• NBN EN 1639 : 2009

    Current The latest, up-to-date edition.

    DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - INSTRUMENTS

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    Language(s): 

    Published date:  12-01-2013

    Publisher:  Belgian 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)

    Describes general requirements for instruments used in the practice of dentistry and which are medical devices.

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    Document Type Standard
    Publisher Belgian Standards
    Status Current
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