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CEN/TS 16826-3

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA

active, Most Current
Organization: CEN
Publication Date: 1 July 2018
Status: active
Page Count: 20
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

This document 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 examination 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.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Document History

CEN/TS 16826-3
July 1, 2018
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA
This document 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...

References

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