ICD-11 code : XE4S0;
Preferred Label : Testing of device from same lot batch returned from user;
ICD-11 definition : The investigation employed relevant empirical testing of the device of the same lot
or batch as that of the suspected device in the reported adverse event in order to
support the identification of possible causes for the adverse event. The device was
returned from the user. Relevant testing would typically be based on test methods
used for evaluating safety and performance as described in the latest relevant standards.;
Origin ID : 171914268;
Automatic exact mappings (from CISMeF team)
The investigation employed relevant empirical testing of the device of the same lot
or batch as that of the suspected device in the reported adverse event in order to
support the identification of possible causes for the adverse event. The device was
returned from the user. Relevant testing would typically be based on test methods
used for evaluating safety and performance as described in the latest relevant standards.
