This document specifies requirements and recommendations for the pre-examination handling of formalin-fixed, paraffin-embedded (FFPE) tissue specimens intended for in situ examination of morphology and biomolecules, such as metabolites, proteins, DNA, and RNA, using various in situ detection techniques. It applies to in vitro diagnostic (IVD) examinations performed in pathology, molecular pathology, and medical laboratories, as well as to IVD developers, biobanks, research institutions, and regulatory authorities.

This document does not cover the pre-examination phase for isolated RNA, proteins, or DNA, which are addressed in ISO 20166-1, ISO 20166-2, and ISO 20166-3, respectively. Additionally, pre-examination processes for fine needle aspirates (FNAs) are covered in CEN WI00140128, CEN WI00140126, and CEN WI00140129.

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