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BS EN ISO 20166-3:2019

BS EN ISO 20166-3:2019

Current

Current

The latest, up-to-date edition.

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Isolated DNA

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-28-2019

Publisher

British Standards Institution

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed.

This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination during the pre-examination phase before a molecular assay is performed.

This document is applicable to molecular invitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, invitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

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

Committee
CH/212
DocumentType
Standard
ISBN
9780580919251
Pages
26
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 20166-3:2018 Identical
EN ISO 20166-3:2019 Identical

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Hardcopy - English
PDF - English
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