NS EN 1641 : 2009
Current
The latest, up-to-date edition.
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - MATERIALS
01-12-2013
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.
| DocumentType |
Standard
|
| PublisherName |
Norwegian Standards (Norges Standardiseringsforbund)
|
| Status |
Current
|
| Standards | Relationship |
| UNE-EN 1641:2010 | Identical |
| I.S. EN 1641:2009 | Identical |
| EN 1641:2009 | Identical |
| DIN EN 1641:2010-02 | Identical |
| BS EN 1641:2004 | Identical |
| UNI EN 1641 : 2010 | Identical |
| SN EN 1641 : 2010 | Identical |
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