BS EN ISO 20166-4:2021

What is ISO 20166-4 about?

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.

Who is ISO 20166-4 for?

ISO 20166-4 is applicable to-

• Pathology laboratories (histopathology laboratories)
• Medical laboratories and their customers
• Vitro diagnostics developers and manufacturers, biobanks, as well as institutions
• Commercial organizations performing biomedical research, and regulatory authorities

Why should you use ISO 20166-4?

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.