ISO/TS 5798:2022 PDF

ISO/TS 5798:2022 PDF

Name:
ISO/TS 5798:2022 PDF

Published Date:
04/01/2022

Status:
Active

Description:

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

Publisher:
International Organization for Standardization (Technical Standard)

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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Choose Document Language:
$66.9
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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.


File Size : 1 file , 3.7 MB
Note : This product is unavailable in Russia, Ukraine, Belarus
Number of Pages : 52
Published : 04/01/2022
Same As : ISO/TS 5798:2022

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