NBN EN 1641 : 2009

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

Describes 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.