11.100.10 In vitro diagnostic test systems

BS ISO 20916. In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

BS EN 61326-2-6. Electrical equipment for measurement, control and laboratory use. EMC requirements Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment

BS EN IEC 61326-2-6. Electrical equipment for measurement, control and laboratory use. EMC requirements Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment

BS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Part 1. Terminology and general requirements for nucleic acid quality evaluation

BS EN ISO 17511. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

BS ISO 21151. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples

General requirements for in vitro diagnostic medical devices for self-testing

Performance evaluation of in vitro diagnostic medical devices

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans