Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
more
In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
more
Single-use containers for human venous blood specimen collection
more
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
more
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
more
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
more
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
more
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
more
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
more
Electrical equipment for measurement, control and laboratory use - EMC requirements -- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
more
Medical device software - Software life-cycle processes
more
Medical devices - Application of usability engineering to medical devices
more
Safety requirements for electrical equipment for measurement, control, and laboratory use -- Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
more
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
more
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
more
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
more
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
more
Medical devices - Application of risk management to medical devices
more
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
more
terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
more
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
more
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
more
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
more