ANSI AAMI 10993-4-2002 Biological evaluation of medical devices - Part 4 Selection of tests for interactions with blood (Incorporates Amendment 1 2006).pdf

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1、ANSI/AAMI/ISO 10993-4: 2002/(R)2013 reaching consensus on these tests canrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for

2、establishing the criteria must bedocumented in the rationale.A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a

3、 device is usedsafely and effectively and that its performance will be maintained.Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device evaluation. Similarly, eventhough a recom

4、mended practice is usually oriented towards healthcare professionals, it may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial

5、 personnel onsuch subjects as sterilization processing, methods of collecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.In determining whether

6、an AAMI standard or recommendedpractice is relevant to the specific needs of a potential user of thedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authoritie

7、s). The application of a standard or recom-mended practice is solely within the discretion and professionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose

8、 work has been reviewed nationally(and sometimes internationally). As such, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in th

9、e sense that it responds generally to perceived risks andconditions that may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecisionmaking.Despite periodic review and rev

10、ision (at least once every fiveyears), a standard or recommended practice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This r

11、eview will reveal whether the document remainsrelevant to the specific needs of the user.Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with e

12、xisting equipment typically form the basis for thesafety and performance criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as “unsafe“. A voluntary standard c

13、an be used asone resource, but the ultimate decision as to product safety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the indiv

14、idual institution or firm. Again, the rationaleaccompanying each AAMI standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of info

15、rmationand policy guidance and in the context of professional experience andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpr

16、etation must be approved by letterballot of the originating committee and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon publication of notice of interpre-tation i

17、n the “Standards Monitor“ section of the AAMI News. TheAssociation for the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicated in accordance with this procedure and wh

18、ich is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI/ISO 10993-4:2002/(R)20 (Revision of ANSI/AAMI/ISO 10993-4:1993) Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood Approved 1 Oc

19、tober 2002 by Association for the Advancement of Medical Instrumentation Approved 31 October 2002 and reaffirmed 1RYHPEHU 20 by American National Standards Institute, Inc. Abstract: This standard gives guidance to agencies, manufacturers, research laboratories, and others for evaluating the interact

20、ions of medical devices with blood. Keywords: biological evaluation, blood, coagulation, ex vivo, hematology, medical devices, thrombosis AAMI StandardThis Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of thosesubstantially concerned with its scope an

21、d provisions. The existence of an AAMI standard does not in any respectpreclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, orusing products, processes, or procedures not conforming to the standard. AAMI standards are subject to periodicreview,

22、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 thataction be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication.Interested parties may ob

23、tain current information on all AAMI standards by calling or writing AAMI.All AAMI standards, recommended practices, technical information reports, and other types of technical documentsdeveloped by AAMI are voluntary, and their application is solely within the discretion and professional judgment o

24、fthe user of the document. Occasionally, voluntary technical documents are adopted by government regulatoryagencies or procurement authorities, in which case the adopting agency is responsible for the enforcement of itsrules and regulations.Published byAssociation for the Advancement of Medical Inst

25、rumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795 2003 by the Association for the Advancement of Medical InstrumentationAll Rights ReservedThis publication is subject to copyright claims of ISO, ANSI, and AAMI. No part of this publication may be reproducedor distributed in any form, i

26、ncluding an electronic retrieval system, without the prior written permission of AAMI. Allrequests pertaining to this draft 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) witho

27、ut the prior writtenpermission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, includingcivil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or anypart of this document, contact AAMI, 1110 N. Glebe

28、Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067.Printed in the United States of AmericaISBN 1570201803ContentsPageGlossary of equivalent standardsivCommittee representation.viBackground of ANSI/AAMI adoption of ISO 10993-4. viiForeword. viiiIntroduction .ix1 Sco

29、pe12 Normative references .13 Terms and definitions .14 Abbreviated terms.25 Types of devices in contact with blood (as categorized in ISO 10993-1) .35.1 Non-contact devices 35.2 External communicating devices .35.3 Implant devices36 Characterization of blood interactions 46.1 General requirements 4

30、6.2 Categories of tests and blood interactions.86.2.1 Recommended tests for interactions of devices with blood.86.2.2 Non-contact devices 86.2.3 External communicating devices .86.2.4 Implant devices86.2.5 Indications and limitations .86.3 Types of tests.106.3.1 In vitro tests .106.3.2 Ex vivo tests

