Back

EVS-EN ISO 20166-3:2019

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018)

General information
Valid from 01.02.2019
Base Documents
ISO 20166-3:2018; EN ISO 20166-3:2019
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.02.2019
Main
02.09.2015
Main
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.
*
*
*
PDF
17.08 € incl tax
Paper
17.08 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 20166-1:2018

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA (ISO 20166-1:2018)
Newest version Valid from 03.01.2019
Main

EVS-EN 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 (ISO 20166-2:2018)
Newest version Valid from 03.01.2019
Main

EVS-EN ISO 4307:2021

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)
Newest version Valid from 15.11.2021
Main

EVS-EN IEC 61000-4-3:2020

Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test (IEC 61000-4-3:2020)
Newest version Valid from 31.12.2020