EN 1641:2004
(Main)Dentistry - Medical devices for dentistry - Materials
Dentistry - Medical devices for dentistry - Materials
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. 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 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.
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Werkstoffe
Diese Europäische Norm legt allgemeine Anforderungen an die Werkstoffe fest, die in der Zahn-, Mund- und Kieferheilkunde für die Wiederherstellung der Form und Funktion der Zähne verwendet werden und die Medi-zinprodukte sind. Für die Anwendung dieser Norm werden diese Werkstoffe als restaurative Werkstoffe bezeichnet. Dentalimplantate sind ausdrücklich ausgeschlossen und werden in EN 1642 beschrieben. Diese Norm legt Anforderungen an die geplante Leistung, die Konstruktionsmerkmale, die Bestandteile, die Sterilisation, die Verpackung, die Kennzeichnung, die Etikettierung und an die Informationen durch den Hersteller fest.
Für Prüfungen, die die Konformität mit dieser Norm nachweisen, gelten die entsprechenden Normen der Ebene 3, falls anwendbar
Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
La présente Norme européenne établit les exigences générales relatives aux produits utilisés dans la pratique de l'art dentaire pour la restauration morphologique et fonctionnelle de la denture et qui sont des dispositifs médicaux. Pour les besoins de cette norme, ces produits sont définis comme des produits de restauration. Les implants dentaires sont exclus du domaine d'application de cette norme et décrits dans l'EN 1642. Cette norme comporte également les exigences relatives à la performance attendue, aux caractéristiques de conception, aux composants, à la stérilisation, à l'emballage, au marquage, à l'étiquetage ainsi qu'aux informations fournies par le fabricant.
Les essais prouvant la conformité à la présente norme sont décrits, le cas échéant, dans les normes de niveau 3.
Zobozdravstvo - Medicinski pripomočki za zobozdravstvo - Materiali
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2005
1DGRPHãþD
SIST EN 1641:2000
=RER]GUDYVWYR0HGLFLQVNLSULSRPRþNL]D]RER]GUDYVWYR0DWHULDOL
Dentistry - Medical devices for dentistry - Materials
Zahnheilkunde - Medizinprodukte für die Zahnheilkunde - Werkstoffe
Art dentaire - Dispositifs médicaux pour l'art dentaire - Produits
Ta slovenski standard je istoveten z: EN 1641:2004
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 1641
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2004
ICS 11.060.10 Supersedes EN 1641:1996
English version
Dentistry - Medical devices for dentistry - Materials
Art dentaire - Dispositifs médicaux pour l'art dentaire - Zahnheilkunde - Medizinprodukte für die Zahnheilkunde -
Produits Werkstoffe
This European Standard was approved by CEN on 17 March 2004.
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-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
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 national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1641:2004: E
worldwide for CEN national Members.
Contents
page
Foreword.3
1 Scope.5
2 Normative references.5
3 Terms and definitions .6
4 Requirements.7
4.1 General.7
4.2 Chemical and physical properties .7
4.2.1 Composition.7
4.2.2 Biocompatibility.7
4.2.3 Material properties.7
4.3 Control of contamination .7
4.4 Restorative materials used in combination .7
4.5 Clinical investigation.7
4.6 Marking, labelling and information supplied by the manufacturer .8
4.6.1 General.8
4.6.2 Symbols.8
4.6.3 Labelling.8
4.6.4 Instructions for use .8
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC.10
Bibliography .11
Foreword
This document (EN 1641:2004) 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 by December 2004, and conflicting national standards shall be withdrawn at the latest
by December 2004.
This document supersedes EN 1641:1996.
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 with EU Directive 93/42/EEC, see informative annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Introduction
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 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 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 (for dental implants see EN 1642). 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.
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
combination 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
Dangerous 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.
In the Bibliography a reference for guidance on the classification of dental devices and accessories [5] is given.
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. 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 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
This European Standard incorporates by dated or undated 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 incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
EN 980, Graphical symbols for use in the labelling of medical devices.
