Resumen
ϲʿ 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
The principles set forth in ϲʿ 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.
ϲʿ 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
ϲʿ 14155:2011 does not apply to in vitro diagnostic medical devices.
Ciclo de vida
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Anteriormente
Retiradaϲʿ 14155-1:2003
Retiradaϲʿ 14155-2:2003
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Ahora
Correcciones
Corrigen la edición actual; gratuitas; no incluidas en el texto de la norma existente.Retiradaϲʿ 14155:2011/Cor 1:2011
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Revisada por
Publicadoϲʿ 14155:2020
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