ANSI TIR15499-2017 Biological evaluation of medical devices-Guidance on the conduct of biological evaluation within a risk management process.pdf

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1、AAMI/ISO TIR15499: 2017 Technical Information ReportBiological evaluation of medical devicesGuidance on the conduct of biological evaluation within a risk management processAAMI Technical Information Report AAMI/ISO TIR15499:2017 Biological evaluation of medical devicesGuidance on the conduct of bio

2、logical evaluation within a risk management process Approved 11 June 2017 by AAMI Registered 27 August 2017 with American National Standards Institute Abstract: Provide guidance applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1 and is

3、applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. Keywords: biological evaluation, risk management, risk assessment, biological testing, material characterization, chemical characterization, biologic

4、al safety assessment Published by AAMI 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of al

5、l 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. 101, et seq.) to make copies of all or any part of this document (whether internally or exte

6、rnally) 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, complete the

7、 reprint request form at www.aami.org or contact AAMI at 4301 N. Fairfax Drive, Suite 310, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 978-1-57020-686-3 AAMI Technical Information Report A technical information report (TIR) is a

8、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 TIR may need further evaluation by experts, releasing the information is valuable because the industry a

9、nd 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 and recommended practices are subject to a formal process of committee approval, public review, and resol

10、ution 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 not subject to the same formal approval process as a standard. However, a TIR is approved for distributio

11、n 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 withdrawnand the action formally approved usually every five years but at least every 10 years. For a TI

12、R, 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 information is relevant or of historical value. If the information is not useful, the TIR is removed fr

13、om 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 difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on techni

14、cal 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 considered information that may be more recent than this document. All standards, recommended practices,

15、 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 of the document. Occasionally, voluntary technical documents are adopted by government regulatory agenci

16、es 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 be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633.

17、ANSI Registration Publication of this Technical Report that has been registered with ANSI has been approved by the Accredited Standards Developer (AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633). This document is registered as a Technical Report according to the Procedures for the

18、Registration of Technical Reports with ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite

19、 301, Arlington, VA 22203-1633. Contents Page Glossary of equivalent standards . v Committee representation . vi Background of AAMI adoption of ISO/TR 15499:2016 . viii Foreword . ix Introduction x 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Biological evaluation as a risk managem

20、ent practice 2 4.1 General 2 4.2 The biological evaluation plan 3 Figure 1Schematic representation of the risk management process (from ISO 14971) . 4 5 Guidance on risk management . 5 5.1 Risk assessment 5 5.1.1 Introduction 5 5.1.2 Risk analysis 5 5.1.3 Risk estimation 6 5.1.4 Risk evaluation 6 5.

21、1.5 Risk control 6 5.2 Evaluation of residual risk acceptability 7 5.3 Post production monitoring 7 6 Guidance on specific aspects of biological evaluation 7 6.1 Material characterization 7 6.1.1 Chemical characterization 7 6.1.2 Use of chemical characterization data in a biological evaluation . 7 6

22、.1.3 Proprietary materials formulations . 8 6.1.4 Effects of manufacturing processes . 8 6.2 Biological evaluation 8 6.2.1 Determining the acceptability of the level of leachable (allowable limit) according to ISO 10993-17 . 8 6.2.2 pH and osmolality compensation for absorbable materials 8 6.3 Devic

23、e testing considerations 9 6.3.1 Tiered approaches to biological testing 9 6.3.2 When to do long-term testing (chronic toxicity, reproductive toxicity, biodegradation and carcinogenicity studies) 9 6.4 Biological safety assessment . 10 6.4.1 Thresholds of Toxicological Concern (TTC) . 10 6.4.2 What

24、constitutes sufficient justification and/or clinically relevant data for a risk assessment 10 6.4.3 Guidance on mixtures in risk assessment 10 6.4.4 What constitutes “sufficient toxicology data” including dose and route relevance 10 6.4.5 What to include in the biological safety assessment report 10

