CEI UNI EN ISO 14971 : 2013现行
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
出版：Comitato Elettrotecnico Italiano
专家解读视频
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.
UNI CEI EN ISO 14971 : 2012 - Identical
EN ISO 14971 : 2012 - Identical
ISO 14971 : 2007(R2010) - Identical
UNI CEI EN ISO 14971 : 2012 - Identical
EN ISO 14971 : 2012 - Identical
ISO 14971 : 2007(R2010) - Identical
