Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
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.
This document is available in electronic format only.
Date of Publication: May 1, 2021
Order Code PDF: ISO201843E
Order Code Print: print not available
ISO 20184-3:2021 Additional Details
Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.