Standard

NS-EN 1639:2009

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Abstract

This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer. This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640. Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.

Document information

  • Standard from SN
  • Published:
  • Edition: 2009-10
  • Version: 1
  • Document type: NAT
  • ICS 11.060.25
  • National Committee SN/K 109

Legal references

EU law: 93/42/EEC

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