This document specifies requirements and gives recommendations for the collection, handling, documentation, transport, storage and processing during the pre-examination phase of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for qualitative and/or (semi-)quantitative in situ examination of the morphology and of biomolecules, such as metabolites, proteins, DNA and/or RNA, on FFPE tissue sections by using different in situ detection techniques.

This document is applicable to in vitro diagnostic examinations using in situ detection techniques. These include laboratory developed tests performed by pathology laboratories (histopathology laboratories) as well as by molecular pathology laboratories and other medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, as well as institutions and commercial organizations performing biomedical research, and regulatory authorities.

This document is not applicable to the pre-examination phase of RNA, proteins and DNA isolated from FFPE tissue for examination. These are covered in ISO°20166-1, ISO°20166-2 and ISO°20166-3, Molecular in vitro diagnostic examinations°°°° Specifications for pre-examination processes for isolated RNA, proteins and DNA, respectively.

Different dedicated measures are taken for pre-examination processes for fine needle aspirates (FNAs). These are covered in CEN WI°00140128, CEN WI°00140126, and CEN WI°00140129, Molecular in vitro diagnostic examinations°°°° Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) isolated cellular RNA, isolated proteins, and isolated genomic DNA, respectively.

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