ISO/DIS 5649

недоступно на русском языке

Текущий статус : В стадии разработки

	Формат	Язык
std 1 63	PDF
std 2 63	Бумажный

CHF63

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Тезис

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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Общая информация

Текущий статус
: В стадии разработки

Этап
: Рассылка краткого отчета по итогам голосования [40.60]
Версия
: 1
Технический комитет :
ISO/TC 212

ICS :
11.100.10
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