ISO/TS 5798:2022

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Тезис

This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.

This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.

This document does not apply to environmental samples.

Общая информация

Текущий статус
: Опубликовано

Дата публикации
: 2022-04
Версия
: 1
Технический комитет
: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ICS
:
11.100.01 Laboratory medicine in general