ISO 5649:2024

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ISO 5649:2024 is an international standard that specifies requirements for the design, development, implementation, and use of laboratory-developed tests (LDTs) in medical laboratories. It ensures the quality, safety, and performance of LDTs, aiming to provide accurate and reliable diagnostic results. The standard also addresses documentation and the use of LDTs for diagnosis, prognosis, monitoring, prevention, or treatment of medical conditions.