PD CEN/TS 16826-1:2015 PDF

Scope: This Technical Specification gives recommendations for the handling, documentation and processing of frozen tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e. g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities). RNA profiles in tissues can change significantly before and after collection and can change differently in tissues from different donors / patients. Therefore, it is essential to take special measures to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis. Tissues that have undergone chemical stabilisation pre-treatment before freezing are not covered in this document.

PD CEN/TS 16826-1:2015 Referenced Document

EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)*， 2024-04-20 Update
EN ISO 22174:2005 Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection of food-borne pathogens - General requirements and definitions
ISO 15190:2003 Medical laboratories - Requirements for safety
ISO Guide 30:1992 Terms and definitions used in connection with reference materials

2015 PD CEN/TS 16826-1:2015 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA