ISO/TS 5798:2022
p
ISO/TS 5798:2022
81712

Abstract

 Preview

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.


General information 

  •  :  Published
     : 2022-04
  •  : 1
     : 44
  •  : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
  •  :
    11.100.01 Laboratory medicine in general

Buy this standard

en
Format Language
std 1 158 PDF + ePub
std 2 158 Paper
  • CHF158

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information.