This document aims to assist in designing and organizing trials for validation of biotests. The validation activities during the different steps of the standardization process are described. This document comprises the overall data evaluation and subsequent validation study conclusion.
This document is intended for the validation of biotests which can differ in their experimental design and endpoints. It is possible that some of the requirements of this document are not applicable to all test methods.
Status: PublishedPublication date: 2022-11
Edition: 1Number of pages: 43
Technical Committee: ISO/TC 190/SC 4 Biological characterization
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