ISO 17822:2020
In vitro diagnostic test systems - Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide
- Standard No.
- ISO 17822:2020
- Release Date
- 2020
- Published By
- International Organization for Standardization (ISO)
- Latest
- ISO 17822:2020
- Scope
- This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT). It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.
ISO 17822:2020 Referenced Document
- ISO 15189 Medical laboratories - Requirements for quality and competence [Standard in Spanish]
- ISO 15190 Medical laboratories — Requirements for safety
ISO 17822:2020 history
- 2020 ISO 17822:2020 In vitro diagnostic test systems - Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide
