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Standard

NS-EN 1639:1996

Withdrawn

Note: This standard has a new edition: 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 design attributes, components, sterilization, packaging, marking, supplied by the manufacturer, for intended performance, labelling, and information. This standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by the level 2 and level 3 standards, for dental equipment. Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 1
  • Version: 1
  • Document type: NAT
  • ICS 11.060.20
  • ICS 11.060.25
  • National Committee CEN/TC 55/WG 7

Legal references

EU law: 93/42/EEC

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