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ISO - TS 5798

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

active, Most Current
Organization: ISO
Publication Date: 1 April 2022
Status: active
Page Count: 52
ICS Code (Laboratory medicine in general): 11.100.01
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.

Document History

TS 5798
April 1, 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
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory...

References

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