• SN EN 1640 : 2010

    Current The latest, up-to-date edition.

    DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT

    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 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

    Abstract - (Show below) - (Hide below)

    This European Standard specifies general requirements for dental equipment 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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