Abstract

This Uganda Standard specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This standard is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). This standard was PUBLISHED on 2011-12-20.