DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT

Available format(s)

Hardcopy

Published date

03-01-2010

Publisher

Swiss Standards

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

This European Standard specifies general requirements for dental equipment used in the practice of dentistry and which are medical devices.

Committee	INB/NK 155
DocumentType	Standard
Pages	0
PublisherName	Swiss Standards
Status	Current

Standards	Relationship
I.S. EN 1640:2009	Identical
DIN EN 1640:2010-02	Identical
NBN EN 1640 : 2009	Identical
EN 1640:2009	Identical
NS EN 1640 : 2009	Identical
NEN EN 1640 : 2009	Identical
BS EN 1640:2009	Identical
UNI EN 1640 : 2010	Identical
UNE-EN 1640:2010	Identical
NF EN 1640 : 2009	Identical