ICD-11 code : XE1XT;
Preferred Label : Testing of model variant;
ICD-11 definition : The investigation employed relevant empirical testing of a model variant of the device
involved in the reported adverse event in order to support the identification of possible
causes for the adverse event through plausibility reasoning. A model variant is not
identical to the actual device, but shares relevant characteristics with the device
involved. Relevant testing would typically be based on test methods used for evaluating
safety and performance as described in the latest relevant standards.;
Origin ID : 1886547997;
Currated CISMeF NLP mapping
The investigation employed relevant empirical testing of a model variant of the device
involved in the reported adverse event in order to support the identification of possible
causes for the adverse event through plausibility reasoning. A model variant is not
identical to the actual device, but shares relevant characteristics with the device
involved. Relevant testing would typically be based on test methods used for evaluating
safety and performance as described in the latest relevant standards.
