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Homepage>CSN Standards>85 HEALTH SERVICE>8570 Diagnostic systems in vitro>CSN P CEN 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

CSN P CEN 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

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Number of Standard:	CSN P CEN ISO/TS 5798
Category:	857045
Pages:	60
Released:	01.05.2023
Catalog number:	516700

DESCRIPTION

CSN P CEN ISO/TS 5798

CSN P CEN ISO/TS 5798 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.
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.

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