ISO 20166-3:2018

International Standard   Current Edition · Approved on 14 December 2018

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 Files

English 17 Pages
Current Edition
123.47 USD

ISO 20166-3:2018 Scope

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.

Best Sellers

GSO 150-2:2013
 
Gulf Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
YSMO GSO 150-2:2020
GSO 150-2:2013 
Yemeni Technical Regulation
Expiration dates for food products - Part 2 : Voluntary expiration dates
YSMO GSO 2055-1:2020
GSO 2055-1:2015 
Yemeni Standard
HALAL FOOD - Part 1 : General Requirements
GSO 2055-1:2015
 
Gulf Technical Regulation
HALAL FOOD - Part 1 : General Requirements

Recently Published

ISO 1952:2025
 
International Standard
Coal — Determination of extractable metals in dilute hydrochloric acid
ISO 5834-1:2025
 
International Standard
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form
ISO 5834-3:2025
 
International Standard
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods after gamma irradiation in air
ISO 15238:2025
 
International Standard
Coal — Determination of total cadmium