JSA - JIS T 14971
Medical devices - Application of risk management to medical devices
|Publication Date:||1 March 2012|
|ICS Code (Medical equipment in general):||11.040.01|
This Standard 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 this Standard are applicable to all stages of the life-cycle of a medical device.
This Standard does not apply to clinical decision making.
This Standard does not specify acceptable risk levels.
This Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
NOTE: The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.
ISO 14971: 2007 Medical devices-Application of risk management to medical devices (IDT)
In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21-1.
Furthermore, JIS T 14971: 2003 is applicable until 28 February 2015.