Standard Svensk standard · SS-EN ISO 20166-2:2019

Molekylärbiologiska in-vitro diagnostiska undersökningar - Riktlinjer för pre-analytiska processer för formalinfixerad och paraffininbäddad (FFPE) vävnad - Del 2: Isolerade proteiner (ISO 20166-2:2018)

Status: Gällande

Omfattning
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for the examination of isolated proteins during the pre-examination phase before a molecular assay is performed. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable for protein examination by immunohistochemistry. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Ämnesområden

(11.100.10)


Produktinformation

Språk: Engelska

Framtagen av: Laboratoriemedicin, SIS/TK 331

Internationell titel: Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins (ISO 20166-2:2018)

Artikelnummer: STD-80009255

Utgåva: 1

Fastställd: 2019-01-08

Antal sidor: 32