ANSI TIR10993-20-2006 Biological evaluation of medical devices - Part 20 Principles and methods for immunotoxicology testing of medical devices.pdf

1、ANSI/AAMI/ISO TIR10993-20:2006Biological evaluation of medicaldevices Part 20: Principles andmethods for immunotoxicologytesting of medical devicesTechnicalInformationReportAssociation for the Advancementof Medical InstrumentationAn ANSI Technical Report prepared by AAMI ANSI/AAMI/ISO TIR10993-20:20

2、06 Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices Approved 5 September 2005 by Association for the Advancement of Medical Instrumentation Approved 16 October 2005 by American National Standards Institute, Inc. Abstract: Covers

3、 current state of knowledge in the area of immunotoxicology, including information on methods of assessment and their predictive value; to identify what the problems are and how they have been dealt with in the past; and offers advice on how the problems should be addressed in future standards. Keyw

4、ords: immunotoxicology, immunosuppression, immunostimulation, hypersensitivity, chronic inflammation, autoimmunity Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2006 by the Association for the Advancement of Medical Ins

5、trumentation 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 requests pertaining to this d

6、raft 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 Instrumentation. Violators risk lega

7、l 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 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States

8、 of America ISBN 1570202680 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a

9、TIR may need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards a

10、nd recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is n

11、ot subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted onreaffirmed, revised, or

12、withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the

13、 information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice, or because achieving consensus is extremely

14、 difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also

15、considered information that may be more recent than this document. All 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

16、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. Comments on this technical information report are invited and should b

17、e sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the ac

18、credited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of ANSI Technical Reports. This document is not an American National Standard and the material contained herein is not normative in nature. C

19、ontents Page Glossary of equivalent standards v Committee representation. vii Background of AAMI adoption of ISO/TS 10993-20. viii Foreword. x Introduction xii 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Risk assessment and risk management.2 5 Identification of hazards. 3 6 Met

20、hods of assessment of immunotoxicity . 5 6.1 General. 5 6.2 Inflammation 6 6.3 Immunosuppression. 6 6.4 Immunostimulation. 8 6.5 Hypersensitivity 8 6.6 Auto-immunity. 8 7 Extrapolation of data provided by pre-clinical assays 8 Annex A (informative) Current state of knowledge. 10 Annex B (informative

21、) Clinical experience with medical devices 14 Annex C (informative) Flow chart for immunotoxicity testing. 16 Bibliography . 17 2006 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR10993-20:2006 v Glossary of equivalent standards International Standards adopted in the Uni

22、ted 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. NOTEDocuments are sorted by interna

23、tional 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 technical va

24、riations IEC 60601-1-2:2001 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:

25、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/TR 60878:2003 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR

26、62296:2003 ANSI/AAMI/IEC TIR62296:2003 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 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 7199:1996 ANSI/AAMI/ISO 7199:1996

27、/(R)2002 Identical ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:200x2Identical 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

28、:1994 ANSI/AAMI/ISO 10993-6:1995/(R)2001 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 I

29、SO 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 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000 Identical

30、ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2003 Identical 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 TIR10993-19:2006 Identical vi 2006 Association for the Advancement of Medical In

31、strumentation ANSI/AAMI/ISO TIR10993-20:2006 International designation U.S. designation Equivalency ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135:1994 ANSI/AAMI/ISO 11135:1994 Identical ISO 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:2006 (2006-08-01 correc

32、ted version)ANSI/AAMI/ISO 11137-2:2006 Identical ISO 11137-3:2006ANSI/AAMI/ISO 11137-3:2006 Identical ISO 11138-1: 2006 ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 2006 ANSI/AAMI/ISO 11138-2:2006 Identical ISO 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 1

33、1138-4:2006 Identical ISO 11138-5: 2006 ANSI/AAMI/ISO 11138-5:2006 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-5:2000 ANSI/AAMI ST66:1999 Major technical variations ISO 11607-1:2006ANSI/AAMI/ISO 11607-1:2006 Identical

34、 ISO 11607-2:2006ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 11737-3:2004 ANSI/AAMI/ISO 11737-3:2004 Identical ISO 13485:2003 ANSI/AAMI/ISO 13485:2003 Identical ISO 13488:1996 ANSI/AAMI/ISO 1348

