Tagasi

prEN ISO 5649

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

Üldinfo
Kavand
Alusdokumendid
ISO/DIS 5649; prEN ISO 5649
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
Põhitekst
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.
*
*
*
PDF
10,98 € koos KM-ga
Paber
10,98 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst

EVS-EN ISO 14001:2015

Keskkonnajuhtimissüsteemid. Nõuded koos kasutusjuhistega
Uusim versioon Kehtiv alates 06.10.2015
Põhitekst

EVS-EN ISO 9004:2018

Kvaliteedijuhtimine. Organisatsiooni kvaliteet. Juhised püsiva edu saavutamiseks
Uusim versioon Kehtiv alates 03.05.2018
Põhitekst + muudatus

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

Ohutusnõuded elektrilistele mõõtmis-, juhtimis- ja laboratooriumiseadmetele. Osa 2-101: Ohutusnõuded in vitro diagnostilistele (IVD) meditsiiniseadmetele
Uusim versioon Kehtiv alates 01.12.2022
Põhitekst

EVS-EN ISO/IEC 17043:2023

Vastavushindamine. Üldnõuded tasemekatsetuste korraldajatele
Uusim versioon Kehtiv alates 01.09.2023