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Draft standard [New]

DIN EN ISO 22367

Medical laboratories - Application of risk management to medical laboratories (ISO/DIS 22367:2025); German and English version prEN ISO 22367:2025
Edition 2025-05

Standards [CURRENT]

DIN EN ISO 22367

Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020); German version EN ISO 22367:2020
Edition 2020-09

Technical Specification

DIN CEN/TS 17811

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA; German version CEN/TS 17811:2022
Edition 2022-08

Standards [CURRENT]

DIN EN ISO 5649

Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests (ISO 5649:2024); German version EN ISO 5649:2024
Edition 2025-04

Standards [CURRENT]

DIN EN ISO 15189

Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022 + A11:2023
Edition 2024-08

Draft standard

DIN EN ISO 18704

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for urine and other body fluids - Isolated cell free DNA (ISO/DIS 18704:2024); German and English version prEN ISO 18704:2024
Edition 2024-12

Publication

Professionelles Risikomanagement von Medizinprodukten

Ein Leitfaden zur praktischen Umsetzung der DIN EN ISO 14971 im Fokus der MDR- und IVDR-Anforderungen
Edition 2023-05

Publication

Konformitätsbewertung und Akkreditierung

Normensammlung und systematische Einführung
Edition 2024-08

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