Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA
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 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
This document is available in electronic format only.
Date of Publication: December 1, 2018
Order Code PDF: ISO201661E
Order Code Print: print not available
ISO 20166-1:2018 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.