Draft International Standard
ISO/DIS 5649
Medical laboratories — Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
Reference number
ISO/DIS 5649
Edition 1
Draft
International Standard
Read sample
ISO/DIS 5649
81506
This Draft International Standard is in the enquiry phase with ISO members.

ISO/DIS 5649

ISO/DIS 5649
81506
Language
Format
CHF 63
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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.

General information

  •  : Under development
    : Full report circulated: DIS approved for registration as FDIS [40.99]
  •  : 1
     : 35
  • ISO/TC 212
    11.100.10 
  • RSS updates

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