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I.S. EN ISO 20166-4:2021

Current

Current

The latest, up-to-date edition.

Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffinembedded (FFPE) tissue - Part 4: In situ detection techniques (ISO 20166-4:2021)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

15-08-2021

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Activities outside the laboratory
6 Activities inside the laboratory
Annex A (informative) Recommendations relating to verification and validation of laboratory developed in situ detection tests
Annex B (informative) Example protocol for tissue processing
Bibliography

This document specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques.

Committee
ISO/TC 212
DocumentType
Standard
Pages
44
ProductNote
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
ISO 20166-4:2021 Identical
EN ISO 20166-4:2021 Identical

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