99.60 Withdrawal effective Feb 18, 2020
IEC
International Standard
11.040.01 Medical equipment in general
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.
WITHDRAWN
ISO 14971:2007 ED2
99.60
Withdrawal effective
Feb 18, 2020
PUBLISHED
ISO 14971:2019 ED3