ANSI AAMI 22442-1-2016 Medical devices utilizing animal tissues and their derivatives-Part 1 Application of risk management.pdf

1、ANSI/AAMI/ISO 22442-1: 2016Medical devices utilizing animal tissues and their derivativesPart 1: Application of risk managementAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product stan

2、dard 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 effective application of current techno

3、logies 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 objectives and provided that arbitrary a

4、nd 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 clinical use, and the measurement tec

5、hniques 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, including performance characteristics,

6、 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 specialized test methods to facilita

7、te 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 provided and the reasons for esta

8、blishing 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 practices that will help ensure that

9、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 evaluation. Similarly, even though a

10、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 criteria, provide guidelines to in

11、dustrial 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 industrial practices. In determi

12、ning 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 by government regulatory or proc

13、urement 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 professionals and industrial r

14、epresentatives, 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 standard or recommended practice

15、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 replace responsible decision-making.

16、 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 developed and the specific rationa

17、le 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 current procedures and practices

18、. 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 serve to identify a particular

19、 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 should be analyzed in the context

20、 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 practice is truly useful only when

21、 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 practices must be made in writing, t

22、o 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 representation of the Association only u

23、pon 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 standard or recommended practice wh

24、ich 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/ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivativesPart 1:

25、 Application of risk management Approved 29 April 2016 by AAMI Approved 17 November 2016 by American National Standards Institute Abstract: Applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been r

26、endered non-viable. Specifies, in conjunction with ANSI/AAMI/ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Outlines the deci

27、sion process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ANSI/AAMI/ISO 14971, and expected medical benefit as compared to available alternatives. This part of ANSI/AAMI/ISO 22442 is intended to provide requirements and guidance on risk managem

28、ent related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives. Keywords: animal tissue, non-viable, transmissible agents, risk management AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of

29、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 products, processes, or procedures not conforming to the standar

30、d. 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, revise, or withdraw this standard no later than five years fr

31、om 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 documents developed by AAMI are voluntary, and their application is s

32、olely 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 responsible for enforcement of its rules and regulations. Publ

33、ished by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this publication may be reproduced or distribute

34、d in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests 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

35、 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 per offense. For permission regarding the use of all or any part of this document, comp

36、lete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-665-8 Contents Page Glossary of equivalent standards . iv Committee repres

37、entation. v Background of ANSI/AAMI adoption of ISO 22442-1:2016 . vi Foreword . vii Introduction . viii 1 Scope 1 2 Normative references . 1 3 Terms and definitions . 2 4 Risk management process 3 Annex A (informative) Guidance on the application of this part of ISO 22442 . 7 Annex B (informative)

38、Graphical representation of part of the risk management process for medical devices utilizing animal material. 8 Annex C (normative) Special requirements for some animal materials considering the risk management for TSE agents . 10 Annex D (informative) Information relevant to the management of TSE

39、risk . 15 Bibliography . 23 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 22442-1:2016 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current l

40、ist of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Adv

41、ancement of Medical Instrumentation ANSI/AAMI/SO 22442-1:2016 v Committee representation Association for the Advancement of Medical Instrumentation Tissue Product Safety Committee The adoption of ISO 22442-1 as an AAMI standard was initiated by the AAMI Tissue Product Safety Committee, which also fu

42、nctions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Tissue Product Safety Committee (U.S. TAG for ISO/TC 194/SC 1), chaired by Rich Hutchinson and Scott McNamee, played an active part in devel

43、oping the ISO Standard. Committee approval of this document does not necessarily imply that all committee members voted for its approval. At the time this standard was published, the AAMI Tissue Product Safety Committee had the following members: Cochairs: Richard Hutchinson Scott McNamee Members: C

44、rystal Anderson-Cunanan, Boston Scientific Corporation Scott Brubaker, American Association of Tissue Banks Kim Darnell, CR Bard Steven Elliott, NAMSA Gary Fischman, National Academies Deborah Gessell-Lee, Baxter Healthcare Corporation Richard Hutchinson, Johnson b) contamination by viruses; c) cont

45、amination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This part of ISO 22442 does not stipulate le

46、vels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an International Standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk a

47、nd milk derivatives, wool derivatives and amino acids. This part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a req

48、uirement of this part of ISO 22442 to have a full quality management system during manufacture. However, attention is drawn to International Standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. NOTE 2 For guidance on the a

49、pplication of this part of ISO 22442, see Annex A. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process ISO 14971, Medical devicesApplication of risk management to medical devices ISO 22442-2, Medical