25、 6.5 General guidance . 11 6.5.1 Changes which can require re-evaluation of biological safety . 11 6.5.2 Good laboratory practice 12 Bibliography . 13 2017 Association for the Advancement of Medical Instrumentation AAMI/ISO TIR15499:2017 v Glossary of equivalent standards International Standards ado

26、pted 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 International Standard. NOTE: Documents are

27、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/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other normat

28、ively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. www.aami.org/standards/glossary.pdf vi 2017 Association for the Advancement of Medical Instrumentation AAMI/ISO TIR15499:2017 Committee representat

29、ion Association for the Advancement of Medical Instrumentation Strategic Approach to Biological Assessment Working Group The adoption of ISO TR 15499 as an AAMI Technical Information Report was initiated by the AAMI Strategic Approach to Biological Assessment Working Group (BE/WG 15). AAMI BE/WG 15

30、functions as the U.S. consensus body to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from AAMI BE/WG 15 played a very active part in developing the ISO Technical Report. At the time this document was published, the AAMI Strategic Approach to Bio

31、logical Assessment Working Group had the following members: Cochair: Jon Cammack, PhD, DABT Members: Carolyn Braithwaite-Nelson, Spectranetics Corporation David Brodersen, LexaMed Ltd Ronald Brown, FDA/CDRH Taylor Builee, Edwards Lifesciences Jon Cammack, PhD, DABT, Nevakar LLC Julia Cesur-Levinsky,

32、 Medline Industries Inc Gloria Frost, PhD, DABT, Cardinal Health Jill Glosson, Baxter Healthcare Corporation Joel Gorski, PhD, NAMSA Niranjan Goud, PhD, Cook Inc Mike Groendyk, Arthrex Inc John Iannone, BME, John Iannone LLC Todd Kennedy, PhD, WL Gore and substantiation of risk evaluation, risk cont

33、rol, and compensation/adjustment of pH and osmolality. U.S. participation in ISO/TC 194 is organized through the U.S. Technical Advisory Group to ISO/TC 194, administered by the Association for the Advancement of Medical Instrumentation. Experts from the United States made a considerable contributio

34、n to this standard. AAMI/ISO TIR 15499 was registered with the American National Standards Institute (ANSI) on 27 August 2017. AAMI procedures recommend that technical information reports be reviewed every three years and, if necessary, revised to reflect technological advances that may have occurre

35、d since publication. AAMI (and ANSI) have adopted other ISO standards and technical reports. 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. As used within the con

36、text of this document, “shall” indicates requirements strictly to be followed to conform to the recommended practice. “Should” indicates that among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is prefer

37、red 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 to indicate that a course of action is permissible within the limits of the recommended practice. “Can” is used as a statement of possibil

38、ity and capability. Finally, “must” is used only to describe “unavoidable” situations, including those mandated by government regulation. NOTE Users of this technical information report are advised that this document is an AAMI identical adoption of an ISO document and that the following internation

39、al conventions have been carried over to the AAMI publication: British English spelling (e.g. colour instead of color) Use of SI units (e.g. metres instead of feet, Celsius instead of Fahrenheit, etc.) Decimal comma instead of a decimal point (e.g. 1 000,15 instead of 1,000.15) The concepts incorpor

40、ated in this technical information 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 advance

41、s are made and as new data come to light. Suggestions for improving this technical information report are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Dr, Suite 301, Arlington, VA 22203-1633. 2017 Association for the Advancement of Medical I

42、nstrumentation AAMI/ISO TIR15499:2017 ix Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member b

43、ody interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electro

44、technical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of

45、ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held

46、responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information

47、given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers

48、to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html. The committee responsible for this document is ISO/TC 194, Biological and clinical evaluation of medical devices. This second edition cancels and replaces the first edition (ISO/TR 15499:2012), which has been technically revised wi

49、th the following major changes: definitions have been clarified; risk evaluation and risk control have been substantiated; compensation/adjustment of pH and osmolality has been substantiated. x 2017 Association for the Advancement of Medical Instrumentation AAMI/ISO TIR15499:2017 Introduction General This document provides guidance on the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. Although ISO 10993-1 provides a general framework for biological evaluation of medical devices, more detailed guidance can