ISO 14971:2007

Medical devices — Application of risk management to medical devices

Datum objavljivanja: 28. 2. 2007.

95.99 Povučen 10. 12. 2019.

Опште информације

Trenutna faza: 95.99 Effective date: 10. 12. 2019.

Inicijator: ISO

Pripada: ISO/TC 210

Vrsta: Međunarodni standard

ICS: 11.040.01

Jezik: engleski francuski

Kupovina

Status: Povučen

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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.