title: Risk management for IEC 60601-1 third edition.
abstract: With the examples above we have demonstrated for our selected topics that our device meets the risk management requirements of 60601-1. An expansion of the tables to include all of the risk management requirements would be useful to identify how the manufacturer has met all of the risk management requirements of the standard. By setting up a file system under the manufacturer's quality system that meets the requirements of the 14971 risk management standard, the manufacturer will be able to effectively demonstrate compliance with a number of applicable standards, including 60601-1, and also be able to demonstrate the device meets FDA product safety requirements. The file system would also be useful in creating the technical file for the MDD. A risk management summary table similar to the one recommended by the GHTF will assist the manufacturer in tracking the documentation required to support this effort. A list of the hazards identified for the product is contained in the summary table and the summary table will also aid in determining if all of the required steps in the risk management process have been completed for each hazard. This table will become an important record in the risk management file.
authors.affiliation: Bilanx Consulting LLC. ed.bills@bilanxconsulting.com
authors.forename: Edwin
authors.initials: E
authors.lastname: Bills
mesh_terms: D020811:Biomedical Technology; D004203:Disinfection / Q000592:standards; D008284:Maintenance and Engineering, Hospital / Q000592:standards*; D012308:Risk Management / Q000592:standards*; D017751:Safety Management; D013242:Sterilization / Q000592:standards; D014481:United States