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Overview - EN ISO 5649:2024 (Medical laboratories & LDTs) EN ISO 5649:2024 (published December 2024; prepared by ISO/TC 212 in cooperation with CEN/TC 140) provides a structured, state‑of‑the‑art fra…
1 Scope This document establishes requirements for assuring quality, safety , performance and documentation of laboratory-developed tests ( LDTs ) as per their intended use for the diagnosis, prognos…
Overview - What ISO 5649:2024 covers ISO 5649:2024 defines concepts and requirements for the design, development, implementation and use of laboratory‑developed tests (LDTs) in medical laboratories.…