BS EN ISO 20184-3:2021 - TC

This standard BS EN ISO 20184-3:2021 - TC Tracked Changes. Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for frozen tissue is classified in these ICS categories:

• 11.100.10 In vitro diagnostic test systems

This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.