SK EN ISO 14971:2013
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Status: Withdrawn
Gjuha: English Faqe: 99 Publikuar: 2013-11-26 I tërhequr: 2022-04-04 Regjistri Kombëtar: 390/2022 Botim: |
Standardet ndërkombëtare që kanë lidhje
This standard is identical to:
EN ISO 14971:2012 CEN/CLC/JTC 3 |
Çmim: 48 €
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Titulli Shqip
Pajisje mjekësore -Zbatimi i drejtimit të rrezikut në pajisjet mjekësore (ISO 14971 : 2007, Versioni i korrigjuar 2007 -10 -01)
Titulli Anglisht
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Scope Shqip
Asnjë informacion i shtuar.
Scope Anglisht
ISO 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 ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.