DIN EN ISO 20916:2024-07
In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019); German version EN ISO 20916:2024
| Fecha edición: |
2024-07-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | The scope of ISO 20916 is a good study practice which addresses the planning, design, conduct, recording and reporting of clinical performance studies for in vitro diagnostic medical devices (IVD). It provides recommendations on documentation and auditing to ensure the study's management compliance. The purpose of these studies is to assess the ability of an IVD medical device in the hands of the intended user, to yield results pertaining to a particular medical condition or physiological/pathological state, in the intended population. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. |
| Keywords: | Best practice|CE marking|Clinical|Clinical investigations|Clinical testing|Definitions|Diagnosis|Ethics|Human body|In vitro|In-vitro diagnostic|Medical examination|Medical sciences|Performance testing|Research|Responsibility|Specimens|Studies|Test materials |
| ICS: | 11.100.10 - Sistemas de ensayo para diagnóstico in vitro |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 20916:2024 Idéntica ISO 20916:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 20916:2021-05 |
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