1、ANSI/AAMI/ISO 10993-15:2000/(R)2011Biological evaluation of medical devices Part 15:Identification and quantification of degradation products from metals and alloysAmerican National StandardThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and
2、 potential uses of an AAMIproduct standard or recommended practice are clearly understood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effec
3、tive application of current technologiesto patient care, and (2) the encouragement of new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives
4、and provided that arbitrary and restrictive uses are avoided.A voluntary standard for a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical u
5、se, and the measurementtechniques that can be used to determine whether the device conformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including pe
6、rformance characteristics, instructions for use, warningsand precautions, and other data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized te
7、st methods to facilitateuniformity in reporting; 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
8、 reasons for 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
9、ensure that a 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, event
10、hough a recommended 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
11、to industrial 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 determi
12、ning whether 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 orprocureme
13、nt authorities). 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 represent
14、atives, whose 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,h
15、owever, in the 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 r
16、eview and revision (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 itsprovi
17、sions. This review 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
18、 risks with existing 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 volunta
19、ry standard can 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
20、 of the individual 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 so
21、urces of informationand 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 off
22、icial interpretation 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 inte
23、rpre-tation in 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 pro
24、cedure and which is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI/ISO 10993-15:2000/(R)2011Biological evaluation of medical devicesPart 15:Identification and quantification of degradationproducts from metals and alloysApproved
25、 16 October 2000 byAssociation for the Advancement of Medical InstrumentationApproved 1 November 2000 and reaffirmed 16 November 2011 byAmerican National Standards Institute, Inc.Abstract: This standard provides guidance on general requirements for the design of tests for identifyingand quantifying
26、degradation products from finished metallic medical devices or correspondingmaterial samples finished as ready for clinical use.Keywords: metals, alloys, degradation, medical devices, biological evaluationAAMI StandardThis Association for the Advancement of Medical Instrumentation (AAMI) standard im
27、plies a consensus of thosesubstantially concerned with its scope and 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 conform
28、ing to the standard. AAMI standards are subject to periodicreview, 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 tha
29、n 5 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 documentsdeveloped by AAMI are voluntary, and their applica
30、tion is solely within the discretion and professional judgment ofthe 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 enforcement of its rulesand regulations
31、.Published byAssociation for the Advancement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795 2001 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 thi
32、s publication may be reproducedor distributed in any form, including 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 pa
33、rt of this document (whether internally or externally) without 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 a
34、ll or anypart 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 of AmericaISBN 1570201552ContentsPageGlossary of equivalent standards.vCommittee representationviiBackground of AAMI adoption
35、 of ISO 10993-15:2000viiiForeword.ixIntroductionx1 Scope12 Normative references.13 Terms and definitions.24 Degradation test methods.24.1 General24.2 Prerequisites25 Reagent and sample preparation.25.1 Sample documentation25.2 Test solution (electrolyte).25.3 Preparation of test samples.35.3.1 Test
