ANSI AAMI 22442-3-2007 Medical devices utilizing animal tissues and their derivatives - Part 3 Validation of the elimination and or inactivation of viruses and transmissible spongi.pdf

1、ANSI/AAMI/ISO 22442-3:2007/(R)2016Medical devices utilizing animal tissues and theirderivativesPart 3: Validation of the eliminationand/or inactivation of viruses and transmissiblespongiform encephalopathy (TSE) agentsAmerican National StandardObjectives and uses of AAMI standards and recommended pr

2、actices It is most important 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 advan

3、cement are (1) a continued increase 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, prov

4、ided that they are drafted with 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 t

5、hat should be considered in 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

6、information that should be provided 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

7、 characteristics often necessitates 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 minim

8、um safety and performance criteria, 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

9、 device performance per se, 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

10、user of the device as a frame 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 recomm

11、ended practices, while not addressing 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 m

12、ay be useful to health care 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 pr

13、actices are voluntary (unless, 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 ref

14、lects the collective expertise 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 clinica

15、l needs and, ultimately, to 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 referen

16、ce in responsible decision-making, 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 car

17、efully review the reasons why 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 device

18、s and equipment, and in applying 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

19、 to existing equipment. No single 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-

20、benefit considerations. Similarly, 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 underly

21、ing its provision. In summary, 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

22、 for interpretations of AAMI 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

23、Board. The interpretation will 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 resp

24、onsibility for any characterization 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/

25、AAMI/ISO 22442-3:2007/(R)2016 Medical devices utilizing animal tissues and their derivativesPart 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents Approved 24 January 2008 by Association for the Advancement of Medical Instrumenta

26、tion Approved 25 January 2008 and reaffirmed 22 November 2016 by American National Standards Institute Inc. Abstract: Specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in-vitro diagnostic me

27、dical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. Does not cover other transmissible and non-transmissible agents. Keywords: viruses, transmissible agents, TSE AAMI Standard This Association for the Advancement of Me

28、dical 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 pro

29、ducts, 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 reaffirm,

30、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 document

31、s 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 is r

32、esponsible 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 2007 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publica

33、tion is subject to copyright claims of ISO 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 requests pertaining to this draft should be submitted to AAMI. It is illegal unde

34、r 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 Instrumentation. Violators risk legal action, including civil and criminal penalties, an

35、d damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 301 N. Fairfax Drive Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-308-3 Contents PageGlossar

36、y of equivalent standards . iv Committee representation vi Background of AAMI Adoption of ISO 22442-3:2007 . vii Foreword iv Introduction x 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 3 4.1 Risk management . 3 4.2 Sourcing and manufacturing process 3 4.3 G

37、eneral requirements related to validation 3 5 Literature review . 4 5.1 Conduct of the literature review 4 5.2 Application of literature review output . 4 5.3 Viruses . 4 5.4 TSE agents. 5 6 Elimination and/or inactivation study of viruses and TSE agents. 5 6.1 General. 5 6.2 Protocol 5 6.3 Conduct

38、of the study 6 6.4 Interpretation of data 6 7 Final report 6 8 Review of final report 7 9 Routine monitoring and control of critical process parameters 7 Annex A (normative) Requirements related to literature review . 8 Annex B (informative) Guidance on the elimination and/or inactivation study for

39、viruses 12 Annex C (informative) Guidance on the elimination and/or inactivation study for TSE agents. 17 Annex D (informative) Guidance on scaling down 19 Annex E (informative) Statistical evaluation of virus titres and reduction factors and assessment of their validity 20 Annex F (informative) Cal

40、culation of reduction factors . 21 Annex G (informative) Probability of detection of agents at low concentrations 22 Bibliography . 23 iv 2007 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 22442-3:2007 Glossary of equivalent standards International Standards adopted in the

41、 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: Documents are sorted by i

42、nternational 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 ES60601-1:2005 Major techni

43、cal variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 IdenticalIEC 60601-2-2:2006 ANSI/AAMI/IEC 60601-2-2:2006 IdenticalIEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:1990 and Amendment 1:1996 ANSI/AAMI II36:2004 Major technical variations IEC 60601-2-20:19

44、90 and Amendment 1:1996 ANSI/AAMI II51:2004 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 60601-2-47:2001 ANSI/AAMI EC38:2007 Majo

45、r technical variations IEC 60601-2-50:2001 ANSI/AAMI/IEC 60601-2-50:2006 Identical IEC/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 IdenticalIEC/TR 62296:2003 ANSI/AAMI/IEC TIR62296:2003 IdenticalIEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 IdenticalISO

46、 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R)2002 IdenticalISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003

47、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 Identical ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002 and Amendment 1:2006 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 1

48、0993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:1995 ANSI/AAMI/ISO 10993-7:1995/(R)2001 Identical ISO 10993-9:1999 ANSI/AAMI/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002 ANSI/AAMI BE78:2002/A1:2006 Minor technical variations Identical ISO

49、 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007 Identical ISO 10993-13:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical International designation U.S. designation Equivalency ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002 Identical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-1