1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58oral and maxillofacial surgery Contents of a technical fileThe European Standard EN ISO 22803:2005
2、has the status of a British StandardICS 11.060.15Dentistry Membrane materials for guided tissue regeneration in BRITISH STANDARDBS EN ISO 22803:2005BS EN ISO 22803:2005This British Standard was published under the authority of the Standards Policy and Strategy Committee on 13 January 2006 BSI 13 Jan
3、uary 2006ISBN 0 580 47380 5Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the B
4、SI Electronic Catalogue or of British Standards Online.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations.Summary of p
5、agesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 7 and a back cover.The BSI copyright notice displayed in this document indicates when the document was last issued.Amendments issued since
6、 publicationAmd. No. Date CommentsA list of organizations represented on this subcommittee can be obtained on request to its secretary. present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor re
7、lated international and European developments and promulgate them in the UK.National forewordThis British Standard is the official English language version of EN ISO 22803:2005. It is identical with ISO 22803:2004.The UK participation in its preparation was entrusted by Technical Committee CH/106, D
8、entistry, to Subcommittee CH/106/8, Dental implants, which has the responsibility to: aid enquirers to understand the text;EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 22803November 2005ICS 11.060.15English VersionDentistry - Membrane materials for guided tissue regeneration inoral and maxi
9、llofacial surgery - Contents of a technical file (ISO22803:2004)Art dentaire - Membranes pour rgnration de tissus enchirurgie buccale et maxillo-faciale - Contenu du dossiertechnique (ISO 22803:2004)Zahnheilkunde - Membranmaterialien fr die gesteuerteGeweberegeneration bei oralen und maxillofazialen
10、Eingriffen - Inhalt der Technischen Dokumentation (ISO22803:2004)This European Standard was approved by CEN on 7 October 2005.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 wi
11、thout any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language m
12、ade by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, G
13、reece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre:
14、rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 22803:2005: EForeword The text of ISO 22803:2004 has been prepared by Technical Committee ISO/TC 106 “Dentistry” of the International Organi
15、zation for Standardization (ISO) and has been taken over as EN ISO 22803:2005 by Technical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement,
16、at the latest by May 2006, and conflicting national standards shall be withdrawn at the latest by May 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czec
17、h Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22803:2004 has been app
18、roved by CEN as EN ISO 22803:2005 without any modifications. EN ISO 22803:2005INTERNATIONALSTANDARDISO22803First edition2004-09-01Reference numberISO 22803:2004(E)Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical fileArt dentaire Me
19、mbranes pour rgnration de tissus en chirurgie buccale et maxillo-faciale Contenu du dossier techniqueEN ISO 22803:2005iiiiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies(ISO member bodies). The work of preparing International S
20、tandards is normally carried out through ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also t
21、ake part in the work. ISO collaborates closely with the InternationalElectrotechnical 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
22、to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility th
23、at some of the elements of this document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 22803 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants.EN ISO 22803:2005ivIntroductionDifferen
24、t materials used for the preservation of masticatory function, such as dental restorative materials anddental implants are subject to standards and regulations, either in existence or in preparation, designed toevaluate the performance of these products.Membrane materials for periodontal tissue reco
25、nstruction in oral and maxillofacial surgery are not covered bythe procedures for evaluating and testing dental restorative materials and dental implants, thus it is necessaryto develop a new International Standard for these materials.The aim of this International Standard is to define the content o
26、f a technical file that demonstrates safety andeffectiveness of membrane materials used in oral and maxillofacial surgery.EN ISO 22803:20051Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical file1ScopeThis International Standard give
27、s the requirements for a technical file on the evaluation of the chemical,physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whetherresorbable, partially resorbable or non-resorbable, which are used for guided tissue regeneration in oral and maxillofacial surg
28、ery to correct a morphological defect orabnormality, in contact with teeth and/or dental implants, for prevention of epithelial migration in periodontal surgery, for the augmentation of bone prior to the planned insertion of dental implants, and/or for augmentation of bone for stabilization of denta
29、l prostheses.This International Standard is not applicable to materials whose primary intended use is to deliver a medicinalproduct, autografts and allografts, or materials intended to act through pharmacological, immunological ormetabolic means.2 Normative referencesThe following referenced documen
30、ts are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO 1942, Dentistry Vocabulary1)ISO 10993-1, Biological evaluation of medical device
