Dentistry – Medical devices for dentistry – Equipment
DIN EN 1640:2010-02 (E)
Dentistry – Medical devices for dentistry – Equipment
Contents 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 Chemical and physical properties ……………………………………………………………………………………6
4.2.1 Materials …………………………………………………………………………………………………………………………6
4.2.2 Contaminants and residues …………………………………………………………………………………………….7
4.2.3 Contact with substances …………………………………………………………………………………………………7
4.2.4 Ingress and leaking of substances ………………………………………………………………………………….7
4.3 Control of contamination ………………………………………………………………………………………………..7
4.4 Construction and environmental properties …………………………………………………………………….7
4.5 Protection against radiation …………………………………………………………………………………………….7
4.6 Equipment connected to or equipped with an energy source …………………………………………..8
4.7 Programmable electronic subsystems (software programmes) ………………………………………..8
4.8 Protection against electrical risks ……………………………………………………………………………………8
4.9 Protection against mechanical and thermal risks …………………………………………………………….8
4.9.1 Mechanical stability ………………………………………………………………………………………………………..8
4.9.2 Vibration …………………………………………………………………………………………………………………………8
4.9.3 Noise ………………………………………………………………………………………………………………………………8
4.9.4 Electricity, gas, hydraulic and pneumatic energy …………………………………………………………….8
4.9.5 Surface temperature ……………………………………………………………………………………………………….9
4.10 Controls and indicators …………………………………………………………………………………………………..9
4.11 Clinical evaluation …………………………………………………………………………………………………………..9
4.12 Marking, labelling and information supplied by the manufacturer …………………………………….9
4.12.1 General …………………………………………………………………………………………………………………………..9
4.12.2 Symbols …………………………………………………………………………………………………………………………9
4.12.3 Marking …………………………………………………………………………………………………………………………..9
4.12.4 Label …………………………………………………………………………………………………………………………….10
4.12.5 Detachable components ………………………………………………………………………………………………..10
4.12.6 Instructions for use ……………………………………………………………………………………………………….10
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ……………………………………………………………………….11
Bibliography …………………………………………………………………………………………………………………………………12