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Standard

NS-EN 14136:2004

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Abstract

This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: - scheme design and organization; - identification of procedures (IVD MDs) used by the participant; - classification and evaluation of data.

Document information

  • Standard from SN
  • Published:
  • Edition: 1
  • 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

  • Adopted from: EN 14136:2004 , 0