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Glavni meni

ISO 14971:2007 ED2

Medical devices - Application of risk management to medical devices
31. 3. 2007.

Опште информације

99.60     18. 2. 2020.

IEC

TC 62/SC 62A

Međunarodni standard

11.040.01  

engleski   francuski   ruski  

Kupovina

Revidiran

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 14971:2000 ED1

POVUČEN
ISO 14971:2000/AMD1:2003 ED1

TRENUTNO

POVUČEN
ISO 14971:2007 ED2
99.60 Povlačenje stupilo na snagu
18. 2. 2020.

REVIDIRAN OD

OBJAVLJEN
ISO 14971:2019 ED3