ISO/DIS 5649
u
ISO/DIS 5649
81506

Status : Under development

en
Format Language
std 1 63 PDF
std 2 63 Paper
  • CHF63
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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.

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General information

  •  : Under development
    You can help develop this draft international standard by contacting your national member
    : DIS ballot initiated: 12 weeks [40.20]
  •  : 1
     : 35
  • ISO/TC 212
    11.100.10 
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