EN ISO 22794-2009 en Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file《牙科 口腔和上颌面外科中骨填充物和增加物用可植入材料.pdf

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1、BS EN ISO22794:2009ICS 11.060.15NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Implantable materialsfor bone filling andaugmentation in oraland maxillofacialsurgery C ontents ofa technical file (ISO22794:2007, correctedversion 2009-01-15)BS EN ISO Inc

2、orporating corrigendum June 2015BS EN ISO 22794:2009ISBN 978 0 580 90282 6Amendments/corrigenda issued since publicationDate Comments30 June 2015 Implementation of ISO corrected text 15 January 2009: corrections made to references in text and bibliographyThis British Standard was published under the

3、 authority of the Standards Policy and Strategy Committee on 30 September 2009 The British Standards Institution 2015. Published by BSI Standards Limited 2015National forewordThis British Standard is the UK implementation of EN ISO 22794:2009. It is identical to ISO 22794:2007. It supersedes BS EN I

4、SO 22794:2007 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/8, Dental implants. A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not p

5、urport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22794August 2009ICS 11.060.15 Supersedes EN ISO 22794

6、:2007 English VersionDentistry - Implantable materials for bone filling andaugmentation in oral and maxillofacial surgery - Contents of atechnical file (ISO 22794:2007, corrected version 2009-01-15)Art dentaire - Matriaux implantables de comblement et dereconstruction osseuse en chirurgie orale et m

7、axillofaciale -Contenu dun dossier technique (ISO 22794:2007, versioncorrige 2009-01-15)Zahnheilkunde - Implantierbare Materialien zum Auffllenvon Knochendefekten und zur Augmentation bei oralen undmaxillofazialen Eingriffen - Inhalt der TechnischenDokumentation (ISO 22794:2007, korrigierte Fasung 2

8、009-01-15)This European Standard was approved by CEN on 3 August 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographic

9、al references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN me

10、mber into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

11、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FORSTANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FRNORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2

12、009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 22794:2009: EBS EN ISO 22794:2009EN ISO 22794:2009(E)3 Foreword The textofISO 22794:2007, corrected version 2009-01-15 has been prepared by Technical CommitteeISO/TC 106 “Dentis

13、try” of the International Organization forStandardization(ISO) and has been taken over as EN ISO 22794:2009 by Technical Committee CEN/TC55 “Dentistry” the secretariat of whichisheld by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical

14、 textorbyendorsement, at the latestbyJanuary2010, and conflicting national standards shall be withdrawn atthe latestbyJanuary2010.Attention is drawn to the possibilitythat some of the elements of this document maybethe subject of patent rights.CEN and/or CENELEC shallnot be held responsible forident

15、ifying anyorall such patent rights. This document supersedes EN ISO22794:2007.According to the CEN/CENELEC InternalRegulations, the national standardsorganizations of the followingcountriesare bound to implement this European Standard: Austria,Belgium, Bulgaria, Cyprus, CzechRepublic, Denmark, Eston

16、ia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta,Netherlands, Norway,Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement noticeThe textofISO 22794:2007, corrected version 2009-01-15 ha

17、sbeen approved by CEN as a EN ISO 22794:2009 without anymodification.BS EN ISO 22794:2009ISO 22794:2007(E) ISO 2007 All rights reserved iiiContents PageForeword ivIntroduction v1Scope12Normative references13Terms and definitions .24Implantable materials35Technical file35.1 Contents .35.2Chemical com

18、position 35.3Physical properties45.4Intended applications, precautions, warnings and instructions45.5Preclinical and clinical evaluation .55.6 Manufacture65.7 Materials of animal origin .65.8 Sterilization.65.9Packaging.75.10 Additional information supplied by the manufacturer.7Bibliography9BS EN IS

19、O 22794:2009ISO 22794:2007(E)iv ISO 2007 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical commit

20、tees. Each member bodyinterested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith the Inter

21、national Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Sta

22、ndardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International 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 document may be the subje

23、ct of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22794 was prepared by Technical Committee ISO/TC106, Dentistry, Subcommittee SC 8, Dentalimplants. In this corrected version of ISO 22794:2007 changes have been made to the list of Normative ref

24、erences (Clause 2) and to the Bibliography. Consequently cross-references in subclauses 5.2, 5.5.5, 5.7, 5.8 and 5.9.2 have been altered. Further, new subclauses 5.5.3 and 5.5.4 have been designated with the former 5.5.3 becoming 5.5.5. BS EN ISO 22794:2009ISO 22794:2007(E) ISO 2007 All rights reser

25、ved vIntroduction Different materials used for the preservation of masticatory function, such as dental restorative materials and dental implants are subject to standards and regulations, either in existence or in preparation, designed toevaluate the performance of these products. Implantable materi

26、als for bone filling and augmentation in oral and maxillofacial surgery are not covered bythe procedures for evaluating and testing dental restorative materials and dental implants; it is necessary todevelop a new standard for these materials.The aim of this International Standard is to define the c

27、ontent of a technical file that demonstrates safetyand effectiveness of bone filling and augmentation materials used in oral and maxillofacial surgery.BS EN ISO 22794:2009BS EN ISO 22794:2009INTERNATIONAL STANDARD ISO 22794:2007(E) ISO 2007 All rights reserved 1Dentistry Implantable materials for bo

28、ne filling and augmentation in oral and maxillofacial surgery Contents of atechnical file 1 Scope This International Standard applies to implantable materials,whether resorbable or non-resorbable, used asdental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that

