This document outlines essential requirements and recommendations for handling, storing, processing, and documenting frozen tissue specimens for DNA examination during the pre-examination phase. It supports molecular in vitro diagnostic (IVD) testing, including laboratory-developed tests, helping medical laboratories, molecular pathology labs, IVD developers, biobanks, and research institutions ensure high-quality DNA analysis. Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered.

NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.