Abstract

IN RESPONSE TO THE COVID-19 CRISIS, THIS STANDARD IS PROVIDED FREE OF CHARGE TO UGANDAN ENTERPRISES/MANUFACTURERS UNTIL FURTHER NOTICE. TO REQUEST FOR A FREE COPY, SEND EMAIL TO maurice.musuga@unbs.go.ug or george.opiyo@unbs.go.ug.?? This Uganda Standard specifies the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of medical devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; and the assessment of the biological safety of the medical devices. (This standard cancels and replaces US ISO 10993-1:2003 which has been technically revised). This standard was PUBLISHED on 2019-10-01.