Full Description

This is the first edition of CSA Z316.8, Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions.

This Standard specifies the minimum requirements and best practices for the development, validation, and use of laboratory-developed tests in clinical and research laboratories for the screening, diagnosis, and management of clinical conditions.

It does not provide specific details on how to achieve these requirements since they are provided in many other sources which are considered current best practice. References to these resources will be provided in this Standard.

Product Details

Edition: 1st Published: 04/01/2018 ISBN(s): 9781488313660 Number of Pages: 33 File Size: 1 file , 670 KB Product Code(s): 2426061, 2426364, 2426061 Note: This product is unavailable in Russia, Ukraine, Belarus