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prCEN ISO/TS 17849

Guidance on the validation and verification of quantitative and qualitative methods prCEN ISO/TS 17849

General information

10.99   New project approved   Jun 24, 2026

CEN

CEN/TC 140 In vitro diagnostic medical devices

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
prCEN ISO/TS 17849
10.99 New project approved
Jun 24, 2026




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