Examens moléculaires de diagnostic in vitro — Spécifications pour les procédés de préexamen des tissus fixés au formol et inclus en paraffine (FFPE) — Partie 4: Techniques de détection in situ
Numéro de référence:
CSA ISO 20166-4
Catégorie de norme:
Norme nationale du Canada - Adoption d'une Norme internationale
Type d’activité d’élaboration de normes:
Nouvelle norme
Code ICS:
11.100.10
Statut:
En cours d'élaboration
Date de début de la période de commentaires OEN:
Date de fin de la période de commentaires des OEN:
Affiché le:
Porté:
Champ d’application
ISO Number
Proposed Adoption
ISO ED
— Specifications for pre-examination
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 1: Isolated
RNA 1 1 NS,
F, E This document gives guidelines on
the handling, documentation, storage
and processing of formalin-fixed and
paraffin-embedded (FFPE) tissue
specimens intended for RNA
examination during the preexamination
phase before a
molecular assay is performed. 20166-2:2018 Molecular in vitro diagnostic examinations
— Specifications for pre-examinations
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 2: Isolated
proteins 1 1 NS,
F, E This document gives guidelines on
the handling, documentation, storage
and processing of formalinfixed
and paraffin-embedded (FFPE)
tissue specimens intended for the
examination of isolated proteins
during the pre-examination phase
before a molecular assay is
performed. 20166-3:2018 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 3: Isolated
DNA 1 1 NS,
F, E This document gives guidelines on
the handling, documentation, storage
and processing of formalinfixed
and paraffin-embedded (FFPE)
tissue specimens intended for DNA
examination during the preexamination
phase before a
molecular assay is performed. 20166-4:2021 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 4: In situ
detection techniques 1 1 NS,
F, E This document specifies
requirements and gives
recommendations for the collection,
handling, documentation, transport,
storage and processing during the
pre-examination phase of formalinfixed
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 20186-1:2019 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for venous whole blood — Part
1: Isolated cellular RNA 1 1 NS,
F, E This document gives guidelines on
the handling, storage, processing and
documentation of venous
whole blood specimens intended for
cellular RNA examination during the
pre-examination phase
5
before a molecular examination is
performed. This document covers
specimens collected in venous
whole blood collection tubes. 20186-2:2019 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for venous whole blood — Part
2: Isolated genomic DNA, 1 1 NS,
F, E This document gives guidelines on
the handling, storage, processing and
documentation of venous
whole blood specimens intended for
genomic DNA examination during the
pre-examination phase
before a molecular examination is
performed. This document covers
specimens collected in venous
whole blood collection tubes. 20186-3:2019 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for venous whole blood — Part
3: Isolated circulating cell-free DNA from
plasma 1 1 NS,
F, E This document provides
recommendations and requirements
on the handling, storage, processing
and documentation of venous whole
blood specimens intended for
circulating cell free DNA (ccfDNA)
examination during the preexamination
phase before an
analytical test is performed. This
document
covers specimens collected in venous
whole blood collection tubes.
CSA ED
Type Scope 20166-1:2018 Molecular in vitro diagnostic examinations— Specifications for pre-examination
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 1: Isolated
RNA 1 1 NS,
F, E This document gives guidelines on
the handling, documentation, storage
and processing of formalin-fixed and
paraffin-embedded (FFPE) tissue
specimens intended for RNA
examination during the preexamination
phase before a
molecular assay is performed. 20166-2:2018 Molecular in vitro diagnostic examinations
— Specifications for pre-examinations
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 2: Isolated
proteins 1 1 NS,
F, E This document gives guidelines on
the handling, documentation, storage
and processing of formalinfixed
and paraffin-embedded (FFPE)
tissue specimens intended for the
examination of isolated proteins
during the pre-examination phase
before a molecular assay is
performed. 20166-3:2018 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 3: Isolated
DNA 1 1 NS,
F, E This document gives guidelines on
the handling, documentation, storage
and processing of formalinfixed
and paraffin-embedded (FFPE)
tissue specimens intended for DNA
examination during the preexamination
phase before a
molecular assay is performed. 20166-4:2021 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for formalin-fixed and paraffinembedded
(FFPE) tissue — Part 4: In situ
detection techniques 1 1 NS,
F, E This document specifies
requirements and gives
recommendations for the collection,
handling, documentation, transport,
storage and processing during the
pre-examination phase of formalinfixed
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 20186-1:2019 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for venous whole blood — Part
1: Isolated cellular RNA 1 1 NS,
F, E This document gives guidelines on
the handling, storage, processing and
documentation of venous
whole blood specimens intended for
cellular RNA examination during the
pre-examination phase
5
before a molecular examination is
performed. This document covers
specimens collected in venous
whole blood collection tubes. 20186-2:2019 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for venous whole blood — Part
2: Isolated genomic DNA, 1 1 NS,
F, E This document gives guidelines on
the handling, storage, processing and
documentation of venous
whole blood specimens intended for
genomic DNA examination during the
pre-examination phase
before a molecular examination is
performed. This document covers
specimens collected in venous
whole blood collection tubes. 20186-3:2019 Molecular in vitro diagnostic examinations
— Specifications for pre-examination
processes for venous whole blood — Part
3: Isolated circulating cell-free DNA from
plasma 1 1 NS,
F, E This document provides
recommendations and requirements
on the handling, storage, processing
and documentation of venous whole
blood specimens intended for
circulating cell free DNA (ccfDNA)
examination during the preexamination
phase before an
analytical test is performed. This
document
covers specimens collected in venous
whole blood collection tubes.
Raison d’être du projet
Raison d’être du projet
To align Canadian requirements with those of international standards (adoption of new standards). The proposed New Standards are being developed at the request of Medical Laboratory Quality Systems
Technical Committee(Z252) under the jurisdiction of the Strategic Steering Committee on Health and Wellbeing. It will provide industry with consistent requirements for the entire molecular in vitro diagnostics workflow (specimen collection to RNA examination).
Note : L’information ci-dessus a été recueillie et est diffusée par le Conseil canadien des normes (CCN) pour les besoins de son système de notification centralisé et transparent pour l’élaboration de nouvelles normes. Le système permet aux organismes d’élaboration de normes (OEN) accrédités par le CCN et aux membres du public d’être informés des nouveaux travaux d’élaboration de normes au Canada. Il donne aussi aux OEN accrédités la possibilité de repérer et de résoudre les cas de doubles emplois éventuels dans les normes et les travaux de normalisation.
Les OEN sont eux-mêmes responsables du contenu et de l’exactitude de l’information présentée ici. Cette information n’existe que dans la langue dans laquelle elle a été fournie au CCN.