Објављен
This document gives guidelines on the handling, documentation, storage and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens intended for DNA examination 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.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
ОБЈАВЉЕН
ISO 20166-3:2018
90.93
Одлука о потврђивању стандарда
12. 12. 2024.
ПРОЈЕКАТ
ISO/PWI 20166-3
Molekularna in vitro dijagnostička ispitivanja – Specifikacije za procese pre ispitivanja za tkivo fiksirano u formalinu i ukalupljeno u parafinu (FFPE) – Deo 3: Izolovani DNK
60.60 Стандард објављен