36、samples.35.3.2 Sampling35.3.3 Sample shape35.3.4 Sample surface condition36 Electrochemical tests36.1 Apparatus.36.2 Sample preparation36.3 Test conditions.46.4 Potentiodynamic measurements46.5 Potentiostatic measurements.47 Immersion test47.1 Apparatus.47.2 Sample preparation47.3 Immersion test pro
37、cedure48 Analysis69 Test report6AnnexesA Schematic diagram of the electrochemical measuring circuit.7B Schematic drawing of an electrolytic cell8C Electrolytes for the electrochemical tests.9Bibliography.10Figures1Plot of current density versus potential, showing the start of corrosion current at Ea
38、 and breakdownpotential, Ep52Log current density versus potential plot showing the breakdown potential, Ep, at the inflection point ofthe curve.5A.1Schematic diagram of the electrochemical measuring circuit.7B.1Schematic drawing of an electrolytic cell. .8 2001 Association for the Advancement of Med
39、ical Instrumentation ! ANSI/AAMI/ISO 10993-15:2000 vGlossary of equivalent standardsInternational standards adopted in the United States may include normative references to other internationalstandards. For each international standard that has been adopted by AAMI (and ANSI), the table below gives t
40、hecorresponding U.S. designation and level of equivalency to the international standard. (Note: Documents are sortedby international designation.)Other normatively referenced international standards may be under consideration for U.S. adoption by AAMI;therefore, this list should not be considered ex
41、haustive.International designation U.S. designation EquivalencyIEC 60601-2-21:1994 andAmendment 1:1996ANSI/AAMI/IEC 60601-2-21 being prepared for publication.vi 2001 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-15:2000International designation U.S. designation Equ
42、ivalencyISO 13488:1996 ANSI/AAMI/ISO 13488:1996 IdenticalISO 14155:1996 ANSI/AAMI/ISO 14155:1996 IdenticalISO 14160:1998 ANSI/AAMI/ISO 14160:1998 IdenticalISO 14161: 2000 ANSI/AAMI/ISO 14161:2000 IdenticalISO 14937:2000 ANSI/AAMI/ISO 14937:2000 IdenticalISO 14969:1999 ANSI/AAMI/ISO 14969:1999 Identi
43、calISO 14937:2000 ANSI/AAMI/ISO 14937:2000 IdenticalISO 14971:2000 ANSI/AAMI/ISO 14971:2000 IdenticalISO 15223:2000 ANSI/AAMI/ISO 15223:2000 IdenticalISO 15225:2000 ANSI/AAMI/ISO 15225:2000 IdenticalISO 15674:2001 ANSI/AAMI/ISO 15674:2001 IdenticalISO 15675:2001 ANSI/AAMI/ISO 15675:2001 IdenticalISO
44、 TS 15843:2000 ANSI/AAMI/ISO TIR15843:2000 IdenticalISO TR 15844:1998 AAMI/ISO TIR15844:1998 IdenticalISO TR 16142:1999 ANSI/AAMI/ISO TIR16142:2000 Identical 2001 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-15:2000 viiCommittee representationAssociation for the A
45、dvancement of Medical InstrumentationBiological Evaluation CommitteeThe adoption of ISO 10993-15:2000 as an American National Standard was initiated by the AAMI BiologicalEvaluation Committee, which also functions as a U.S. Technical Advisory Group to the relevant work in theInternational Organizati
46、on for Standardization (ISO). U.S. representatives from the AAMI Degradation WorkingGroup (U.S. Sub-TAG for ISO/TC 194/WG 2), cochaired by Edward Mueller (formerly of FDA and now a consultantin Annapolis, MD), played an active part in developing the ISO standard. Mr. Mueller also serves as the conve
47、ner ofthe responsible ISO working group, ISO/TC 194/WG 2, Degradation aspects related to biological testing.At the time this document was published, the AAMI Biological Evaluation Committee had the following members:Cochairs: Donald F. Gibbons, PhDDonald E. MarloweMembers: James M. Anderson, MD, PhD
48、, Case Western Reserve UniversityEric R. Claussen, PhD, Cobe Laboratories, Inc.Roger Dabbah, PhD, U.S. Pharmacopeial Convention, Inc.Donald F. Gibbons, PhD, 3MJean A. Goggins, PhD, Consultant, San Diego, CADonald E. Marlowe, FDA Center for Devices and Radiological HealthDaniel E. McLain, PhD, Becton
49、 DickinsonEdward Mueller, Consultant. Annapolis, MDBarry F. Page, Consultant, Garner, NCHarold Stanley, DDS, American Dental AssociationPaul J. Upman, North American Science Associates, Inc.Alternates: Sumner A. Barenberg, PhD, Bernard TechnologiesSharon Northup, PhD, U.S. Pharmacopeial Convention, Inc.Mel Stratmeyer, PhD, FDA Center for Devices and Radiological HealthAt the time this document was published, the AAMI Degradation Working Group had the following members:Chair: Edward MuellerMembers: Brad Anderson, Sims Deltec, Inc.James M. Anderson, MD, PhD, Case Western Rese
