XE6FS
Testing of patient sample or reference material using manufacturer's device
Teste de amostra de paciente ou material de referência usando o dispositivo do fabricante
CategoryDefinition
The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.
Index Terms
Testing of patient sample or reference material using manufacturer's device