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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1641 : 1997 The Eur
2、opean Standard EN 1641 : 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 Materials Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy,
3、 (c) BSI BS EN 1641 : 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 this stan
4、dard: Committee reference CH/51 Draft for comment 94/508364 DC ISBN 0 580 27142 0 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/51, Prosthodontic and orth
5、odontic materials, upon which the following bodies were represented: Association of Dental Hospitals of the United Kingdom British Ceramic Research Limited British Dental Association British Dental Trade Association British Institute of Surgical Technologists British Society for Restorative Dentistr
6、y British Society for the Study of Prosthetic Dentistry British Society of Periodontology Dental Laboratories Association Limited Dental Materials Panel Department of Health Gypsum Products Development Association Institute of Materials Institute of Physics Orthodontic Technicians Association Royal
7、Society of Medicine Society of University Dental Instructors Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1641 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 16413 Li
8、censed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 1641 : 1997 National foreword This British Standard has been prepared by Technical Committee CH/51 and is the English language version of EN 1641 : 1996 Dentistry Medical device
9、s for dentistry Materials, published by the European Committee for Standardization (CEN). Cross-references Publication referred toCorresponding British Standard EN 540BS EN 540 : 1993 Clinical investigation of medical devices for human subjects EN 980BS EN 980 : 1997 Graphical symbols for use in the
10、 labelling of medical devices EN 1642BS EN 1642 : 1997 Dentistry Medical devices for dentistry Dental implants BS EN 21942 Dental vocabulary EN 21942-1Part 1 : 1992 General and clinical terms EN 21942-2Part 2 : 1993 Dental materials EN 21559BS EN 21559 : 1992 Dentistry Alloys for dental amalgam EN 2
11、1560BS 4227 : 1986 Specification for dental mercury EN 21561BS EN 21561 : 1992 Specification for dental inlay casting wax EN 21563BS 4269 Dental elastic impression material Part 2 : 1991 Specification for alginate impression material EN 21564BS EN 21564 : 1991 Specification for dental agar impressio
12、n material EN 23107BS 7214 : 1989 Specification for dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements EN 24049BS EN 24049 : 1992 Specification for resin-based dental filling materials (class B) EN 24823BS EN 24823 : 1994 Dental elastic impression materials Specification for elasto
13、meric impression materials EN 26871BS 3366 Dental base metal casting alloys Part 1 : 1988 Specification for denture base alloys EN 26873BS 7013 : 1989 Specification for dental gypsum products EN 26874BS EN 26874 : 1992 Specification for dental resin-based pit and fissure sealants EN 26876BS 6934 : 1
14、988 Specification for dental root canal sealing materials EN 27491BS 6790 : 1987 Method for determination of colour stability of dental polymeric materials EN 29333BS EN 29333 : 1992 Specification for dental brazing materials EN 29917BS EN 29917 : 1994 Specification for dental water-based cements EN
15、 30139-1 BS EN 30139 Dentistry Resilient lining materials for removable dentures Part 1 : 1994 Short-term materials EN 30993-1 BS EN 30993 Biological evaluation of medical devices Part 1 : 1994 Guidance on selection of tests EN 30993-3Part 3 : 1994 Test for genotoxicity, carcinogenicity and reproduc
16、tive toxicity EN 30993-4Part 4 : 1994 Selection of tests for interactions with blood EN 30993-5Part 5 : 1994 Tests for cytotoxicity, in vitro methods EN 30993-6Part 6 : 1995 Test for local effects after implantation EN 28601BS EN 28601 : 1992 Specification for representation of dates and times in in
17、formation interchange Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BSI 1997iii BS EN 1641 : 1997 Publication referred toCorresponding British Standard EN ISO 1562BS EN ISO 1562 : 1995 Dental casting gold alloys EN ISO 1567BS EN ISO 1567 :
18、 1995 Dentistry Denture base polymers EN ISO 1942-5 BS EN ISO 1942 Dental vocabulary Part 5 : 1995 Terms associated with testing EN ISO 3336BS EN ISO 3336 : 1996 Dentistry Synthetic polymer teeth EN ISO 4824BS EN ISO 4824 : 1997 Dentistry Ceramic denture teeth EN ISO 8891BS EN ISO 8891 : 1995 Dental
19、 casting alloys with noble metal content of 25% up to but not including 75% EN ISO 9693BS EN ISO 9693 : 1995 Specification for dental ceramic fused to metal restorative materials EN ISO 10477BS 7651 : 1993 Specification for dental polymer-based crown and bridge materials EN ISO 10993-10 BS EN ISO 10
20、993 Biological evaluation of medical devices Part 10 : 1996 Tests for irritation and sensitization 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
21、cover, an inside front cover, pages i to iv, the EN title page, pages 2 to 8, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ivblank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+
22、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 1996 Copyright reserved to CEN members Ref. No. EN 1641 : 1996 E EUROPEAN STANDARDEN 1641 NO
23、RME EUROPE ENNE EUROPA ISCHE NORM August 1996 ICS 11.060.10 Descriptors: Dentistry, dental material, specifications, information, labelling, technical notices English version Dentistry Medical devices for dentistry Materials Art dentaire Dispositifs pour lart dentaire Produits Zahnheilkunde Medizinp
