Skip to main content

Sorry - this product is no longer available

prEN ISO 5649

Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023)

General information

Base Documents
ISO/DIS 5649; prEN ISO 5649
Directives or regulations

Standard history

prEN ISO 5649
The proposed standard document specifies requirements for ensuring quality, safety and performance of laboratory-developed tests (LDT). It outlines the general principles and assessment criteria by which LDT shall be designed, developed, manufactured, validated and monitored for internal use by medical laboratories.
While the proposed standard follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within certain disciplines of medical laboratory testing.
This document does not cover requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-in-vitro-diagnostic purposes. However, the concepts presented in this document may also be useful for these institutions.
The proposed standard does not apply to the design, development and industrial production of commercially used in vitro diagnostic medical devices.

Required fields are indicated with *

10.98 € incl tax
10.98 € incl tax
Standard monitoring

Customers who bought this item also bought


EVS-EN ISO 14001:2015

Environmental management systems - Requirements with guidance for use (ISO 14001:2015)
Newest version Valid from 06.10.2015

EVS-EN ISO 9004:2018

Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018)
Newest version Valid from 03.05.2018
Main + amendment

EVS-EN IEC 61010-2-101:2022+A11:2022

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2018)
Newest version Valid from 01.12.2022

EVS-EN ISO/IEC 17043:2023

Conformity assessment - General requirements for the competence of proficiency testing providers (ISO/IEC 17043:2023)
Newest version Valid from 01.09.2023