NEN EN 1639 : 2009

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
  4.1 General
  4.2 Chemical and physical properties
      4.2.1 General
      4.2.2 Contaminants and residues
      4.2.3 Contact with substances
  4.3 Control of contamination
      4.3.1 General
      4.3.2 Instruments supplied sterile
      4.3.3 Instruments supplied non-sterile
  4.4 Construction and environmental properties
  4.5 Instruments connected to or equipped with an energy source
  4.6 Protection against electrical risks
  4.7 Protection against mechanical and thermal risks
      4.7.1 Vibration
      4.7.2 Noise
      4.7.3 Electricity, gas or hydraulic and pneumatic energy
      4.7.4 Surface temperature
  4.8 Controls and indicators
  4.9 Marking, labelling and information supplied by the manufacturer
      4.9.1 General
      4.9.2 Symbols
      4.9.3 Marking
      4.9.4 Labelling
      4.9.5 Detachable components
      4.9.6 Instructions for use
Annex ZA (informative) Relationship between this European Standard
         and the Essential Requirements of EU Directive 93/42/EEC
Bibliography

Defines general requirements for instruments used in the practice of dentistry and which are medical devices. It also includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer.