Resumen
ϲʿ 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ϲʿ 14971:2007 are applicable to all stages of the life-cycle of a medical device.
Ciclo de vida
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Anteriormente
Retiradaϲʿ 14971:2000
Retiradaϲʿ 14971:2000/Amd 1:2003
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Ahora
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Revisada por
Publicadoϲʿ 14971:2019
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