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.

All current amendments available at time of purchase are included with the purchase of this document.

Product Details

Published:

04/30/2022

ISBN(s):

9780539171174

Number of Pages:

54

File Size:

1 file , 3.1 MB

Same As:

ISO/TS 5798:2022

Product Code(s):

30434721, 30434721, 30434721

Note:

This product is unavailable in Belarus, Russia, Ukraine