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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1642 : 1997 The Eur
2、opean Standard EN 1642 : 1996 has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dentistry Medical devices for dentistry Dental implants Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled
3、 Copy, (c) BSI BS EN 1642 : 1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 April 1997 BSI 1997 The following BSI references relate to the work on thi
4、s standard: Committee reference CH/59 Draft for comment 94/508362 DC ISBN 0 580 27141 2 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/59, Dental implants,
5、 upon which the following bodies were represented: Association of Dental Hospitals of the United Kingdom Association of Dental Implantology British Dental Association British Society for the Study of Prosthetic Dentistry Department of Health Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:
6、03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1642 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 16423 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS
7、 EN 1642 : 1997 National foreword This British Standard has been prepared by Technical Committee CH/59 and is the English language version of EN 1642 : 1996 Dentistry Medical devices for dentistry Dental implants, published by the European Committee for Standardization (CEN). Cross-references Public
8、ation referred toCorresponding British Standard EN 540BS EN 540 : 1993 Clinical investigation of medical devices for human subjects EN 550BS EN 550 : 1994 Sterilization of medical devices Validation and routine control of ethylene oxide sterilization EN 552BS EN 552 : 1994 Sterilization of medical d
9、evices Validation and routine control of sterilization by irradiation EN 556BS EN 556 : 1995 Sterilization of medical devices Requirements for terminally-sterilized devices to be labelled Sterile EN 980BS EN 980 : 1997 Graphical symbols for use in the labelling of medical devices EN 1641BS EN 1641 :
10、 1997 Dentistry Medical devices for dentistry Materials BS EN 21942 Dental vocabulary EN 21942-1Part 1 : 1992 General and clinical terms EN 21942-2Part 2 : 1993 Dental materials EN 28601BS EN 28601 : 1992 Specification for representation of dates and times in information interchange EN 30993-1 BS EN
11、 30993 Biological evaluation of medical devices Part 1 : 1994 Guidance on selection of tests EN 30993-3Part 3 : 1994 Test for genotoxicity, carcinogenicity and reproductive toxicity EN 30993-4Part 4 : 1994 Selection of tests for interactions with blood EN 30993-5Part 5 : 1994 Tests for cytotoxicity,
12、 in vitro methods EN 30993-6Part 6 : 1995 Test for local effects after implantation EN ISO 1942-5 BS EN ISO 1942 Dental vocabulary Part 5 : 1995 Terms associated with testing EN ISO 10993-10 BS EN ISO 10993 Biological evaluation of medical devices Part 10 : 1996 Tests for irritation and sensitizatio
13、n EN ISO 10993-11Part 11 : 1996 Tests for systemic toxicity Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 8, an inside back cov
14、er and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 199
15、6 Copyright reserved to CEN and its members. Ref. No. EN 1642 : 1996 E EUROPEAN STANDARDEN 1642 NORME EUROPE ENNE EUROPA ISCHE NORM August 1996 ICS 11.060.10 Descriptors: Dentistry, dental implant, specifications, information, labelling, technical notices English version Dentistry Medical devices fo
16、r dentistry Dental implants Art dentaire Dispositifs me dicaux pour lart dentaire Implants dentaires Zahnheilkunde Medizinprodukte fu r die Zahnheilkunde Dentalimplantate This European Standard was approved by CEN on 1996-07-04. CEN members are bound to comply with the CEN/CENELEC Internal Regulatio
17、ns 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 Central Secretariat or to any CEN member. This Europe
18、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 Central Secretariat has the same status as the official versions. CEN members are the nation
19、al standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c
20、) BSI Page 2 EN 1642 : 1996 BSI 1997 Foreword This standard has been prepared by Technical Committee CEN/TC 55, Dentistry, the Secretariat of which is held by DIN. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association
21、 and supports essential requirements of the EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsem
22、ent, at the latest by February 1997, and conflicting national standards shall be withdrawn at the latest by February 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgiu
23、m, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. There are three levels of European Standards dealing with medical devices used in dentistry. These are as follows. Level 1: General requiremen
24、ts for medical devices. Level 2: Particular requirements for families of medical devices used in dentistry. Level 3: Specific requirements for types of medical devices used in dentistry. There are no level 1 standards written exclusively in respect of medical devices used in dentistry. This standard
25、 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 see EN 1641). It also indicates that there are additional requirements in the level 3 standards. Where available, these a
26、re 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 informative annex A a reference for guidance on the classification of medical devices used in dentistry 3 is given. Contents Page Forew
27、ord2 1Scope3 2Normative references3 3Definitions3 4Requirements3 Annex A(informative) Bibliography6 ZA(informative) Clauses of this European Standard addressing essential requirements of other provisions of EU Directives7 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006
28、, Uncontrolled Copy, (c) BSI Page 3 EN 1642 : 1996 BSI 1997 1 Scope This European Standard specifies general requirements for dental implants. Surgically implantable dental materials defined as restorative materials are specifically excluded and described in EN 1641. This standard includes requireme
29、nts for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. 2 Normative references This European Standard incorporates by dated or undated reference provisions from other publications. These normative refere
30、nces are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the l
31、atest edition of the publication referred to applies. EN 540Clinical investigation of medical devices for human subjects EN 550Sterilization of medical devices Validation and routine control of ethylene oxide sterilization EN 552Sterilization of medical devices Validation and routine control of ster
32、ilization by irradiation EN 556Sterilization of medical devices Requirements for medical devices to be labelled STERILE EN 980Graphical symbols for use in the labelling of medical devices prEN 1041Information supplied by the manufacturer with medical devices EN 1641Dentistry Medical devices for dent
33、istry Materials EN 21942-1Dental vocabulary Part 1: General clinical terms EN 21942-2Dental vocabulary Part 2: Dental materials EN 28601Data elements and interchange formats Information interchange Representation of dates and times EN 30993-1Biological evaluation of medical devices Part 1: Guidance
34、on selection of tests EN 30993-3Biological evaluation of medical devices Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity EN 30993-4Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood EN 30993-5Biological evaluation of medical devic
35、es Part 5: Tests for cytotoxicity In vitro methods EN 30993-6Biological evaluation of medical devices Part 6: Test for local effects after implantation EN ISO 1942-5Dental vocabulary Part 5: Terms associated with testing prEN ISO 7405Biological evaluation of dental materials EN ISO 10993-10 Biologic
36、al evaluation of medical devices Part 10: Tests for irritation and sensitization EN ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity 3 Definitions For the purposes of this standard the definitions of EN 21942-1, EN 21941-2, EN ISO 1942-5 and the following de
37、finition apply: dental implant Device designed to be placed surgically within or on the mandibular or maxillary bone to provide resistance to displacement of a dental prosthesis. NOTE. The term dental implant includes transendodontic implants. 4 Requirements 4.1 General 4.1.1 Dental implants shall c
38、omply with the requirements which are applicable to them bearing in mind the intended purpose of the implant concerned. Conformity with these requirements shall be considered to be met by demonstrating compliance with the following subclauses, as appropriate. 4.1.2 For dental implants a risk analysi
39、s shall be carried out and documented. NOTE. EN 1441 describes a procedure for carrying out and documenting a risk analysis of medical devices. 4.2 Design and properties 4.2.1 Dental implants shall be manufactured from materials selected with regard to the properties required for the intended purpos
40、e. NOTE. Further information is given in ISO/TR 10451. 4.2.2 Dental implants shall be assessed for biocompatibility using the method of selection and test methods given in EN 30993-1 and the appropriate test methods in EN 30993-3, EN 30993-4, EN 30993-5, EN 30993-6, EN ISO 10993-10, EN ISO 10993- 11
41、 and prEN ISO 7405. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1642 : 1996 BSI 1997 4.3 Control of contamination 4.3.1 General 4.3.1.1 If dental implants are provided both in sterile and non-sterile conditions the condition in
42、 which they are supplied shall be clearly indicated. 4.3.1.2 Dental implants shall be manufactured under such conditions so as to minimize microbial or other contamination. 4.3.2 Dental implants supplied sterile 4.3.2.1 Dental implants supplied sterile shall comply with EN 556. 4.3.2.2 Sterilization
43、 processes shall be validated and routinely controlled: a) if dental implants are to be sterilized by ethylene oxide, EN 550 shall apply; b) if dental implants are to be sterilized by irradiation, EN 552 shall apply. 4.3.2.3 Packaging systems for dental implants supplied sterile shall be such that t
44、he implants remain sterile until the package is opened. 4.3.3 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
45、immediately prior to use the method of sterilization shall be 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. 4.4 Dental implan
46、ts used 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. 4.5 Clinical investigation Clinical investigation of
47、dental implants shall be conducted in accordance with EN 540. 4.6 Marking, labelling and information supplied by the manufacturer 4.6.1 General Information required for the safe use of dental implants shall be provided by the manufacturer in accordance with EN 980, prEN 1041, relevant product standa
48、rds, and 4.6.2, 4.6.3 and 4.6.4. 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 Labelling 4.6.3.1 The label shall include the following minimum information: a) name or regist
49、ered trade mark and address of the manufacturer. In the case of imported dental implants the name and address of the authorized representative of the manufacturer in the EU; b) description of the dental implant, including name, size and material(s); c) the word Sterile or the symbol STERILE, the method of sterilization and the recommended method of opening the pack to ensure sterile presentation at time of use, if appropriate; d) batch code, preceded by the word LOT or the symbol LOT , or the ser