Criteria for the Certification of Internationally Acceptable Reference Materials.

Abstract

On 31.10.96 a collaboration agreement was signed between IRMM and IFCC for the production , certification and distribution of clinical reference materials. These reference materials will be produced according to internationally agreed criteria as laid down in the BRC Guidelines, so that they can be certified as BCR CRMs. This implies that not only particular care is devoted to the preparation, conditioning of the candidate CRM, but also that the certification is traceable to the international system of units, to described or accepted standardised procedures or to internationally accepted primary materials. Moreover, homogeneity and stability studies must provide evidence of identity between samples and of absence of deterioration upon storage or during transport.