ISO/AWI TS 17849

Guidance on the validation and verification of quantitative and qualitative methods

General information

Current stage: 20.00 New project registered in TC/SC work programme Jun 19, 2025

Originator: ISO

Owner: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

Type: Technical Specification

Scope

This document provides guidance on a risk-based approach to the validation and verification of medical laboratory examinations. It outlines the general principles and evaluation criteria by which examination methods can be validated and verified for use by medical laboratories.

Life cycle

NOW

IN_DEVELOPMENT
ISO/AWI TS 17849
20.00 New project registered in TC/SC work programme
Jun 19, 2025