PN EN ISO 14971 : 2012現行
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
出版：Polish Committee for Standardization
專家解讀視頻
Defines 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.
ISO 14971 : 2007(R2010) - Identical
EN ISO 14971 : 2012 - Identical
ISO 14971 : 2007(R2010) - Identical
EN ISO 14971 : 2012 - Identical
