BS EN ISO 10993-14-2009 Biological evaluation of medical devices - Part 14 Identification and quantification of degradation products from ceramics (ISO 10993-14 2001)《医疗器械的生物学评价 第1.pdf

1、BS EN ISO10993-14:2009ICS 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDBiological evaluationof medical devicesPart 14: Identification andquantification of degradation productsfrom ceramics (ISO 10993-14:2001)This British Standardwas published under t

2、heauthority of the StandardsPolicy and StrategyCommittee on 30 June2009 BSI 2009ISBN 978 0 580 65825 9Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10993-14:2009National forewordThis British Standard is the UK implementation of EN ISO10993-14:2009. It is identical to ISO 10993

3、-14:2001. It supersedes BS ENISO 10993-14:2001 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/194, Biological evaluation of medical devices.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publica

4、tion does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10993-14April 2009ICS 11.100.20 Supersed

5、es EN ISO 10993-14:2001 English VersionBiological evaluation of medical devices - Part 14: Identificationand quantification of degradation products from ceramics (ISO10993-14:2001)valuation biologique des dispositifs mdicaux - Partie 14:Identification et quantification des produits de dgradationdes

6、cramiques (ISO 10993-14:2001)Biologische Beurteilung von Medizinprodukten - Teil 14:Qualitativer und quantitativer Nachweis von keramischenAbbauprodukten (ISO 10993-14:2001)This European Standard was approved by CEN on 12 April 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regul

7、ations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This Eur

8、opean Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the nati

9、onal standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and Un

10、ited Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10993-14:200

11、9: EBS EN ISO 10993-14:2009EN ISO 10993-14:2009 (E) 3 Foreword The text of ISO 10993-14:2001 has been prepared by Technical Committee ISO/TC 194 “Biological evaluation of medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10993-14:2009 by T

12、echnical Committee CEN/TC 206 “Biological evaluation of medical devices” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2009, and conflicting nati

13、onal standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersede

14、s EN ISO 10993-14:2001. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC on Medical Devices. For relationship with the EU Directive, see informative Annex ZA,

15、 which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, German

16、y, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10993-14:2001 has been approved by CEN as a EN ISO 10993-14:200

17、9 without any modification. BS EN ISO 10993-14:2009EN ISO 10993-14:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices This European Standard has been prepared under a mandate given to CEN by the Eu

18、ropean Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implement

19、ed as a national standard in at least one Member State, compliance with the clauses of this standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations

20、. Table ZA Correspondence between this European Standard and Directive 93/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 4, 5, 6 Annex I: 7.1, 7.2, 7.5 WARNING Other requirements and other EU Directives may be

21、 applicable to the product(s) falling within the scope of this standard. BS EN ISO 10993-14:2009ISO 10993-14:2001(E) ISO 2001 All rights reserved iiiContents PageForeword.ivIntroductionvi1 Scope 12 Normative references 13 Terms and definitions .24 Test procedures.24.1 Principle24.2 Testing of dental

22、 devices24.3 General testing techniques.34.4 Extreme solution test 44.5 Simulation solution test 65 Analysis of filtrate95.1 General95.2 Choice of chemicals or elements to be analysed.95.3 Sensitivity of the analysis method.96 Test report 9Bibliography11BS EN ISO 10993-14:2009ISO 10993-14:2001(E)iv

23、ISO 2001 All rights reservedForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested i

24、n a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommissio

25、n (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.Publication as an Inter

26、national Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this part of ISO 10993 may be the subject ofpatent rights. ISO shall not be held responsible for identifying any or all such patent rights.Inter

27、national Standard ISO 10993-14 was prepared by Technical Committee ISO/TC 194, Biological evaluation ofmedical devices.ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluation and testing Part 2: Animal welfare requirements Part

28、3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 8: Selection and qualification of

29、 reference materials for biological tests Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identi

30、fication and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degrad

31、ation products and leachablesBS EN ISO 10993-14:2009ISO 10993-14:2001(E) ISO 2001 All rights reserved v Part 17: Establishment of allowable limits for leachable substances using health-based risk assessment Part 18: Chemical characterization of materialsBS EN ISO 10993-14:2009ISO 10993-14:2001(E)vi

