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AS ISO 5649:2025
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AS ISO 5649:2025 Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
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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
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AS ISO 5649:2025 Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests