1、November 2010 Translation by DIN-Sprachendienst.English price group 10No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.060.15!$l1“1731496www.din.deDDIN EN ISO 10451Dentistry Contents of technical file for dental implant systems (ISO 10451:2010)English translation of DIN EN ISO 10451:2010-11Zahnheilkunde Inhalt der Technischen Dokumentation fr Dentalimplantatsysteme (ISO 10451:2010)Englische bersetzung von DIN
3、EN ISO 10451:2010-11Mdecine bucco-dentaire Contenu du dossier technique pour les systmes dimplants dentaires (ISO 10451:2010)Traduction anglaise de DIN EN ISO 10451:2010-11SupersedesDIN EN ISO 10451:2002-07www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shall be co
4、nsidered authoritative.1611.10 DIN EN ISO 10451:2010-11 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DI
5、N, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-21 AA Dentalimplantate. The DIN Standards corresponding to the International Standards referred to in Clause 2 of the EN are as follows: IS
6、O 178 DIN EN ISO 178 ISO 1942 DIN EN ISO 1942 ISO 5832-2 DIN ISO 5832-2 ISO 5832-3 DIN ISO 5832-3 ISO 6507-1 DIN EN ISO 6507-1 ISO 6892-1 DIN EN ISO 6892-1 ISO 7405 DIN EN ISO 7405 ISO 8601 DIN ISO 8601 ISO 9001 DIN EN ISO 9001 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-7 DIN EN ISO 10993-7 ISO 10993-
7、9 DIN EN ISO 10993-9 ISO 11135-1 DIN EN ISO 11135-1 ISO 11137-1 DIN EN ISO 11137-1 ISO 11137-2 DIN EN ISO 11137-2 ISO 11137-3 DIN EN ISO 11137-3 ISO 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 13485 DIN EN ISO 13485 ISO 14155-1 DIN EN ISO 14155-1 ISO 14155-2 DIN EN ISO 14155-2 ISO
8、14405-2 DIN EN ISO 14405-2 ISO 14801 DIN EN ISO 14801 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 17664 DIN EN ISO 17664 ISO 17665-1 DIN EN ISO 17665-1 ISO/TS 11135-2 DIN ISO/TS 11135-2 DIN EN ISO 10451:2010-11 3 Amendments This standard differs from DIN EN ISO 10451:2002-07 as follows
9、: a) the structure of the technical product file has been brought in line with the requirements of the “Global Harmonization Group”; b) requirements and appropriate normative references have been updated; c) requirements regarding the biological evaluation and clinical investigation have been render
10、ed more precise. Previous editions DIN EN ISO 10451: 2002-07 National Annex NA (informative) Bibliography DIN EN ISO 178, Plastics Determination of flexural properties DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 6507-1, Metallic materials Vickers hardness test Part 1: Test method DIN EN ISO 68
11、92-1, Metallic materials Tensile testing Part 1: Method of test at room temperature DIN EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry DIN EN ISO 9001, Quality management systems Requirements DIN EN ISO 10993-1, Biological evaluation of medical devices Par
12、t 1: Evaluation and testing within a risk management system DIN EN ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals DIN EN ISO 10993-9, Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential de
13、gradation products DIN EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements
14、 for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose DIN EN ISO 10451:2010-11 4 DIN EN ISO 11137-3, Sterilization of health care products Radiati
15、on Part 3: Guidance on dosimetric aspects DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements
16、for forming, sealing and assembly processes DIN EN ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes DIN EN ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements DIN EN ISO 14155-2, Clinical investigation of me
17、dical devices for human subjects Part 2: Clinical investigation plans DIN EN ISO 14405-2, Geometrical product specifications (GPS) Dimensional tolerancing Part 2: Dimensions other than linear sizes DIN EN ISO 14801, Dentistry Implants Dynamic fatigue test for endosseous dental implants DIN EN ISO 14
18、971, Medical devices Application of risk management to medical devices DIN EN ISO 17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: R
19、equirements for the development, validation and routine control of a sterilization process for medical devices DIN ISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titanium DIN ISO 5832-3, Chirurgische Implantate Metallische Werkstoffe Teil 3: Titan-Aluminium-6-Vanadium-4-Knetle
20、gierung DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times DIN ISO/TS 11135-2, Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1
21、0451 June 2010 ICS 11.060.15 English Version Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010) Mdecine bucco-dentaire - Contenu du dossier technique pour les systmes dimplants dentaires (ISO 10451:2010)Zahnheilkunde - Inhalt der Technischen Dokumentation fr Dentalimp
22、lantatsysteme (ISO 10451:2010) This European Standard was approved by CEN on 26 May 2010. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date li
23、sts and bibliographical references concerning such national standards 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 translation under the re
24、sponsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
