EN ISO 10451-2010 en Dentistry - Contents of technical file for dental implant systems《牙科植入系统 技术文件的内容》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 10451:2010Dentistry Contents oftechnical file for dental implantsystems (ISO 10451:2010)BS EN ISO 10451:2010 BRITISH STANDARDNational forewordThis British Standard is t

2、he UK implementation of EN ISO10451:2010. It supersedes BS EN ISO 10451:2002 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/8, Dental implants.A list of organizations represented on this committee can beobtained on request to its secretary.This

3、publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 62659 3ICS 11.060.15Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under th

4、e authority of theStandards Policy and Strategy Committee on 31 July 2010Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10451 June 2010 ICS 11.060.15 English Version Dentistry - Contents of technical file for dental implant systems (ISO

5、10451:2010) Mdecine bucco-dentaire - Contenu du dossier technique pour les systmes dimplants dentaires (ISO 10451:2010)Zahnheilkunde - Inhalt der Technischen Dokumentation fr Dentalimplantatsysteme (ISO 10451:2010) This European Standard was approved by CEN on 26 May 2010. CEN members are bound to c

6、omply 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 lists and bibliographical references concerning such national standards may be obtained on application to the CEN Mana

7、gement 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 responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as

8、the official versions. CEN members are the national standards bodies of 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, Roma

9、nia, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved

10、worldwide for CEN national Members. Ref. No. EN ISO 10451:2010: EBS EN ISO 10451:2010EN ISO 10451:2010 (E) 3 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 w

11、hich 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, at the latest by December 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. Attention is drawn to the

12、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 supersedes EN ISO 10451:2002. According to the CEN/CENELEC Internal Regulations, the national stan

13、dards organizations of the following countries are bound to implement 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,

14、Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland 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. BS EN ISO 10451:2010ISO 10451:2010(E) ISO 2010 All rights reserved iiiForeword ISO

15、 (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 committees. Each member body interested in a subject for which a technical com

16、mittee has been established 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 closely with the International Electrotechnical Commission (IEC) on all matters of electrot

17、echnical 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 Standards adopted by the technical committees are circulated to the mem

18、ber 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 subject of patent rights. ISO shall not be held responsible for identify

19、ing any or all such patent rights. ISO 10451 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants. This second edition cancels and replaces the first edition (ISO 10451:2002) which has been technically revised. BS EN ISO 10451:2010ISO 10451:2010(E) iv ISO 201

20、0 All rights reservedIntroduction Legal/regulatory requirements on the documentation of the design, manufacture and performance 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

21、is becoming more so, concern is growing as to the need for international and mutually recognized standards for documentation of the design and the performance of such devices. BS EN ISO 10451:2010INTERNATIONAL STANDARD ISO 10451:2010(E) ISO 2010 All rights reserved 1Dentistry Contents of technical f

22、ile for dental implant systems 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 part thereof that remains in the mouth after surgery. This International

23、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 technical file. 2 Normative references The following referenced documents are ind

24、ispensable 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, Technical drawings Indication of dimensions and tolerances Part 1: General princ

25、iples 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 times ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluat

26、ion 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 identification and quantification of potential degradation products ISO 11

27、135-1, 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 products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 ISO

28、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 Radiation Part 2: Establishing the sterilization dose ISO 11137-3, Steriliza

29、tion of health care products Radiation Part 3: Guidance on dosimetric aspects BS EN ISO 10451:2010ISO 10451:2010(E) 2 ISO 2010 All rights reservedISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 116

30、07-2, 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 14155-2, Clinical investigation of medical devices for huma

31、n 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 implants ISO 14937, Sterilization of health care products

32、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 17664, Sterilization of medical devices Information to

33、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 process for medical devices ISO/TS 22911, Dentistry Preclinic

34、al 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 cover a surface of an implant or part of an implant sys

35、tem 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 and insertion of the dependent prosthesis 3.3 technical

36、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 BS EN ISO 10451:2010ISO 10451:2010(E) ISO 201

37、0 All rights reserved 34 Requirements 4.1 General A technical file of a dental implant system shall include at least the contents described in 4.2 to 4.15. Documentation may contain data from the scientific literature as well as from specifically performed tests. If information on more than one prop

38、erty can be obtained from a single test, it is not necessary to conduct separate tests for each property. 4.2 Intended use The intended use shall be stated. Device specific indications and contra-indications shall be given. 4.3 Design characteristics The following information on the design character

39、istics shall be provided: a) Design justification: justification for the specific design shall be given. b) Dimensions: technical drawings showing the dimensions and their tolerances shall be provided. It is recommended that tolerances be stated in accordance with ISO 129-1 and ISO 14405-2. c) Surfa

40、ce finish: a description of the required surface finish, its characterization and the test method(s) used for characterization shall be given. 4.4 Properties of the constituent materials The following information on the properties of the constituent materials and the test methods used to establish t

41、hese properties shall be provided where appropriate: a) Chemical properties, including electrochemical properties: 1) chemical composition, to a sum of 100 % by mass, including all additives; 2) relevant impurities and their upper limits; 3) solubility and the test method used; 4) degradation and th

42、e test method used; 5) information on possible combinations of materials and their interactions; 6) for polymeric materials: water sorption and the test method used; 7) for metals: corrosion data and electrochemical properties, and the test methods used. b) Physical properties: 1) degree of radio-op

43、acity; 2) magnetic properties (ferromagnetic or non-ferromagnetic); 3) surface porosity (pore size and distribution); 4) crystallographic characteristics; 5) melting range, where relevant for use. BS EN ISO 10451:2010ISO 10451:2010(E) 4 ISO 2010 All rights reservedc) Mechanical properties: 1) metall

44、ic materials: i) condition of the material (cold worked, heat treated, etc.); ii) proof stress of non-proportional elongation (yield strength); iii) tensile strength; iv) total elongation at fracture (%); v) elastic modulus; 2) ceramic materials (excluding coatings): i) flexural strength and test me

45、thod; ii) fracture toughness; 3) polymeric materials: i) flexural strength; ii) elastic modulus. NOTE Methods for the determination of flexural properties are given in ISO 178. 4.5 Properties of the final product For any property which cannot be deduced from the constituent material(s), results of t

46、he following tests and the test methods for the final product shall be provided where appropriate: a) Fatigue testing: results of fatigue testing in accordance with ISO 14801, if applicable in combination with a recommended interconnecting part to a superstructure. b) Adhesive strength of a coating:

47、 for a coated implant or part of an implant system, results of testing of the strength of adhesion of the coating to the substrate material(s) and a description of the test method. c) Biological properties: results of the biological evaluation and testing of the final product and a justification for

48、 the selection of the tests. References for biological evaluation and testing are given in 4.9. d) Degradation: results of degradation tests in accordance with ISO 10993-9. 4.6 Reference to previous generation(s) or similar devices Where development and/or evaluation of the implant system is based o

49、n one or more former generation(s) or similar device(s) that have already been marketed, a reference shall be given for information on these devices. 4.7 Risk assessment Documentation of the risk analysis and risk assessment in accordance with ISO 14971 shall be provided. BS EN ISO 10451:2010ISO 10451:2010(E) ISO 2010 All rights reserved 54.8 Control of infection and microbial contamination The following information shall be provided: a) Disinfection A description of the provision