
Biological evaluation of medical devices Selection and qualification of reference materials for biological tests
出版:Standards Australia

专家解读视频
Specifies requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. This Standard also 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.
ISO 10993-8:2000 - Identical