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

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

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

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