Testing of model variant (Q52015): Difference between revisions
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A investigação empregou testes empíricos relevantes de uma variante do modelo do dispositivo envolvido no evento adverso relatado para apoiar a identificação de possíveis causas para o evento adverso por meio de raciocínio de plausibilidade. Uma variante de modelo não é idêntica ao dispositivo real, mas compartilha características relevantes com o dispositivo envolvido. 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 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. | |||
Revision as of 23:15, 13 August 2026
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.
| Language | Label | Description | Also known as |
|---|---|---|---|
| default for all languages | XE1XT |
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| English | Testing of model variant |
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. |