EN 1041, Information supplied by the manufacturer with medical devices.
EN 21560, Dentistry — Dental mercury.
EN 21563, Alginate dental impression material (ISO 1563:1990).
EN 21942-1, Dental vocabulary — Part 1: General and clinical terms.
EN 21942-2, Dental vocabulary — Part 2: Dental materials (ISO 1942-2:1989).
EN 23107, Dental zinc oxide/eugenol cements and zinc oxide non-eugenol cements (ISO 3107:1988).
EN 26874, Dental resin-based pit and fissure sealants (ISO 6874:1988).
EN 28601, Data elements and interchange formats — Information interchange — Representation of dates and
times (ISO 8601:1988 and its technical corrigendum 1:1991).
EN 29333, Dental brazing materials (ISO 9333:1990).
EN 30139-1, Dentistry — Resilient lining materials removable dentures — Part 1: Short-term materials (ISO 10139-
1:1991).
EN ISO 1559, Dental materials - Alloys for dental amalgam (ISO 1559:1995 + Technical Corrigendum 1:1997)
EN ISO 1561, Dental casting wax (ISO 1561:1995).
EN ISO 1562, Dental casting gold alloys (ISO 1562:1993).
EN ISO 1564, Dental aqueous impression materials based on agar (ISO 1564:1995).
EN ISO 1567, Dentistry — Denture base polymers (ISO 1567:1999).
EN ISO 1942-5, Dental vocabulary — Part 5: Terms associated with testing (ISO 1942-5:1989).
EN ISO 3336, Dentistry — Synthetic polymer teeth (ISO 3336:1993).
EN ISO 4049, Dentistry — Polymer-based filling, restorative and luting materials (ISO 4049:2000).
EN ISO 4823, Dentistry — Elastomeric impression materials (ISO 4823:2000)
EN ISO 4824, Dentistry — Ceramic denture teeth (ISO 4824:1993).
EN ISO 6871-1, Dental base metal casting alloys — Part 1: Cobalt-based alloys (ISO 6871-1:1994).
EN ISO 6872, Dental ceramic (ISO 6872:1995).
EN ISO 6873, Dental gypsum products (ISO 6873:1998).
EN ISO 6876, Dental root canal sealing materials (ISO 6876:2001)
EN ISO 6877, Dental root-canal obturating points (ISO 6877:1995).
EN ISO 7405, Dentistry — Preclinical evaluation of biocompatibility of medical devices used in dentistry — Test
methods for dental materials (ISO 7405:1997).
EN ISO 7491, Dental materials — Determination of colour stability (ISO 7491:2000).
EN ISO 7551, Dental absorbent points (ISO 7551:1996).
EN ISO 8891, Dental casting alloys with noble metal content of at least 25 % but less than 75 % (ISO 8891:1998).
EN ISO 9693, Metal-ceramic dental restorative systems (ISO 9693:1999).
EN ISO 9917-2, Dental water-based cements — Part 2: Light activated cements (ISO 9917-2:1998).
EN ISO 10139-2, Dentistry — 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 10477:1992).
EN ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003).
EN ISO 12163, Dental baseplate/modelling wax (ISO 12163:1999).
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).
EN ISO 14155-2, Clinical investigations of medical devices for human subjects — Part 2: Clinical investigation
plans (ISO 14155-2:2003).
3 Terms and definitions
For the purposes of this European Standard, the terms and definitions given in EN 21942-1, EN 21942-2, EN ISO
1942-5 and the following apply.
3.1
restorative material
material used in restorative dentistry including, for example, impression and other materials used transiently in the
mouth, denture teeth and denture base resins, casting alloys, filling and lining materials
4 Requirements
4.1 General
4.1.1 Restorative 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 considered to be met by
demonstrating compliance with the requirements of the following subclauses, if appropriate.
4.1.2 A risk analysis shall be carried out and documented.
NOTE EN ISO 14971 [6] describes the procedures to be carried out.
4.2 Chemical and physical properties
4.2.1 Composition
Restorative materials shall satisfy the
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