ISO 20184-3:2021 PDF

Scope: This document specifies requirements and gives recommendations for the handling, storage, processing, and documentation of frozen tissue specimens intended for DNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that evaluate DNA isolated from frozen tissue. 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. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

ISO 20184-3:2021 Referenced Document

ISO 15189 Medical laboratories - Requirements for quality and competence [Standard in Spanish]
ISO 15190 Medical laboratories — Requirements for safety

2021 ISO 20184-3:2021 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA