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ISO 20166-2:2018

Molecular in vitro diagnostic examinations — Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue — Part 2: Isolated proteins
30. 11. 2018.

Опште информације

90.93     12. 12. 2024.

ISO

ISO/TC 212

Међународни стандард

11.100.10  

енглески   француски  

Куповина

Објављен

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Апстракт

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.

Животни циклус

ТРЕНУТНО

ОБЈАВЉЕН
ISO 20166-2:2018
90.93 Одлука о потврђивању стандарда
12. 12. 2024.

РЕВИДИРАН ОД

ПРОЈЕКАТ
ISO/PWI 20166-2

Национална преузимања

Molekularna in vitro dijagnostička ispitivanja – Specifikacije za procese pre ispitivanja za tkivo fiksirano u formalinu i ukalupljeno u parafinu (FFPE) – Deo 2: Izolovani proteini

60.60   Стандард објављен