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

30.0130.0530.0633.0433.0633.0734.0434.0737.0538.0838.2138.2239.2439.2640.1440.1548.1848.2359.0662.1162.1263.0766.0284.1984.2185.3987.1387.1490.0190.0290.0490.0690.1190.1390.1890.1990.2090.2190.2290.2594.0294.05

HS Range

MRA/Harmonised Regulations related to the Standard

ASEAN Agreement on Medical Device Directive (AMDD)

ASEAN Body responsible for Standard

Medical Device Product Working Group (MDPWG)

Member States

Date of harmonisation in ASEAN

Date of Latest Review

Links :

ISO 14971:2007 Medical devices -- Application of risk management to medical devices