31、 106.3.3 In vivo tests11AnnexesA Preclinical evaluation of cardiovascular devices and prostheses.12B Laboratory testsPrinciples, scientific basis, and interpretation15C Evaluation of hemolytic properties of medical devices and their components20Bibliography .25Tables1 Devices or device components wh

32、ich contact circulating blood and the categories of appropriatetestingExternal communicating devices 72 Devices or device components which contact circulating blood and the categories of appropriatetestingImplant devices.73 Test methods for external communicating devices.94 Test methods for implant

33、devices .10Figure1 Decision tree that determines whether testing for interaction with blood is necessary.6iv 2003 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-4:2002Glossary of equivalent standardsInternational Standards adopted in the United States may include no

34、rmative references to other InternationalStandards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives thecorresponding U.S. designation and level of equivalency to the International Standard.NOTEDocuments are sorted by international designation.Other nor

35、matively 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 EquivalencyIEC 60601-1-2:2001 ANSI/AAMI/IEC 60601-1-2:2001 IdenticalIEC 60601-2-21:1994 andAmendment 1:

36、1996ANSI/AAMI/IEC 60601-2-21 chapters 9 and 10. This publication hassince been revised 32. 2003 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-4:2002 1American National Standard ANSI/AAMI/ISO 10993-4:2002Biological evaluation of medical devicesPart 4: Selection of t

37、ests for interactions with blood1 ScopeThis part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.It describesa) a classification of medical and dental devices that are intended for use in contact with blood, based on theintended use and durati

38、on of contact as defined in ISO 10993-1;b) the fundamental principles governing the evaluation of the interaction of devices with blood; andc) the rationale for structured selection of tests according to specific categories, together with the principlesand scientific basis of these tests.Detailed re

39、quirements for testing cannot be specified because of limitations in knowledge and precision of tests forinteractions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and maynot necessarily provide sufficient guidance for test methods for a specific devi

40、ce.2 Normative referencesThe following normative documents contain provisions which, through reference in this text, constitute provisions ofthis part of ISO 10993. For dated references, subsequent amendments to, or revisions of, any of these publicationsdo not apply. However, parties to agreements

41、based on this part of ISO 10993 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undated references,the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers ofcurrently

42、 valid International Standards.ISO 10993-1:1997, Biological evaluation of medical devicesPart 1: Evaluation and testing.ISO 10993-2:1992, Biological evaluation of medical devicesPart 2: Animal welfare requirements.3 Terms and definitionsFor the purposes of this part of ISO 10993, the terms and defin

43、itions given in ISO 10993-1 and the following apply.3.1 blood/device interaction: Any interaction between blood or any component of blood and a device resulting ineffects on the blood, or on any organ or tissue, or on the device.NOTESuch effects may or may not have clinically significant or undesira

44、ble consequences. Annex A contains further informationon these interactions.3.2 ex vivo: Term applied to a test system that shunts blood directly from a human subject or test animal into atest chamber located outside the body.NOTEIf using an animal model, the blood may be shunted directly back into

45、the animal (recirculating) or collected into test tubesfor evaluation (single pass).3.3 thrombosis: In vivo phenomenon resulting in the partial or complete occlusion of a vessel or device by athrombus.NOTE 1Characterization of thrombosis includes ex vivo and in vivo methods, in either animals or the

46、 clinical setting.NOTE 2A thrombus is composed of a mixture of red cells, aggregated platelets, fibrin, and other cellular elements.3.4 coagulation: Phenomenon that results from activation of the clotting factor cascade.NOTEFactors of the coagulation cascade and fibrinolytic systems can be measured

47、following exposure to devices either in vitroor in vivo.2 2003 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-4:20023.5 platelet: Anuclear, cellular body that is present in the circulation which adheres to surfaces and aggregates toform a hemostatic plug to minimize

48、 bleeding.NOTEPlatelet testing includes quantification of platelet numbers as well as analysis of their structure and function. The testingcan include analysis of platelet factors, or components on the platelet surface which are released from platelets or adherent to thedevice surface.3.6 hematology

49、: Study of blood, including quantification of cellular and plasma components of the blood.3.7 complement system: Part of the innate immune system, consisting of several plasma proteins, includingenzymes and cellular receptors.NOTEEffector molecules produced from complement components are involved in inflammation, phagocytosis, and cell lysis.4 Abbreviated termsBb product of alternate pathway complement activation-TG beta-thromboglobulinC4d product of classical pathway complement activationC3a, C5a (active) complement split products from C3 and