A search revels
“ISO 14971 is an ISO standard for the application of risk management to medical devices.The ISO Technical Committee responsible for the maintenance of this standard is ISO TC 210 working with IEC/SC62A through Joint Working Group one (JWG1). This standard is the culmination of the work starting in ISO/IEC Guide 51”

this is a standard acceptable in countries around the world, this is a system of risk management that builds. and its purpose is to
Establish a process to manage and control the risks associated with your organization’s medical devices. Document your organization’s medical device risk management process.
Apply your risk management process to your organization’s medical devices.
Maintain your risk management process for every medical device throughout its entire life-cycle.

http://www.praxiom.com/iso-14971.htm

ISO Catalogue: Medical devices — Application of risk management to medical devices
http://www.iso.org/iso/catalogue_detail.htm?csnumber=53940