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General requirements for in vitro diagnostic medical devices for self-testing
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
90.93 Standard confirmed
Performance evaluation of in vitro diagnostic medical devices
60.60 Standard published
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
90.93 Standard confirmed
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
90.93 Standard confirmed
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
90.93 Standard confirmed
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)
90.93 Standard confirmed
Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
30.00 Committee draft (CD) registered