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DIN Standards Committee Health Technologies

Abstract

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.

Begin

2023-03-17

WI

00140161

Planned document number

DIN EN ISO 5649

Project number

06302217

Responsible national committee

NA 176-08-08 AA - Quality management in medical laboratories  

Responsible european committee

CEN/TC 140 - In vitro diagnostic medical devices  

Responsible international committee

ISO/TC 212/WG 1 - Quality and competence in the medical laboratory  

draft standard

Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023
2024-02
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