DS CEN 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 (ISO/TS 5798:2022)

Publication date: Aug 29, 2023

General information

Current stage: 60.60 Effective date: Aug 29, 2023

Originator: DPS

Owner: DPS/KT 140

Type: European Norm

ICS: 11.100.01

Languages: English

Buying

Status: Published

PDF - ALL 4,938

Paper - ALL 4,938

CD - ALL 4,938

PDF and Paper - ALL 9,876

Language

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.

Life cycle

NOW

PUBLISHED
DS CEN ISO/TS 5798:2022
60.60 Standard published
Aug 29, 2023

DS CEN 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 (ISO/TS 5798:2022)

General information

Buying

Scope

Life cycle

NOW

Related project

Adopted from CEN ISO/TS 5798:2022 IDENTICAL