AS ISO 5649:2025
AS ISO 5649:2025
Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed testsstandard by Standards Australia , 04/11/2025
standard by Standards Australia , 04/11/2025
AS ISO 5649:2025 identically adopts ISO 5649:2024, which specifies requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions