Dentistry – Medical devices for dentistry – Dental implants
DIN EN 1642:2012-06 (E)
Dentistry – Medical devices for dentistry – Dental implants
Contents Page
page Foreword ………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 6
4 Requirements ………………………………………………………………………………………………………………… 6
4.1 General ………………………………………………………………………………………………………………………….. 6
4.2 Design and properties ……………………………………………………………………………………………………. 6
4.2.1 Materials ………………………………………………………………………………………………………………………… 6
4.2.2 Contents of technical file ……………………………………………………………………………………………….. 6
4.2.3 Biocompatibility …………………………………………………………………………………………………………….. 6
4.2.4 Biophysical properties and modelling …………………………………………………………………………….. 6
4.3 Control of contamination ……………………………………………………………………………………………….. 7
4.3.1 General ………………………………………………………………………………………………………………………….. 7
4.3.2 Dental implants supplied sterile ……………………………………………………………………………………… 7
4.3.3 Dental implants supplied non-sterile ………………………………………………………………………………. 7
4.3.4 Dental implants which incorporate materials of animal origin …………………………………………. 7
4.4 Dental implants used in combination ……………………………………………………………………………… 7
4.5 Clinical investigation and evaluation ………………………………………………………………………………. 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 Label ……………………………………………………………………………………………………………………………… 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