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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 >
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, 2022
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Overview [Go to Page]
- 5 Laboratory requirements [Go to Page]
- 6 Design and development [Go to Page]
- 7 Verification for patient care [Go to Page]
- 8 Validation for patient care [Go to Page]
- 9 Design transfer to production
- 10 Implementation and use in the laboratory and reporting of results [Go to Page]
- 11 Quality assurance [Go to Page]
- Annex A (informative) Nucleic acid amplification techniques
- Bibliography [Go to Page]