NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 15189 [Withdrawn] references following documents:

Document number Edition Title
ISO 17511 2020-04 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples More 
ISO 18113-1 2022-10 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements More 
ISO 19011 2018-07 Guidelines for auditing management systems More 
ISO 20166-1 2018-12 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA More 
ISO 20166-2 2018-12 Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins More 
ISO 20166-3 2018-12 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA More 
ISO 20166-4 2021-07 Molecular in vitro diagnostic examinations - Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 4: In situ detection techniques More 
ISO 20184-1 2018-11 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA More 
ISO 20184-2 2018-11 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 2: Isolated proteins More 
ISO 20184-3 2021-05 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA More