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Annex II REFERENCE MATERIAL

United Kingdom

Original text. Later amendments are not shown.

The reference material as referred to in Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003 shall be produced in accordance with internationally accepted technical provisions such as ISO Guides 30 to 34 (and more particularly ISO Guide 34, specifying the general requirements for the competence of reference material producers). The reference material shall be preferably certified and, if such is the case, certification shall be done in accordance with ISO Guide 35.

For verification and value assignment, a method that has been properly validated (see ISO/IEC 17025:5.4.5) shall be used. Uncertainties have to be estimated according to GUM (ISO Guide to the Expression of Uncertainty in Measurement: GUM). Major characteristics of these internationally accepted technical provisions are given below.

  1. ATerminology:
  2. BGM RM containers:
  3. CHomogeneity testing:
  4. DStability testing:
  5. EBatch characterisation:
  6. FFinal storage:
  7. GEstablishment of a certificate for CRMs: