1、ANSI/AAMI/ISO 10993-14:2001/(R)2011Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramicsAmerican National StandardThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potenti
2、al 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 effective app
3、lication 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 and prov
4、ided 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 use, and
5、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 performanc
6、e 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 test metho
7、ds 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 reasons
8、 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 ensure t
9、hat 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, eventhough a
10、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 to indus
11、trial 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 whe
12、ther 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 autho
13、rities). 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,
14、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,however,
15、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 review an
16、d 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 itsprovisions. T
17、his 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 risks w
18、ith 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 voluntary stand
19、ard 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 of the
20、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 sources of
21、 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 official in
22、terpretation 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-tat
23、ion 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 procedure a
24、nd which is notpublished, by appropriate notice, as an official interpretation in theAAMI News.American National Standard ANSI/AAMI/ISO 10993-14:2001/(R)2011?Biological evaluation of medical devicesPart 14:Identification and quantification ofdegradation products from ceramicsApproved 24 September 20
25、01 byAssociation for the Advancement of Medical InstrumentationApproved 11 October 2001 and reaffirmed 16 November 2011 byAmerican National Standards Institute, Inc.Abstract: Specifies two methods for obtaining solutions of degradation products from ceramics (includingglasses) for the purposes of qu
26、antification.Keywords: biological evaluation, degradation, ceramicsAAMI StandardThis Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of thosesubstantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect
27、preclude 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, and users are cautioned to obtain the latest editions.CAUTION NOTICE: T
28、his 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 5 years from the date of publication.Interested parties may obtain current information on all AAMI standards by calling or writing AAMI.
29、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 ofthe user of the document. Occasionally, voluntary technical documents are
30、 adopted by government regulatoryagencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rulesand regulations.Published byAssociation for the Advancement of Medical Instrumentation1110 N. Glebe Road, Suite 220Arlington, VA 22201-4795 2001 by the A
31、ssociation 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, including an electronic retrieval system, without the prior written permission
32、of AAMI. Allrequests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, etseq.) to make copies of all or any part of this document (whether internally or externally) without the prior writtenpermission of the Association for the Advancement of Me
33、dical 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 Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703
34、) 525-1067.Printed in the United States of AmericaISBN 1570201714ContentsPageGlossary of equivalent standards.vCommittee representation viiBackground of AAMI adoption of ISO 10993-14:2001 viiiForeword.ixIntroduction x1 Scope12 Normative references .13 Terms and definitions .14 Test procedures24.1 Pr
35、inciple .24.2 Testing of dental devices .24.2.1 General24.2.2 Test methods for dental devices exposed to the oral cavity34.2.3 Specimen characterization 34.2.4 Analysis .34.3 General testing techniques 34.3.1 Mass determination .34.3.2 Drying techniques34.4 Extreme solution test .34.4.1 Principle.34
36、.4.2 Application range.34.4.3 Extreme test sample preparation.34.4.3.1 Specimen configuration .34.4.3.2 Granulation 34.4.3.3 Sizing .34.4.3.4 Specimen preparation44.4.4 Extreme test sample characterization44.4.4.1 Surface area characterization44.4.4.2 Density.44.4.4.3 Solubility characterization 44.
37、4.4.4 Microstructural and X-ray characterization.44.4.5 Test equipment44.4.5.1 Test container 44.4.5.2 Bchner funnel.44.4.6 Citric acid buffer solution .44.4.7 Test procedure.44.5 Simulation solution test54.5.1 Principle.54.5.2 Application range.54.5.3 Simulation test specimen configuration.54.5.3.1
38、 Coated ceramics54.5.3.2 All other ceramics 54.5.4 Simulation test sample characterization 54.5.4.1 General 54.5.4.2 Density.64.5.4.3 Microstructural and X-ray characterization.64.5.4.4 Surface area characterization64.5.5 Test equipment64.5.5.1 Test container 64.5.5.2 Bchner funnel.64.5.6 Buffer sol
39、ution64.5.7 Coated disk test procedure64.5.7.1 General 64.5.7.2 Blank disk test64.5.7.3 Coated disk test .64.5.8 Test procedure (all other ceramics).75 Analysis of filtrate75.1 General 75.2 Choice of chemicals or elements to be analyzed.75.3 Sensitivity of the analysis method76 Test report 8AnnexBib
40、liography .9Figure1 Flowchart of the decision making process for the extreme solution test and the simulation solutiontests (see text for details)2 2001 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-14:2001 vGlossary of equivalent standardsInternational Standards a
41、dopted 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 thecorresponding U.S. designation and level of equivalency to the International Standard. (NOTE: Documents are
42、sorted by international 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 EquivalencyIEC 60601-2-21:1994 andAmendment 1:1996ANSI/AA
43、MI/IEC 60601-2-21 being prepared for publication. 2001 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI/ISO 10993-14:2001 viiCommittee representationAssociation for the Advancement of Medical InstrumentationBiological Evaluation CommitteeThe adoption of ISO 10993-14:2001 as an
44、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 Organization for Standardization (ISO). U.S. representatives from the AAMI Degradation AspectsRelated to Biological Te
45、sting Working Group (U.S. Sub-TAG for ISO/TC 194/WG 2), cochaired by Edward Mueller,formerly of FDA and now a consultant in Annapolis, MD, played an active part in developing the ISO standard. Mr.Mueller also serves as the convener of the responsible ISO working group.At the time this document was p
46、ublished, the AAMI Biological Evaluation Committee had the following members:Cochairs: Donald F. Gibbons, PhDDonald E. MarloweMembers: James M. Anderson, MD, PhD, Case Western Reserve UniversityEric R. Claussen, PhD, Becton DickinsonRoger Dabbah, PhD, U.S. Pharmacopeial Convention, Inc.Donald F. Gib
47、bons, PhD, 3MJean A. Goggins, PhD, Consultant, San Diego, CADonald E. Marlowe, FDA Center for Devices and Radiological HealthEdward Mueller, Consultant, Annapolis, MDBarry F. Page, Consultant, Garner, NCHarold Stanley, DDS, American Dental AssociationPaul Upman, NAmSAAlternates: Sumner A. Barenberg,
48、 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 Aspects Related to Biological Testing WorkingGroup had the following members:Chair: Edwar
49、d MuellerMembers: David Albert, DPM, North American Science Associates, Inc.Brad Anderson, Sims Deltec, Inc.James M. Anderson, MD, PhD, Case Western Reserve UniversityRobert R. Baier, PhD, PE, Society for BiomaterialsWilliam C. Bradbury, PhD, Viromed Biosafety LabsJon Cammack, PhD, DABT, Baxter HealthcareEric R. Claussen, PhD, Becton DickinsonCharles A. Daniels, MS, PhD, Polymer Diagnostic, Inc.Lee Ellis, Boston Scientific Corp.Gary Fischman, University of IllinoisGloria Frost, PhD, Allegiance Healthcare Corp.Donald F. Gibbons, PhD, 3MJohn Grillo, PhD, Abbott LaboratoriesEmanue
