IVDMDD Horizontal Standards
EN 12322
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
EN 13975
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
EN 14254
In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
EN ISO 15193
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
EN ISO 15194
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
EN ISO 15197
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus