General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
Edition 2002-08

Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts
Edition 2002-08

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
Edition 2003-11

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
Edition 2003-05

Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)
Edition 2024-12

Performance evaluation of in vitro diagnostic medical devices
Edition 2002-02

Performance evaluation of in vitro diagnostic medical devices; Amendment AC
Edition 2003-01

In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
Edition 1999-06

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)
Edition 2003-08