24、rodukte fu r die Zahnheilkunde Werkstoffe This European Standard was approved by CEN on 1996-07-04. 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-
25、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 European Standard exists in three official versions (English, French, German). A version in any other language made by translation unde
26、r 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 national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherla
27、nds, 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) BSI Page 2 EN 1641 : 1996 BSI 1997 Foreword This standard has been prepared by Technical Committee CEN/TC 55, Dentistry, the Se
28、cretariat 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 and supports essential requirements of the EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, whi
29、ch 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 endorsement, at the latest by February 1997, and conflicting national standards shall be withdrawn at the latest by February 1997. Accord
30、ing to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
31、Switzerland, United Kingdom. There are three levels of European Standards dealing with medical devices used in dentistry. These are as follows. Level 1: General requirements for medical devices. Level 2: Particular requirements for families of medical devices used in dentistry. Level 3: Specific req
32、uirements 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 is a level 2 standard and details requirements that apply to those materials used in the practice of dentistry for the restorati
33、on of the form and function of the dentition (for dental implants see EN 1642). It also indicates 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 u
34、se a standard of the lowest available level. If a restorative material incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC 2, and whose action in combination with the device can result in
35、 its bioavailibility, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in Directive 75/318/EEC 3, as last amended by Directive 89/341/EEC 4. In the informative annex A a refer
36、ence for guidance on the classification of medical devices used in dentistry 5 is given. Contents Page Foreword2 1Scope3 2Normative references3 3Definitions4 4Requirements4 Annexes A(informative) Bibliography6 ZA(informative) Clauses of this European Standard addressing essential requirements or oth
37、er provisions of EU Directives7 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 1641 : 1996 BSI 1997 1 Scope This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration
38、of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative materials. Dental implants are specifically excluded and described in EN 1642. This standard includes requirements for intended performance, design at
39、tributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate. 2 Normative references This European Standard incorporates by dated or undat
40、ed reference provisions from other publications. These normative references 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 in
41、corporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 540Clinical investigation of medical devices for human subjects EN 980Graphical symbols for use in the labelling of medical devices prEN 1041Information supplied by the man
42、ufacturer with medical devices EN 1642Dentistry Medical devices for dentistry Dental implants EN 21942-1Dental vocabulary Part 1: General and clinical terms EN 21942-2Dental vocabulary Part 2: Dental materials EN 21559Dentistry Alloys for dental amalgam EN 21560Dentistry Dental mercury EN 21561Denta
43、l inlay casting wax EN 21563Dental alginate impression material EN 21564Dentistry Agar impression material EN 23107Dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements EN 24049Dentistry Resin-based filling materials EN 24823Dental elastomeric impression materials EN 26871Dentistry De
44、ntal base metal casting alloys EN 26873Dentistry Dental gypsum products EN 26874Dental resin-based pit and fissure sealants EN 26876Dentistry Dental root canal sealing materials EN 27491Dentistry Dental materials Determination of colour stability of dental polymeric materials EN 29333Dental brazing
45、materials EN 29917Dental water based cements EN 30139-1Dentistry Resilient lining materials for removable dentures Part 1: Short-term materials EN 30993-1Biological evaluation of medical devices Part 1: Guidance on selection of tests EN 30993-3Biological evaluation of medical devices Part 3: Test fo
46、r 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 devices Part 5: Tests for cytotoxicity In vitro methods EN 30993-6Biological evaluation of me
47、dical devices Part 6: Test for local effects after implantation EN 28601Data elements and interchange formats Information interchange Representation of dates and times EN ISO 1562Dentistry Dental casting gold alloys EN ISO 1567Dentistry Denture base polymers EN ISO 1942-5Dental vocabulary Part 5: Te
48、rms associated with testing EN ISO 3336Dentistry Synthetic polymer teeth EN ISO 4824Dentistry Ceramic denture teeth ISO 6872Dental ceramic prEN ISO 7405Biological evaluation of dental materials EN ISO 8891Dental casting alloys with noble metal content of 25% up to but not including 75% EN ISO 9693De
49、ntal ceramic fused to metal restorative materials EN ISO 10477Dentistry Polymer based crown and bridge materials Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:33 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1641 : 1996 BSI 1997 EN ISO 10993-10 Biological 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 t