Certified reference material / standard reference material

IVD manufacturers use certified reference materials to establish the traceability of calibrators and to show trueness. The certificate and its stated uncertainty belong in the evidence for analytical performance.

Reference material, accompanied by a certificate, one or more whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence.

MDCG 2022-2, Section 4, Definitions (source: WHO TGS-8)