Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 3: Isolated DNA
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Standards Development Organisation:
Contact Information:
Working Program:
Designation Number:
CSA ISO 20166-3
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Standard
ICS code(s):
11.100.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:
Scope:
Scope
ISO Number
Proposed Adoption
ISO
ED 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.
ED 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.
Project need:
Project Need
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: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.
Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.