This part of ISO 14971 specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device. It may be of particular assistance in areas where relevant standards are not available or not used.
This part of ISO 14971 does not stipulate levels of acceptability because these are determined by a multiplicity of factors that cannot be set down in such a standard.
This part of ISO 14971 is not intended to give guidance on all aspects of management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for the use of a particular device.