scope:

Specifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risks associated with the device. It is of particular assistance in areas where relevant standards are not available or not used. This standard does not stipulate levels of acceptability, which because they are determined by a multiplicity of factors, cannot by their nature be set down in such a standard. This standard is not intended to give detailed guidance on 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.