
EVALUATION OF MEDICAL DEVICES FOR BIOLOGICAL HAZARDS - METHOD OF TEST FOR SKIN IRRITATION OF EXTRACTS FROM MEDICAL DEVICES
出版:British Standards Institution

专家解读视频
Details tests to assess the irritation of skin by leachable endogenous or extraneous substances in or on a medical device. Defines the use of both polar and non-polar solvents to obtain extracts of devices. Recommended for the initial assessment of devices designed for short-term use within the body or in contact with mucosal surfaces, tracheal tubes, urinary catheters, intravenous cannulae, used in contact with the skin, splints, and those used to contain or administer substances, eyedrop containers. Advises results be assessed by a toxicologist.