1、BS EN 1641:2009ICS 11.060.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDDentistry Medicaldevices for dentistry MaterialsThis British Standardwas published underthe authority of theStandards Policy andStrategy Committee on 30November 2009 BSI 2009ISBN 978 0 5
2、80 63627 1Amendments/corrigenda issued since publicationDate CommentsBS EN 1641:2009National forewordThis British Standard is the UK implementation of EN 1641:2009. Itsupersedes BS EN 1641:2004 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/2, P
3、rosthodontic materials.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot
4、confer immunityfrom legal obligations.BS EN 1641:2009EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1641 October 2009 ICS 11.060.10 Supersedes EN 1641:2004English Version Dentistry - Medical devices for dentistry - Materials Art dentaire - Dispositifs mdicaux pour lart dentaire - Produits Zahn
5、heilkunde - Medizinprodukte fr die Zahnheilkunde - Werkstoffe This European Standard was approved by CEN on 19 September 2009. 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
6、without any alteration. Up-to-date lists 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 lang
7、uage 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 the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finla
8、nd, France, Germany, Greece, 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 KO
9、MITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1641:2009: EBS EN 1641:2009EN 1641:2009 (E) 2 Contents page Foreword 3Introduction . 41 Scope 52 Normative r
10、eferences 53 Terms and definitions . 64 Requirements . 74.1 General 74.2 Chemical and physical properties . 74.2.1 Composition . 74.2.2 Biocompatibility . 74.2.3 Material properties . 74.3 Control of contamination 74.4 Restorative materials used in combination 74.5 Clinical evaluation . 84.6 Marking
11、, 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 . 10Bibliography 11BS EN 1641:2009EN 1641:200
12、9 (E) 3 Foreword This document (EN 1641:2009) 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 text or by endorsement, at the latest
13、by April 2010, and conflicting national standards shall be withdrawn at the latest by April 2010. 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 responsible for identifying any or all such pat
14、ent rights. This document supersedes EN 1641:2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports the essential requirements of EU Directive 93/42/EEC. For the relationship with EU Directive 93/42/EEC, see
15、 informative annex ZA, which is an integral part of this document. The following changes were made: a) Addition of materials used in the practice of orthodontics; b) Normative references: 1) Addition of new relevant product standards, issued after 2004: EN ISO 3107, EN ISO 9333, EN ISO 9917-1, EN IS
16、O 10139-1, EN ISO 14971, EN ISO 15841, EN ISO 15854, EN ISO 21606, EN ISO 22112, EN ISO 22674, EN ISO 24234. 2) Deletion of the following withdrawn standards: EN 21560, EN 23107, EN 26874, EN 29333, EN 29917, EN 30139-1, EN ISO 1559, EN ISO 1561, EN ISO 1562, EN ISO 1567, EN ISO 3336, EN ISO 4824, E
17、N ISO 6871-1, EN ISO 8891, EN ISO 12163. c) 4.5 Clinical evaluation: Clarification of requirement for a clinical evaluation; d) 4.6.4 Instructions for use: Clarification of requirement that information may be provided in an electronic format; e) Annex ZA: Actualisation of correspondence between this
18、 European Standard and Directive 93/42/EEC, as amended by Directive 2007/47/EC. 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, Cyprus, Czech Republic, Denmar
19、k, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 1641:2009EN 1641:2009 (E) 4 Introduction There are three
20、levels 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
21、. There 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 those materials used in the practice of dentistry for the restoration of the form and function of the dentition (f
22、or dental implants see EN 1642) and those for the practice of orthodontics. 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 us
23、e a standard of the lowest available level. The manufacturer will need to consider whether: 1) The 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 2001/83/EEC 2, and whose action in co
24、mbination with the material can result in its bioavailability. Directive 2001/83/EEC specifies the appropriate methods for assessing the safety, quality and usefulness of that substance. 2) The material includes a constituent which may be classified as a hazardous substance according to the Dangerou
25、s Substances Directive 67/548/EEC 3, as amended by the Dangerous Preparations Directive 1999/45/EC 4. Attention is drawn to the labelling requirements of these Directives where the hazardous constituent content is above certain concentration limits. A reference for guidance on the classification of
26、dental devices and accessories is given in the Bibliography 6. BS EN 1641:2009EN 1641:2009 (E) 5 1 Scope This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices.
27、For the purposes of this standard these materials are defined as restorative and orthodontic materials. Dental implants are specifically excluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes req
28、uirements for intended performance, design attributes, 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 The foll
29、owing 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. EN 980, Symbols for use in the labelling of medical devic
30、es EN 1041, Information supplied by the manufacturer of medical devices EN 21563, Alginate dental impression material (ISO 1563:1990) EN 21942-1:1991, Dental vocabulary Part 1: General and clinical terms (ISO 1942-1:1989) EN 21942-2:1992, Dental vocabulary Part 2: Dental materials (ISO 1942-2:1989)
31、EN ISO 1564, Dental aqueous impression materials based on agar (ISO 1564:1995) EN ISO 1942-5:1994, Dental vocabulary Part 5: Terms associated with testing (ISO 1942-5:1989) EN ISO 3107, Dentistry Zinc oxide/eugenol and zinc oxide/non-eugenol cements (ISO 3107:2004) EN ISO 4049, Dentistry Polymer-bas
32、ed filling, restorative and luting materials (ISO 4049:2000) EN ISO 4823, Dentistry Elastomeric impression materials (ISO 4823:2000) EN ISO 6872, Dentistry Ceramic materials (ISO 6872:2008) EN ISO 6873, Dental gypsum products (ISO 6873:1998) EN ISO 6874, Dentistry Polymer-based pit and fissure seala
33、nts (ISO 6874:2005) EN ISO 6876, Dental root canal sealing materials (ISO 6876:2001) EN ISO 6877, Dentistry Root-canal obturating points (ISO 6877:2006) EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008) EN ISO 7491, Dental materials Determinat
34、ion of colour stability (ISO 7491:2000) EN ISO 7551, Dental absorbent points (ISO 7551:1996) EN ISO 9333, Dentistry Brazing materials (ISO 9333:2006) EN ISO 9693, Metal-ceramic dental restorative systems (ISO 9693:1999) EN ISO 9917-1, Dentistry Water-based cements Part 1: Powder/liquid acid-base cem
35、ents (ISO 9917-1:2007) BS EN 1641:2009EN 1641:2009 (E) 6 EN ISO 9917-2, Dental water-based cements Part 2: Light-activated cements (ISO 9917-2:1998) EN ISO 10139-1, Dentistry Soft lining materials for removable dentures Part 1: Materials for short-term use (ISO 10139-1:2005) EN ISO 10139-2, Dentistr
36、y Soft lining materials for removable dentures Part 2: Materials for long-term use (ISO 10139-2:1999) EN ISO 10271, Dental metallic materials Corrosion test methods (ISO 10271:2001) EN ISO 10477, Dentistry Polymer-based crown and bridge materials (ISO 10477:2004) EN ISO 10993-1, Biological evaluatio
37、n of medical devices Part 1: Evaluation and testing (ISO 10993-1:2003) EN ISO 13716, Dentistry Reversible-irreversible hydrocolloid impression material systems (ISO 13716:1999) EN ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements (ISO 14155-1:2003
38、) EN ISO 14155-2, Clinical investigations of medical devices for human subjects Part 2: Clinical investigation plans (ISO 14155-2:2003) EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2007) EN ISO 15841, Dentistry Wires for use in orthodontics (ISO 15841:20
39、06) EN ISO 15854, Dentistry Casting and baseplate waxes (ISO 15854:2005) EN ISO 20795-1, Dentistry Base polymers - Part 1: Denture base polymers (ISO 20795-1:2008) EN ISO 21606, Dentistry Elastomeric auxiliaries for use in orthodontics (ISO 21606:2007) EN ISO 22112, Dentistry Artificial teeth for de
40、ntal prostheses (ISO 22112:2005) EN ISO 22674, Dentistry Metallic materials for fixed and removable restorations and appliances (ISO 22674:2006) EN ISO 24234, Dentistry Mercury and alloys for dental amalgam (ISO 24234:2004) ISO 8601, Data elements and interchange formats Information interchange Repr
41、esentation of dates and times 3 Terms and definitions For the purposes of this European Standard, 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 restorative material material used in the restoration of the form and function of the
42、 teeth NOTE This includes, for example, impression and other materials used transiently in the mouth, denture teeth and denture base resins, casting alloys, filling and lining materials. 3.2 orthodontic material material used in orthodontics NOTE This includes, for example, orthodontic wires and ela
43、stomeric auxiliaries. BS EN 1641:2009EN 1641:2009 (E) 7 4 Requirements 4.1 General 4.1.1 Restorative and orthodontic materials shall comply with the requirements which are applicable to them bearing in mind the intended purpose of the device concerned. Conformity with these requirements shall be con
44、sidered 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 EN ISO 14971. 4.2 Chemical and physical properties 4.2.1 Composition Resto
45、rative and orthodontic materials shall satisfy the compositional requirements as specified in the following standards, if appropriate: EN ISO 20795-1, EN ISO 3107, EN ISO 6872, EN ISO 9333, EN ISO 9693, EN ISO 9917-1, EN ISO 9917-2, EN ISO 15841, EN ISO 22112, EN ISO 22674, EN ISO 24234. 4.2.2 Bioco
46、mpatibility Restorative and orthodontic materials 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 restorative materials. Special attention shall be given to substances which are carcin
47、ogenic, mutagenic or toxic to reproduction. NOTE Further information is given in Annex I of Council Directive 67/548/EEC of 27 June 1967. 4.2.3 Material properties The chemical and physical properties of restorative and orthodontic materials shall be determined in accordance with the test methods as
48、 specified in the following standards, if appropriate: EN 21563, EN ISO 1564, EN ISO 20795-1, EN ISO 3107, EN ISO 4049, EN ISO 4823, EN ISO 6872, EN ISO 6873, EN ISO 6874, EN ISO 6876, EN ISO 6877, EN ISO 7491, EN ISO 7551, EN ISO 9333, EN ISO 9693, EN ISO 9917-1, EN ISO 9917-2, EN ISO 10139-1, EN I
49、SO 10139-2, EN ISO 10271, EN ISO 10477, EN ISO 12163, EN ISO 13716, EN ISO 15841, EN ISO 15854, EN ISO 21606, EN ISO 22112, EN ISO 22674, EN ISO 24234. 4.3 Control of contamination 4.3.1 Restorative and orthodontic materials shall be designed and manufactured under conditions to minimize microbial or other contamination, if appropriate. 4.3.2 Packaging systems for restorative and orthodontic materials supplied non-steri
