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      • ISO/TS 5798:2022
      Codes & Standards - Purchase

      ISO/TS 5798:2022

      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

      SKU: iso_081712_184291 Published by ISO Publication Year 2022 1 Edition 44 pages

      Product Details

      • Overview
      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.

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      GST REG No R119441681
      QST REG No R1006017360

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