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
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
Order from Beuth Verlag