35、8:1996 Identical ISO 14155-1:2003 ANSI/AAMI/ISO 14155-1:2003 Identical ISO 14155-2:2003 ANSI/AAMI/ISO 14155-2:2003 Identical ISO 14160:1998 ANSI/AAMI/ISO 14160:1998 Identical ISO 14161:2000 ANSI/AAMI/ISO 14161:2000 Identical ISO 14937:2000 ANSI/AAMI/ISO 14937:2000 Identical ISO/TR 14969:2004 ANSI/AA

36、MI/ISO TIR14969:2004 Identical ISO 14971:2000 and A1:2003 ANSI/AAMI/ISO 14971:2000 and A1:2003 Identical ISO 15223:2000, A1:2002, and A2:2004 ANSI/AAMI/ISO 15223:2000, A1:2001, and A2:2004 Identical ISO 15225:2000 and A1:2004 ANSI/AAMI/ISO 15225:2000/(R)2006 and A1:2004/(R)2006 Identical ISO 15674:2

37、001 ANSI/AAMI/ISO 15674:2001 Identical ISO 15675:2001 ANSI/AAMI/ISO 15675:2001 Identical ISO/TS 15843:2000 ANSI/AAMI/ISO TIR15843:2000 Identical ISO 15882:2003 ANSI/AAMI/ISO 15882:2003 Identical ISO/TR 16142:2006 ANSI/AAMI/ISO TIR16142:2006 Identical ISO 17664:2004 ANSI/AAMI ST81:2004 Major technica

38、l variations ISO 17665-1:200x1ANSI/AAMI/ISO 17665-1:2006 Identical ISO 18472:2006 ANSI/AAMI/ISO 18472:2006 Identical ISO/TS 19218:2005 ANSI/AAMI/ISO 19218:2005 Identical ISO 25539-1:2003 and A1:2005 ANSI/AAMI/ISO 25539-1:2003 and A1:2005 Identical 1In production 2Final approval pending 2006 Associat

39、ion for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR10993-20:2006 vii Committee representation Association for the Advancement of Medical Instrumentation Biological Evaluation of Medical Devices Committee The adoption of ISO Technical Report (TR) 10993-20:2006 as an AAMI Technical In

40、formation Report was initiated by the AAMI Biological Evaluation Committee, which also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Systemic Toxicity Working Group (U.S. Sub-TAG for I

41、SO/TC 194/WG 7), chaired by Daniel McLain, PhD, CNS, DABFE, played an active part in developing the ISO Technical Report. Committee approval of this document does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Biological Eva

42、luation Committee had the following members: Cochairs: Donald E. Marlowe, FDA/CDRH Peter William Urbanski, Medtronic Inc. Members: James M. Anderson, MD, PhD, Case Western Reserve University (Independent Expert) Roger Dabbah, PhD, US Pharmacopeia Convention Inc. Lawrence H. Hecker, PhD, Hospira Inc.

43、 John G. Miller, DVM, Association for Assessment and Accreditation of Laboratory Animal Care International Barry F.J. Page (Independent Expert) Anita Y. Sawyer, Becton Dickinson and to offer advice on how the problems should be addressed in future standards. U.S. participation in this ISO/TC 194/WG

44、7 is organized through the U.S. Technical Advisory Group for ISO/TC 194, administered by the Association for the Advancement of Medical Instrumentation (AAMI) on behalf of the American National Standards Institute (ANSI). U.S. experts made a considerable contribution to this technical report. AAMI e

45、ncourages its committees to harmonize their work with international standards as much as possible. Upon review of ISO/TS 10993-20, the Biological Evaluation Committee and the AAMI Systemic Toxicity Working Group decided to adopt ISO/TS 10993-20:2006 verbatim as an AAMI Technical Information Report.

46、The intention of this edition of ISO/TS 10993-20 is to summarize the current state of knowledge in the area of immunotoxicology, including information on methods of assessment of immunotoxicity and their predictive value; and to identify what the problems are and how they have been dealt with in the

47、 past; AAMI (and ANSI) have adopted other ISO documents. 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 into this technical information

48、report should not be considered inflexible or static. This technical information report, 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 comes to

49、 light. Suggestions for improving this technical information report are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. NOTEBeginning with the ISO foreword on page x, this ANSI Technical Report/AAMI Technical Information Report is identical to ISO/TS 10993-20:2006. x 2006 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR10993-20:2006 Foreword ISO (the International Organization for