Title Of Document
Medical devices -- Application of risk management to medical devices
Abstract
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.
Category of Standards
Category 1
Document number assigned by ASEAN
ISO 14971:2007
ICS
HS
30.01 , 30.05 , 30.06 , 33.04 , 33.06 , 33.07 , 34.04 , 34.07 , 37.05 , 38.08 , 38.21 , 38.22 , 39.24 , 39.26 , 40.14 , 40.15 , 48.18 , 48.23 , 59.06 , 62.11 , 62.12 , 63.07 , 66.02 , 84.19 , 84.21 , 85.39 , 87.13 , 87.14 , 90.01 , 90.02 , 90.04 , 90.06 , 90.11 , 90.13 , 90.18 , 90.19 , 90.20 , 90.21 , 90.22 , 90.25 , 94.02 , 94.05
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Agreement on Medical Device Directive (AMDD)
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
Member States
Date of harmonisation in ASEAN
Date of Latest Review
Links :
ISO 14971:2007 Medical devices -- Application of risk management to medical devices