BS EN ISO 10993-8:2001

1 Scope
2 Normative references
3 Terms and definitions
   3.1 Certified reference material
   3.2 Reference material
   3.3 Homogeneous
   3.4 Reference method
   3.5 Stability of property values
4 Use of certified reference materials or reference
   materials
5 Characteristics of reference materials
   5.1 One or more property values
   5.2 Long-term availability of the reference material
   5.3 Certification of reference materials for
       biological safety testing
6 Use of reference materials as experimental controls
   6.1 Material screening versus biocompatibility of
       medical devices
   6.2 Misuse of CRMs
Bibliography
Annex ZA (normative) Normative references to international
         publications with their relevant European
         publications

Gives requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. It gives the selection and qualification of reference materials for biological tests and the characteristics of reference materials for the use of reference manuals as experimental controls.