Testing of patient sample or reference material using manufacturer's device (Q57119): Difference between revisions
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A investigação empregou testes empíricos relevantes de uma amostra de paciente ou material de referência usando o dispositivo (geralmente um IVD - diagnóstico in vitro) envolvido no evento adverso relatado para apoiar a identificação de possíveis causas para o evento adverso. 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 patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. 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 04:47, 14 August 2026
The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. 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 | XE6FS |
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| English | Testing of patient sample or reference material using manufacturer's device |
The investigation employed relevant empirical testing of a patient sample or reference material using the device (usually an IVD) involved in the reported adverse event in order to support the identification of possible causes for the adverse event. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. |
