DPS
Drejtoria e Përgjithshme e Standardizimit
0 Produkte
Llogaria ime
E-albania
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

ISO/TS 5798:2022

In vitro diagnostic test systems — Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
19 pri 2022

General information

60.60     19 pri 2022

ISO

ISO/TC 212

Technical Specification

11.100.01  

anglisht   frëngjisht  

Buying

Publikuar

Language in which you want to receive the document.

Scope

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.

Life cycle

NOW

PUBLISHED
ISO/TS 5798:2022
60.60 Standard published
19 pri 2022

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.

Login