NEN EN 1642 : 2011
Current
The latest, up-to-date edition.
DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - DENTAL IMPLANTS
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General
4.2 Design and properties
4.3 Control of contamination
4.3.1 General
4.3.2 Dental implants supplied sterile
4.3.3 Dental implants supplied non-sterile
4.3.4 Dental implants which incorporate materials of
animal origin
4.4 Dental implants 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
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