S.R. CEN/TS 16826-3:2018
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for snap frozen tissue – Part 3: Isolated DNA
Hardcopy , PDF
29-06-2021
English
13-08-2018
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.
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