Dentistry – Medical devices for dentistry – Materials
DIN EN 1641:2010-02 (E)
Dentistry – Medical devices for dentistry – Materials
Contents Page
age Foreword …………………………………………………………………………………………………………………………………3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Requirements …………………………………………………………………………………………………………………7
4.1 General …………………………………………………………………………………………………………………………..7
4.2 Chemical and physical properties ……………………………………………………………………………………7
4.2.1 Composition …………………………………………………………………………………………………………………..7
4.2.2 Biocompatibility ……………………………………………………………………………………………………………..7
4.2.3 Material properties ………………………………………………………………………………………………………….7
4.3 Control of contamination ………………………………………………………………………………………………..7
4.4 Restorative materials used in combination ………………………………………………………………………7
4.5 Clinical evaluation …………………………………………………………………………………………………………..8
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