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Normentext, Erläuterungen, Ergänzungen, Musterformulare
Edition
2016-04
Nicht aktive Medizinprodukte
Horizontale Europäische Normen in Anlehnung an entsprechende EU-Richtlinien und -Verordnungen
Edition
2022-06
DIN 6827-2
Recording of the medical application of ionizing radiation - Part 2: Diagnosis and therapy using unsealed radioactive materials
Edition
2012-03
DIN 58964
Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation
Edition
2015-09
DIN EN ISO 4307
Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021); German version EN ISO 4307:2021
Edition
2022-02
DIN EN ISO 16256
Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases (ISO 16256:2021); German version EN ISO 16256:2021
Edition
2022-02
DIN EN ISO 6717
In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021); German version EN ISO 6717:2021
Edition
2021-12
DIN 6812
Medical X-ray equipment up to 300 kV - Rules of construction for structural radiation protection
Edition
2021-06
DIN EN ISO 20776-2
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021); German version EN ISO 20776-2:2022
Edition
2022-04
DIN EN ISO 5649
Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO/DIS 5649:2023); German and English version prEN ISO 5649:2023
Edition
2024-02