO 11134:1994 ANSI/AAMI/ISO 11134:1993 Identical ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137:1995 and Amdt 1:2001 ANSI/AAMI/ISO 11137:1994 and A1:2002 Identical ISO 11138-1:1994 A

49、NSI/AAMI ST59:1999 Major technical variations ISO 11138-2:1994 ANSI/AAMI ST21:1999 Major technical variations ISO 11138-3:1995 ANSI/AAMI ST19:1999 Major technical variations ISO TS 11139:2001 ANSI/AAMI/ISO 11139:2002 Identical ISO 11140-1:1995 and Technical Corrigendum 1:1998 ANSI/AAMI ST60:1996 Major technical variations ISO 11607:2003ANSI/AAMI/ISO 11607:2000 Identical ISO 11737-1:1995 ANSI/AAMI/ISO 11737-1:1995 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 11737-3:2004 ANSI/AAMI/ISO 11737-3:2004 Identical ISO TR 13409:1996 AAMI/ISO TIR13409:1996 Identica