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DIN 58964
Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation
Edition
2015-09
DIN EN ISO 15193
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
DIN EN ISO 17511
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
DIN EN ISO 8871-4
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
DIN EN ISO 15194
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
DIN EN ISO 16072
Soil quality - Laboratory methods for determination of microbial soil respiration (ISO 16072:2002); German version EN ISO 16072:2011
Edition
2011-09
DIN EN ISO 18113-2
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
DIN EN ISO 18153
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
DIN EN ISO 19040-3
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
DIN EN ISO 10993-16
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