32、ISO 2001 All rights reservedIntroductionThis part of ISO 10993 consists of two tests for the biological evaluation of medical devices: an extreme solutiontest and a simulation solution test. The extreme solution test is developed as a worst-case environment and thesimulation test is developed as a v

33、ery common environment.Degradation products covered by this part of ISO 10993 are formed primarily by dissolution in an aqueousenvironment. It is recognized that additional biological factors such as enzymes and proteins can alter the rate ofdegradation. Degradation by such outside factors is not ad

34、dressed in this part of ISO 10993.It should be kept in mind that a ceramic device might have extraneous chemical phases and/or elements inextremely minor amounts. Whilst these components might not be named in the original specification, they can oftenbe suspected by the relationship that the materia

35、l in question has to other materials and the expected history of thematerials processing.Once identified and quantified, the chemical composition of the degradation products form the basis for riskassessment and, if appropriate, biological safety studies according to the principles of ISO 10993-1.BS

36、 EN ISO 10993-14:2009INTERNATIONAL STANDARD ISO 10993-14:2001(E) ISO 2001 All rights reserved 1Biological evaluation of medical devices Part 14:Identification and quantification of degradation products fromceramics1 ScopeThis part of ISO 10993 specifies two methods of obtaining solutions of degradat

37、ion products from ceramics(including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions inorder to identify the degradation products. Because of the generalized nature of this part of ISO 10993, productspecific standards, when available, that addre

38、ss degradation product formation under more relevant conditions ofuse, should be considered first.This part of ISO 10993 considers only those degradation products generated by a chemical dissociation ofceramics during in vitro testing. No degradation induced by mechanical stress or external energy i

39、s covered. It isnoted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis ofdegradation products.Because of the range of ceramics used in medical devices and the different requirements for accuracy andprecision of the results, no specific analytical te

40、chniques are identified. Further, this part of ISO 10993 provides nospecific requirements for acceptable levels of degradation products.Although these materials are intended for biomedical applications, the biological activity of these degradationproducts is not addressed in this part of ISO 10993.2

41、 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 base

42、d on this part of ISO 10993 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undatedreferences, the latest edition of the normative document referred to applies. Members of ISO and IEC maintainregisters of currently val

43、id International Standards.ISO 3310-1, Test sieves Technical requirements and testing Part 1: Test sieves of metal wire clothISO 3696, Water for analytical laboratory use Specification and test methodsISO 5017, Dense shaped refractory products Determination of bulk density, apparent porosity and tru

44、e porosityISO 6474, Implants for surgery Ceramic materials based on high purity aluminaISO 6872:1995, Dental ceramicISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testingBS EN ISO 10993-14:2009ISO 10993-14:2001(E)2 ISO 2001 All rights reservedISO 10993-9, Biological eva

45、luation of medical devices Part 9: Framework for identification and quantification ofpotential degradation products3 Terms and definitionsFor the purposes of this part of ISO 10993, the terms and definitions given in ISO 10993-1 and ISO 10993-9 as wellas the following apply.3.1ceramicstypically crys

46、tallized materials that are physically nonmetallic and chemically inorganic3.2blank discnoncoated circular plate made of the substrate material to be used in the finished device3.3retentateundissolved solids remaining in the filter paper after filtration3.4filtratesolution which passes through the f

47、ilter paper4 Test procedures4.1 PrincipleThis part of ISO 10993 consists of two tests. The first test, an extreme solution test conducted at low pH, serves asa screen for most ceramics for the observation of possible degradation products. The second test simulates a morefrequently encountered in viv

48、o pH. A flowchart of the decision process for using these test methods is given inFigure 1.The test methods described in this part of ISO 10993 shall be used for ceramics in bulk and granular form as wellas ceramic coatings.When deviations from the recommended test specimen or solution volumes are u

49、sed, full justification shall beprovided.4.2 Testing of dental devices4.2.1 GeneralThis part of ISO 10993 is intended to simulate worst-case exposure to tissue environments. For dental ceramicsexposed to the oral cavity (e.g. ceramic veneering material), a more appropriate test environment is given inISO 6872. However, for dental devices not exposed to the oral cavity, such as dental implant stems, thespecifications given in 4.4 of this part of ISO 10993 shall apply.4.2.2 Test methods for dental devices exposed to the