XE4X1 Testing of device from other lot or batch returned from user
International Classification of Diseases for Mortality and Morbidity Statistics, 11th Revision, v2024-01
The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. 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 technical file. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards.
synonyms
- Testing of device from other lot or batch returned from user
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