DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS

Available format(s)

Hardcopy

Published date

03-01-2010

Publisher

Swiss Standards

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Chemical and physical properties
      4.2.1 Composition
      4.2.2 Biocompatibility
      4.2.3 Material properties
  4.3 Control of contamination
  4.4 Restorative materials used in combination
  4.5 Clinical investigation
  4.6 Marking, labelling and information supplied by the
      manufacturer
      4.6.1 General
      4.6.2 Symbols
      4.6.3 Labelling
      4.6.4 Instructions for use
Annex ZA (informative) Relationship between this European
                       Standard and the Essential Requirements
                       of EU Directive 93/42/EEC
Bibliography

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.

Committee	INB/NK 155
DocumentType	Standard
Pages	0
PublisherName	Swiss Standards
Status	Current

Standards	Relationship
UNE-EN 1641:2010	Identical
NF EN 1641 : 2009	Identical
DIN EN 1641:2010-02	Identical
UNI EN 1641 : 2010	Identical
NBN EN 1641 : 2009	Identical
EN 1641:2009	Identical
BS EN 1641:2004	Identical
NEN EN 1641 : 2009	Identical
I.S. EN 1641:2009	Identical
NS EN 1641 : 2009	Identical