• SN EN 1639:2010

    Current The latest, up-to-date edition.

    DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS

    Available format(s):  Hardcopy

    Language(s): 

    Published date:  01-03-2010

    Publisher:  Swiss Standards

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

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    Committee INB/NK 155
    Document Type Standard
    Publisher Swiss Standards
    Status Current
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