JIS Q 14971-1:2001 English Edition

Medical devices - Risk management Part 1: Application of risk analysis

Abstract

This part of JIS Q 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 or particular assistance in areas where relevant standards are not available or not used. This part of JIS Q 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 JIS Q 14971 is not intended to give guidance on all aspects of management of risks. Furthermore, it is not intended to cover decision-marking processes regarding assessment of the indications and contra-indications for the use of a particular device.

Details

Note
We will send the latest version to you, please contact us if you want the exact document as the title. Some old Standards are in scancopy and no reaffirmed stamp