Standard

NS-EN 591:2001

Withdrawn

Corrigendums and amendments are bought separately.

Language
Services

Abstract

This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments. NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments. NOTE 2 This standard can also be applied to accessories. This standard is not applicable to field repair instructions.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2
  • Version: 1
  • Document type: NAT
  • ICS 11.100
  • ICS 11.100.10
  • National Committee SN/K 116

Legal references

EU law: 98/79/EC

Product Relations

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