NEN EN 1640 : 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 Materials
      4.2.2 Contaminants and residues
      4.2.3 Contact with substances
      4.2.4 Ingress and leaking of substances
  4.3 Control of contamination
  4.4 Construction and environmental properties
  4.5 Protection against radiation
  4.6 Equipment connected to or equipped with an energy
      source
  4.7 Protection against electrical risks
  4.8 Protection against mechanical and thermal risks
      4.8.1 Mechanical stability
      4.8.2 Vibration
      4.8.3 Noise
      4.8.4 Electricity, gas, hydraulic and pneumatic
            energy
      4.8.5 Surface temperature
  4.9 Controls and indicators
 4.10 Marking, labelling and information supplied by the
      manufacturer
      4.10.1 General
      4.10.2 Symbols
      4.10.3 Marking
      4.10.4 Labelling
      4.10.5 Detachable components
      4.10.6 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 dental equipment used in the practice of dentistry and which are medical devices. It also includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.