60.60 Standard published May 26, 2021
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
11.100.10 In vitro diagnostic test systems
Published
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.
WITHDRAWN
CEN/TS 16826-3:2018
PUBLISHED
EN ISO 20184-3:2021
60.60
Standard published
May 26, 2021