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.
Document published on: 2007-03 Edition: 2 (Monolingual) ICS: 11.040.01 Status: Published Stage: 90.92 (2016-11-14) TC/SC: ISO/TC 210 Number of Pages: 82
Revised by: ISO/NP 14971
Revises: ISO 14971:2000
Revises: ISO 14971:2000/Amd 1:2003
No corrigenda or amendments available