31、s Part 1: Evaluation and testingISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residualsISO 11134, Sterilization of health care products Requirements for validation and routine control Industrialmoist heat sterilizationISO 11135, Sterilization of health ca
32、re products Ethylene oxide Requirements for development, validationand routine control of a sterilization process for medical devicesISO 11137, Sterilization of health care products Requirements for validation and routine control RadiationsterilizationISO 11607, Packaging for terminally sterilized m
33、edical devicesISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirementsISO 14937, Sterilization of health care products General requirements for characterization of a sterilizingagent and the development, validation and routine control of a sterilization
34、process for medical devices1) Revision of ISO 1942-1:1989, ISO 1942-2:1989, ISO 1942-3:1989, ISO 1942-4:1989 and ISO 1942-5:1989.EN ISO 22803:20052ISO 14971, Medical devices Application of risk management to medical devicesISO 15223, Medical devices Symbols to be used with medical device labels, lab
35、elling and information to besuppliedEN 1041, Information supplied by the manufacturer with medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.3.1 periodontal tissueall tissues constituting the dental periodonti
36、um, i.e. alveolar bone, gingival tissue, periodontal ligament andcementum3.2 biocompatibilitymaterial action capacity of a material to fulfill its function with an appropriate response for a specific applicationin the recipient3.3 biocompatibilitymaterial reaction quality of being accepted in a spec
37、ific living environment without adverse or unwanted sideeffectsISO 1942-1:1989/Amd.5:1993, definition 1.2003.4 biomaterialgeneral purpose material intended to interface with the biological system to evaluate, treat, augment orreplace tissue, organ or function of the organism3.5 biomaterialtailored p
38、reparation material specially prepared and/or presented to exhibit bioacceptability, biocompatibility orpositive biocompatiblityISO 1942-1:1989/Amd.5:1993, definition 1.204NOTE The implantable materials referred to in this International Standard are all biomaterials.3.6 membrane materialmedical devi
39、ce specifically prepared as a material which, when placed into tissue, carries out a barrier functionNOTE The sheet may be occlusive or selectively permeable to cells, macromolecules and/or fluid.3.7 barrierstructure which, when placed into tissue, prevents the intermixing of the cell population on
40、each side of thestructure and/or prevents the prolapse of tissue3.8 packingsurgical placement of a biomaterial to fill an intrabony cavity or defectEN ISO 22803:200533.9 augmentationsurgical placement of autogenous bone and/or of a biomaterial, resorbable or non-resorbable, to increase thevolume of
41、a bone or bridging of a defect3.10 resorbableability of a membrane material to undergo progressive elimination by cellular activity and/or dissolution in abiological environment3.11 tissue regenerationreproduction or reconstruction of a lost or injured tissue by induction, conduction or healing proc
42、ess3.12 guided tissue regenerationGTRformation of tissue among which the orientation, the function, the volume and the place are pre-modelled by anexogenous mean3.13 guided bone regenerationGBRbone formation specifically obtained by GTR principles4 General descriptionMembrane materials are widely us
43、ed in periodontology and oral and maxillofacial surgery, and havecharacteristics which are unique to these applications, for example:a) placement in contact with teeth and their supporting tissues;b) prevention of oral mucosal epithelial migration into surgically treated defects;c) predictable loss
44、of structural integrity and mechanical properties over time in oral sites into which dentalimplants are to be subsequently placed;d) known behaviour of the material should it become inadvertently exposed to the oral or paranasal cavitiessubsequent to placement;e) augmentation of the volume or dimens
45、ion of bone for enhanced stabilization of dentures or for placement ofdental implants.The development of membrane materials shall be considered with regard to the properties required for theintended purpose, taking into account the effects of manufacture, handling, sterilization and storage. Possibl
46、ereactions (intended or not) of membrane materials with human tissues and body fluids, other materials, otherimplants, substances, gases, radiation and electromagnetic fields shall be considered.Membrane materials for periodontal tissue reconstruction in oral and maxillofacial surgery are used as ei
47、ther abarrier or a covering of packing materials.During their use, these materials can induce an acute inflammatory reaction, which must be evaluated byspecific tests.EN ISO 22803:200545 Contents of a technical file5.1 GeneralThe contents of a technical file shall include the following information a
48、bout the membrane material:a) details of its chemical composition;b) its intended performance;c) its preclinical and clinical evaluations;d) details of its manufacture, sterilization and packaging;e) certain other items of information necessary for the user.5.2 Chemical compositionRefer to ISO 10993
49、-13, ISO 10993-14, ISO 10993-15 and ISO 10993-18 for guidance. All polymercharacterization shall be completed after recommended sterilization procedures have been applied.5.3 Intended performanceThe intended performance of a membrane material shall be described and documented by addressing thefollowing: general description of the product; functional characteristics: resorbable, partially resorbable or non-resorbable; typical intended applications: simple barrier (in this cas
