DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS

Available format(s)

Hardcopy

Published date

01-03-2010

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 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

This European Standard specifies general requirements for instruments 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
UNE-EN 1639:2010	Identical
EN 1639:2009	Identical
NEN EN 1639 : 2009	Identical
NS EN 1639 : 2009	Identical
I.S. EN 1639:2009	Identical
NF EN 1639 : 2009	Identical
DIN EN 1639:2010-02	Identical
NBN EN 1639 : 2009	Identical
UNI EN 1639 : 2010	Identical
BS EN 1639:2009	Identical