Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation
Edition 2015-09

In vitro diagnostic medical devices - Requirements for reference measurement procedures (ISO/DIS 15193:2023); German and English version prEN ISO 15193:2023
Edition 2024-02

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021
Edition 2021-11

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); German version EN ISO 8871-4:2006
Edition 2006-09

In vitro diagnostic medical devices - Requirements for certified reference materials and the content of supporting documentation (ISO/DIS 15194:2023); German and English version prEN ISO 15194:2023
Edition 2024-02

Soil quality - Laboratory methods for determination of microbial soil respiration (ISO 16072:2002); German version EN ISO 16072:2011
Edition 2011-09

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022); German version EN ISO 18113-2:2024
Edition 2024-10

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003
Edition 2003-11

Water quality - Determination of the estrogenic potential of water and waste water - Part 3: In vitro human cell-based reporter gene assay (ISO 19040-3:2018); German version EN ISO 19040-3:2022
Edition 2023-12

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
Edition 2018-02