Testing of device from other lot or batch returned from user (Q51420): Difference between revisions
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A investigação empregou testes empíricos relevantes do dispositivo de outro lote ou lote diferente do dispositivo suspeito no evento adverso relatado, a fim de apoiar a identificação de possíveis causas para o evento adverso. Isso inclui dispositivos sem designação de lote. O dispositivo foi devolvido pelo usuário. Testes relevantes normalmente são baseados em métodos de teste usados para avaliar a segurança e o desempenho, conforme descrito no arquivo técnico. Testes relevantes normalmente são baseados em métodos de teste usados para avaliar a segurança e o desempenho, conforme descrito nos padrões relevantes mais recentes. | |||
| description / en | description / en | ||
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. | |||
Revision as of 22:36, 13 August 2026
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.
| Language | Label | Description | Also known as |
|---|---|---|---|
| default for all languages | XE4X1 |
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| English | Testing of device from other lot or batch returned from user |
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. |