29、 are essentially pure ( 90 %) hydroxyapatite are not covered by this International Standard.Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.Materials such as autografts, allografts and membranes, and products f

30、or which the primary intended use is todeliver a medicinal product, are not covered by this International Standard. 2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated referen

31、ces, the latest edition of the referenceddocument (including any amendments) applies.ISO 1942 1), Dentistry VocabularyISO 10993-1 2), Biological evaluation of medical devices Part1: Evaluation and testing within a riskmanagement systemISO 10993-17, Biological evaluation of medical devices Part17: Es

32、tablishment of allowable limits forleachable substancesISO 11135-1 3), Sterilization of health care products Ethylene oxide Part1: Requirements fordevelopment, validation and routine control of a sterilization process for medical devicesISO 11137-1 4), Sterilization of health care products Radiation

33、 Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11607-2 5), Packaging for terminally sterilized medical devices Part 2: Validation requirements forforming, sealing and assembly processes1) To be published. (Revises and replaces

34、ISO 1942 parts 1 to 5:1989) 2) To be published. (Revision of ISO 10993-1:2003) 3) Cancels and replaces ISO 11135:1994 and ISO 11135:1994/Cor.1:1994. 4) Cancels and replaces ISO 11137:1995, ISO 11137:1995/Cor.1:1997 and ISO 11137:1995/Amd.1:2001. 5) Cancels and replaces ISO 11607:2003. BS EN ISO 2279

35、4:2009ISO 22794:2007(E)2 ISO 2007 All rights reservedISO 13408-1, Aseptic processing of health care products Part1: General requirementsISO 14155-1 6), Clinical investigation of medical devices for human subjects Part 1: General requirementsISO 14155-2 6), Clinical investigation of medical devices f

36、or human subjects P art2: Clinical investigationplansISO 14937, Sterilization of health care products General requirements for characterization of a sterilizingagent and the development, validation and routine control of a sterilization process for medical devicesISO 14971, Medical devices Applicati

37、on of risk management to medical devicesISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to besupplied ISO 17665-1 7), Sterilization of health care products Moist heat Part 1: Requirements for thedevelopment, validation and routine control of a ster

38、ilization process for medical devicesEN 1041, Information supplied by the manufacturer of medical devices3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1 biocompatibilitya) capability of a material to fulfil its functi

39、on with an appropriate response for a specific application from thereceiving host; b) quality of being accepted in a specific living environment without adverse or unwanted side effects3.2 biomaterial a) material intended to interface with the biological system to evaluate, treat, augment or replace

40、 tissue,organ or function of the organism; b) material specially prepared and/or presented to exhibit bioacceptability, biocompatibility or positivebiocompatiblityNOTE The implantable materials referred to in this document are all biomaterials. 3.3 filling surgical placement of a biomaterial, resorb

41、able or non-resorbable, into an intrabony cavity during oral and maxillofacial surgeryNOTE Intrabony cavity includes extraction socket. 3.4 augmentation surgical placement of a biomaterial, resorbable ornon-resorbable, to increase the volume of bone, usually on the sinus floor or the alveolar ridges

42、6) Cancels and replaces ISO 14155:1996. 7) Cancels and replaces ISO 11134:1994 and ISO 13683:1997.BS EN ISO 22794:2009ISO 22794:2007(E) ISO 2007 All rights reserved 33.5 resorptionprogressive elimination by cellular activity and/or dissolution of a material in a biological environment 3.6 medicinal

43、product substance that produces its intended effect bypharmaceutical means4 Implantable materialsThe development of implantable materials shall be considered with regard to the properties required for the intended purpose, taking into account the effects of manufacture, handling, sterilization and s

44、torage. Possiblereactions (intended or not) of implantable materials with human tissues and bodyfluids, other materials, otherimplants, substances, gases, radiation and electromagnetic fields shall be considered. Implantable materials for bone reconstruction in oraland maxillofacial surgery are used

45、 either for filling oraugmentation. 5 Technical file 5.1 ContentsThe contents of a technical file shall include at least the following: details of the chemical composition and physical properties of the implantable material; i ts intended performance; its preclinical and clinical evaluation; details

46、 of its manufacture, sterilization and packaging; all information necessary for the user (as detailed later). New materials, for which the following characterizationmethods may not be adequate, shall be characterizedusing techniques appropriate to the materials and the choice of technique shall be j

47、ustified. 5.2 Chemical compositionAs appropriate, the following shall apply.The complete chemical composition, summing to 100 % by mass, including all additives, shall be described. The crystalline and non-crystalline phases, phase purity, and the mass fractions of phases, using X-ray diffraction (X

48、RD), Fourier transform infrared spectroscopy (FTIR) and/or differential scanning calorimetry(DSC), as appropriate, shall be described. The composition description shall alsoinclude elemental analysis, identifying the cation to anion ratio (e.g., Ca/P, Ca/S) and/or the carbon/oxygen/nitrogen ratios (

49、e.g., C/O/N), as appropriate, and all trace impurities relevant to the application. Diffraction patterns,along with superimposed patterns of each phase as given for the relevant calcium salt and available from the International Center for Diffraction Data/Joint Committee on Powder Diffraction Standards (ICDD/JCPDS),shall be described. NOTE Several standards that address the specifics of different materials are available and can be useful referencesfor other bone-filling materials. See references 11, 19, 20