Sky Bear Technical Standards - Home
Search
×
FR

Placeholder headline

This is just a placeholder headline

B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

$

362

BUY NOW

ISO 5798:2022

ISO 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

CDN $347.00

Description

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.

Edition

1

Published Date

2022-04-19

Status

PUBLISHED

Pages

44

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

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.

Previous Editions

Can’t find what you are looking for?

Please contact us at: