PD ISO/TS 5798:2022 PDF
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
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
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 апреля 2022 г.
- ICS:
- 11.100.01
- SKU:
- PD ISO/TS 5798:2022
Abstract
1 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 .
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