ISO 17822:2020

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ISO 17822:2020 is an international standard focused on ensuring the quality of clinical laboratory practices for nucleic acid amplification tests (NAATs) used to detect, identify, and quantify microbial pathogens. It specifically addresses the procedures used in in vitro diagnostic test systems. The standard is designed for laboratories that develop, implement, and use NAATs for medical, research, or health-related purposes. It doesn't apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers.