BS EN 1642-2011 Dentistry Medical devices for dentistry Dental implants《牙科 牙科医疗器材 人工植牙》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 1642:2011Dentistry Medical devicesfor dentistry Dental implantsBS EN 1642:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 1642:20

2、11. Itsupersedes BS EN 1642:2009 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/8, Dental implants.A list of organizations represented on this committee can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 publication does not purport to include all

3、the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 76107 2ICS 11.060.15Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strat

4、egy Committee on 31 October 2011.Amendments issued since publicationDate Text affectedBS EN 1642:2011EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1642 October 2011 ICS 11.060.15 Supersedes EN 1642:2009English Version Dentistry - Medical devices for dentistry - Dental implants Mdicine bucco-d

5、entaire - Dispositifs mdicaux pour la mdicine bucco-dentaire - Implants dentaires Zahnheilkunde - Medizinprodukte fr die Zahnheilkunde - Dentalimplantate This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which s

6、tipulate 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-CENELEC Management Centre or to any CEN member. This Europe

7、an 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-CENELEC Management Centre has the same status as the official versions. CEN members are

8、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, Romania, Slovakia, Slovenia, Spain, Sweden,

9、 Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref

10、. No. EN 1642:2011: EBS EN 1642:2011EN 1642:2011 (E) 2 Contents page Foreword 3Introduction . 41 Scope 52 Normative references 53 Terms and definitions . 64 Requirements . 64.1 General 64.2 Design and properties . 64.2.1 Materials . 64.2.2 Contents of technical file 64.2.3 Biocompatibility . 64.2.4

11、Biophysical properties and modelling 64.3 Control of contamination 74.3.1 General 74.3.2 Dental implants supplied sterile . 74.3.3 Dental implants supplied non-sterile . 74.3.4 Dental implants which incorporate materials of animal origin . 74.4 Dental implants used in combination 74.5 Clinical inves

12、tigation and evaluation. 74.6 Marking, labelling and information supplied by the manufacturer 84.6.1 General 84.6.2 Symbols 84.6.3 Label 84.6.4 Instructions for use . 8Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 10Bibl

13、iography 11BS EN 1642:2011EN 1642:2011 (E) 3 Foreword This document (EN 1642:2011) has been prepared 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 t

14、ext or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the latest by April 2012. 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 responsibl

15、e for identifying any or all such patent rights. This document supersedes EN 1642:2009. 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. For relationship wit

16、h EU Directive 93/42/EEC, see informative Annex ZA, which is an integral part of this document. The following changes were made: a) normative references: 1) addition of new relevant product standards, issued after 2004: EN 1641, EN ISO 11135-1, EN ISO 11137-1, EN ISO 11607-1, EN ISO 11607-2, EN ISO

17、14801, EN ISO 14971, EN ISO 22794, EN ISO 22803; 2) deletion of the following withdrawn standards: EN 550, EN 552, EN ISO 14727; b) 4.5 Clinical evaluation: clarification of requirement for a clinical evaluation; c) 4.6.4 Instructions for use: clarification of requirement that information may be pro

18、vided in an electronic format; d) Annex ZA: actualisation of the annex. 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, Croatia, Cyprus, Czech Republic, Denma

19、rk, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. BS EN 1642:2011EN 1642:2011 (E) 4 Introduction There are three lev

20、els of European Standards dealing with medical devices used in dentistry. These are as follows: Level 1: General requirements for medical devices; Level 2: Requirements for families of medical devices used in dentistry; Level 3: Specific requirements for types of medical devices used in dentistry. T

21、here are no level 1 standards written exclusively in respect of medical devices used in dentistry. This European Standard is a level 2 standard and details requirements that apply to dental implants (for surgically implantable dental materials included within the definition of restorative materials

22、see EN 1641). It is also indicated that there are additional requirements in the level 3 standards. Where available, these are included as normative references. To cover all the requirements for a particular product, it is necessary to use a standard of the lowest available level. In the bibliograph

23、y a reference for guidance on the classification of dental devices and accessories 4 is given. BS EN 1642:2011EN 1642:2011 (E) 5 1 Scope This European Standard specifies general requirements for dental implants and accessories. Surgically implantable dental materials defined as restorative materials

24、 are specifically excluded and described in EN 1641. This European Standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. 2 Normative references The following referenced docum

25、ents 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. EN 556-1, Sterilization of medical devices Requirements for medical devices to

26、be designated “STERILE“ Part 1: Requirements for terminally sterilized medical devices EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer of medical devices EN 21942-1:1991, Dental vocabulary Part 1: General and clinical terms (ISO 1942-1:19

27、89) EN 21942-2:1992, Dental vocabulary Part 2: Dental materials (ISO 1942-2:1989) EN ISO 1942-5:1994, Dental vocabulary Part 5: Terms associated with testing (ISO 1942-5:1989) EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008) EN ISO 10451, Den

28、tal implant systems Contents of technical file (ISO 10451:2002) EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing (ISO 10993-1:2003) EN ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine

29、 control of a sterilization process for medical devices (ISO 11135-1:2007) EN 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 11137-1:2006) EN ISO 11607-1, Packaging

30、for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:

31、2006) EN ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements (ISO 14155-1:2003) EN ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14801, Dentistry Implants Dyn

32、amic fatigue test for endosseous dental implants (ISO 14801:2007) EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2007) EN ISO 22794, Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of technical f

33、ile (ISO 22794:2007) BS EN 1642:2011EN 1642:2011 (E) 6 EN ISO 22803, Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of technical file (ISO 22803:2004) ISO 8601, Data elements and interchange formats Information interchange Representation of dat

34、es and times 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 21942-1:1991, EN 21942-2:1992, EN ISO 1942-5:1994 and the following apply. 3.1 dental implants device designed to be placed surgically within or on the mandibular or maxillary bone to provid

35、e resistance to displacement of a dental prosthesis or to provide orthodontic anchorage NOTE The term dental implant includes transendodontic implants. 4 Requirements 4.1 General 4.1.1 Dental implants shall comply with the requirements which are applicable to them bearing in mind the intended purpos

36、e of the implant concerned. Conformity with these requirements shall be considered to be met by demonstrating compliance with the requirements of the following subclauses, if appropriate. 4.1.2 Risk management shall be carried out and documented. This shall include a risk analysis in accordance with

37、 EN ISO 14971. 4.2 Design and properties 4.2.1 Materials Dental implants shall be manufactured from materials selected with regard to the properties required for the intended purpose. 4.2.2 Contents of technical file The contents of the manufacturers technical file shall be in accordance with EN ISO

38、 10451, EN ISO 22794 and EN ISO 22803, if applicable. 4.2.3 Biocompatibility Dental implants shall be assessed for biocompatibility. Guidance on the selection of tests is given in EN ISO 7405 and EN ISO 10993-1. EN ISO 7405 includes usage tests specific to dental materials. Special attention shall b

39、e given to substances which are carcinogenic, mutagenic or toxic to reproduction. NOTE Further information is given in Annex I of Council Directive 67/548/EEC of 27 June 1967. 4.2.4 Biophysical properties and modelling Dental implants, other than those designed to provide orthodontic anchorage, shal

40、l be assessed for mechanical stability by fatigue testing according to EN ISO 14801. NOTE The stability of dental implants designed to provide orthodontic anchorage shall be assessed by mechanical tests with regard to the properties required for the intended purpose. BS EN 1642:2011EN 1642:2011 (E)

41、7 4.3 Control of contamination 4.3.1 General 4.3.1.1 Dental implants shall be manufactured under such conditions so as to minimize microbial or other contamination. 4.3.1.2 The condition in which dental implants are supplied shall be clearly stated, i.e. sterile, non-sterile. 4.3.2 Dental implants s

42、upplied sterile 4.3.2.1 Dental implants supplied sterile shall comply with EN 556-1. 4.3.2.2 Sterilization processes shall be validated and routinely controlled: a) If dental implants are to be sterilized by ethylene oxide, EN ISO 11135-1 shall apply; b) If dental implants are to be sterilized by ir

43、radiation, EN ISO 11137-1 shall apply. 4.3.2.3 Packaging systems for dental implants supplied sterile shall be such that the implants remain sterile until the package is opened. Packaging systems for dental implants supplied sterile shall be in accordance with EN ISO 11607-1 and EN ISO 11607-2. 4.3.

44、3 Dental implants supplied non-sterile 4.3.3.1 Packaging systems for dental implants supplied non-sterile shall maintain the level of cleanliness of the implants during transport and storage. 4.3.3.2 If dental implants are to be sterilized immediately prior to use the method of sterilization shall b

45、e given. 4.3.4 Dental implants which incorporate materials of animal origin The tissues of animal origin shall be from an approved source and shall have undergone appropriate inactivation, conservation and test procedures. NOTE Further information is given in EN ISO 22442-1 5. 4.4 Dental implants us

46、ed in combination Dental implants used in combination with prefabricated components and connecting systems other than any custom made superstructure such as a denture shall not impair the specified respective performance of any of the parts. EN ISO 10451 specifies requirements for the contents of a

47、technical file to prefabricated parts connecting a dental suprastructure to a transgingival implant. 4.5 Clinical investigation and evaluation A clinical investigation shall be conducted for all types of dental implants in accordance with EN ISO 14155-1 and EN ISO 14155-2, unless it is duly justifie

48、d and documented to rely on existing clinical data. A clinical evaluation shall be conducted and reported for all dental implants. BS EN 1642:2011EN 1642:2011 (E) 8 4.6 Marking, labelling and information supplied by the manufacturer 4.6.1 General Information required for the safe use of dental impla

49、nts shall be provided by the manufacturer in accordance with EN 980, EN 1041, 4.6.2, 4.6.3 and 4.6.4, and the following standards, if appropriate: EN ISO 10451, EN ISO 22794, EN ISO 22803. 4.6.2 Symbols Marking, labelling and instructions for use of dental implants shall, if appropriate, include information in the form of symbols as specified in EN 980. 4.6.3 Label 4.6.3.1 The label shall include the following minimum i