This part of ISO 10993 specifies requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. It specifies the selection and qualification of reference materials for biological tests and the characteristics of reference materials for the use of reference materials as experimental controls.
BS EN ISO 10993-8:2001 history
2001BS EN ISO 10993-8:2001 Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests