Dentistry – Medical devices for dentistry – Instruments
DIN EN 1639:2010-02 (E)
Dentistry – Medical devices for dentistry – Instruments
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..7
4 Requirements …………………………………………………………………………………………………………………8
4.1 General …………………………………………………………………………………………………………………………..8
4.2 Chemical and physical properties ……………………………………………………………………………………8
4.2.1 General …………………………………………………………………………………………………………………………..8
4.2.2 Contaminants and residues …………………………………………………………………………………………….8
4.2.3 Contact with substances …………………………………………………………………………………………………9
4.3 Control of contamination ………………………………………………………………………………………………..9
4.3.1 General …………………………………………………………………………………………………………………………..9
4.3.2 Instruments supplied sterile ……………………………………………………………………………………………9
4.3.3 Instruments supplied non-sterile …………………………………………………………………………………….9
4.4 Construction and environmental properties …………………………………………………………………….9
4.5 Instruments connected to or equipped with an energy source ……………………………………….10
4.6 Protection against electrical risks ………………………………………………………………………………….10
4.7 Protection against mechanical and thermal risks …………………………………………………………..10
4.7.1 Vibration ……………………………………………………………………………………………………………………….10
4.7.2 Noise …………………………………………………………………………………………………………………………….10
4.7.3 Electricity, gas or hydraulic and pneumatic energy ………………………………………………………..10
4.7.4 Surface temperature ……………………………………………………………………………………………………..10
4.8 Controls and indicators …………………………………………………………………………………………………11
4.9 Clinical evaluation …………………………………………………………………………………………………………11
4.10 Marking, labelling and information supplied by the manufacturer …………………………………..11
4.10.1 General …………………………………………………………………………………………………………………………11
4.10.2 Symbols ……………………………………………………………………………………………………………………….11
4.10.3 Marking …………………………………………………………………………………………………………………………11
4.10.4 Label …………………………………………………………………………………………………………………………….12
4.10.5 Detachable components ………………………………………………………………………………………………..12
4.10.6 Instructions for use ……………………………………………………………………………………………………….12
of EU Directive 93/42/EEC ……………………………………………………………………………………………………………..14
Bibliography …………………………………………………………………………………………………………………………………15