25、 Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management
26、Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10451:2010: EContents PageForeword3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .6 4 Requirements.7 4
27、.1 General7 4.2 Intended use.7 4.3 Design characteristics 7 4.4 Properties of the constituent materials.7 4.5 Properties of the final product .8 4.6 Reference to previous generation(s) or similar devices .8 4.7 Risk assessment8 4.8 Control of infection and microbial contamination .9 4.9 Biological e
28、valuation.9 4.10 Clinical evaluation .9 4.11 Manufacturing process .9 4.12 Quality control of the implant manufacturing process9 4.13 Packaging .10 4.13.1 Primary container 10 4.13.2 Protection from damage in storage and transport.10 4.14 Label10 4.15 Instructions for use .11 Bibliography 12 DIN EN
29、ISO 10451:2010-11 EN ISO 10451:2010 (E) 2 Foreword This document (EN ISO 10451:2010) has been prepared by Technical Committee ISO/TC 106 Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the statu
30、s of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. Attention is drawn to the possibility that some of the elements of this document may be the su
31、bject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10451:2002. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implemen
32、t this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Switze
33、rland and the United Kingdom. Endorsement notice The text of ISO 10451:2010 has been approved by CEN as a EN ISO 10451:2010 without any modification. DIN EN ISO 10451:2010-11 EN ISO 10451:2010 (E) 3 “ Introduction Legal/regulatory requirements on the documentation of the design, manufacture and perf
34、ormance of dental implants are developing in various ways in different countries and international regions. As the dental implant industry is already active on a global basis, and is becoming more so, concern is growing as to the need for international and mutually recognized standards for documenta
35、tion of the design and the performance of such devices. DIN EN ISO 10451:2010-11 EN ISO 10451:2010 (E) 4 1 Scope This International Standard specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for a dental implant and any prefabricated
36、 part thereof that remains in the mouth after surgery. This International Standard is not applicable to instruments and other parts specifically made for the dental implant system but which do not remain in the mouth. However, documentation relating to these components may be included in the technic
37、al file. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 129-1, Techni
38、cal drawings Indication of dimensions and tolerances Part 1: General principles ISO 1942, Dentistry Vocabulary ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry ISO 8601, Data elements and interchange formats Information interchange Representation of dates and t
39、imes ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals ISO 10993-9, Biological evaluation of medical devices Part 9: Framework for
40、identification and quantification of potential degradation products ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO/TS 11135-2, Sterilization of health care produ
41、cts Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-2, Sterilization of health care products Ra
42、diation Part 2: Establishing the sterilization dose ISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects DIN EN ISO 10451:2010-11 EN ISO 10451:2010 (E) 5 ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials
43、, sterile barrier systems and packaging systems ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 1415
44、5-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans ISO 14405-2, Geometrical product specifications (GPS) Dimensional tolerancing Part 2: Dimensions other than linear sizes ISO 14801, Dentistry Implants Dynamic fatigue test for endosseous dental imp
45、lants ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Medical devices Application of risk management to medical devices ISO
46、17664, Sterilization of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization proces
47、s for medical devices ISO/TS 22911, Dentistry Preclinical evaluation of dental implant systems Animal test methods 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 coating layer of material used to cover or partially
48、cover a surface of an implant or part of an implant system 3.2 dental implant system device that consists of integrated components including the ancillary instruments and specific equipment necessary for the clinical and laboratory preparation and placement of the implant, and for the construction a
49、nd insertion of the dependent prosthesis 3.3 technical file documentation provided by the manufacturer containing the basic available information on a device or indicating its location 3.4 water sorption gain in water content, per volume, of an initially dry specimen after immersion in water for a given time DIN EN ISO 10451:2010-11 EN ISO 10451:2010 (E) 6 4 Requirements 4.1 General A technical file of a dental implant
