ISO 20166-4 is one of a series of documents for Molecular in vitro diagnostic examinations that specify 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.
ISO 20166-4 is not applicable to the pre-examination phase of RNA, proteins, and DNA isolated from FFPE tissue for examination. These are covered in ISO 201661, ISO 201662, and ISO 201663, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for isolated RNA, proteins, and DNA, respectively.
ISO 20166-4 is applicable to-
ISO 20166-4 draws upon such work to organize and standardize the steps for formalin-fixed and paraffin-embedded (FFPE) tissue regarding various in situ detection techniques in what is referred to as the pre-examination phase.
In ISO 20166-4 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.BSI recommends this version of standard for organisations operating in or with the UK. The ISO edition is available here if required.