Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 1: Isolated RNA

CSA Group
Standards Development Organisation:
Canadian Standards Association (operating as CSA Group)
Working Program:
View the CSA work program
Designation Number:
CSA ISO 20166-1
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:

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 pre-examination phase before a molecular assay is performed.

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.

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