CAN/CSA-ISO 20166-1:22 PDF

CSA Preface 

This is the first edition of CSA ISO 20166-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 20166-1 (first edition, 2018-12). For brevity, this Standard will be referred to as "CSA ISO 20166-1" throughout. CSA Group acknowledges that the development of this Standard was made possible, in part, by the financial support of governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH). This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Medical Laboratory Quality Systems, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. 

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. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro 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.