- Abstract:This document describes considerations for the design, development, verification, validation, and implementation of analytical assays for the detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods. It covers pretest and investigational process steps for respiratory specimens and their relevant parameters. This document is applicable to medical laboratories. It is also for use by laboratory clients of laboratories, developers and manufacturers of in vitro diagnostics, and institutions and organizations conducting and/or supporting SARS-CoV-2 research.
- Document number:DIN CEN ISO/TS 5798
- Issuing date:2023-03-01
- Document type:Vornorm
- Title: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 (ISO/TS 5798:2022); German version CEN ISO/TS 5798:2022
- Author:Medical Standards Committee
- Search term:Analysis; Biology; Biomarkers; Corona; Definitions; Determination procedures; Investigations; In-vitro diagnostic; Laboratory tests; Medical sciences; Methods of analysis; Molecular structure; Nucleic acids; Quality assurance; Testing; Verification; Viruses
- Application areas:09.10 Medizinische Produkte; 30.01 Persönliche Schutzausrüstungen im Allgemeinen
- Hazards:AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; BB Mikroorganismen (Viren, Bakterien, Parasiten u. Ä.)
- ICS:11.100.01 Laboratory medicine in general
- Price:136,20 EUR
- Cross references:DIN EN ISO 4307 (2022-02); DIN EN ISO 9000 (2015-11); DIN EN ISO 13485 (2021-12); DIN EN ISO 15193 (2009-10); DIN EN ISO 15194 (2009-10); DIN EN ISO 17511 (2021-11); DIN EN ISO 18113-1 (2013-01); DIN EN ISO 20184-1 (2019-06); DIN EN ISO 20184-2 (2019-06); DIN EN ISO 20184-3 (2021-11); DIN EN ISO 20186-1 (2019-08); DIN EN ISO 20186-2 (2019-08); DIN EN ISO 20186-3 (2020-04); DIN EN ISO 20387 (2020-11); DIN EN ISO 22174 (2005-05); ISO/IEC Guide 99 (2007-12); ISO 4307 (2021-10); ISO 9000 (2015-09); ISO 13485 (2016-03); ISO 13495 (2013-11); ISO 15189 (2022-12); ISO 15190 (2020-02); ISO 15193 (2009-05); ISO 15194 (2009-05); ISO/TS 16393 (2019-02); ISO 16577 (2022-08); ISO 17511 (2020-04); ISO 17822 (2020-11); ISO 18113-1 (2022-10); ISO 20184-1 (2018-11); ISO 20184-2 (2018-11); ISO 20184-3 (2021-05); ISO 20186-1 (2019-02); ISO 20186-2 (2019-02); ISO 20186-3 (2019-09); ISO 20387 (2018-08); ISO 20395 (2019-08); ISO 22174 (2005-02); ISO 22609 (2004-12); ISO 23640 (2011-12); ISO 35001 (2019-11); DIN EN ISO 15189 (2023-03)
- Identical with:CEN ISO/TS 5798(2022-11)<IDT>; ISO/TS 5798(2022-04)<IDT>
- Update flag:Unchanged