BS 5736-6(1983) : 1983被替代
EVALUATION OF MEDICAL DEVICES FOR BIOLOGICAL HAZARDS - METHODS OF TEST FOR SENSITIZATION ASSESSMENT OF THE POTENTIAL OF MEDICAL DEVICES TO PRODUCE DELAYED CONTACT DERMATITIS
出版：British Standards Institution
专家解读视频
Details tests to provide information on the potential to induce delayed contact dermatitis attributable to endogenous or extraneous substances present in or on a medical device. Defines grading of the skin reactions produced in guinea pigs following administration of prepared ingredients, and/or extracts of the device prepared using both a polar and a non-polar solvent. Describes a test using a combined intradermal injection and topical application and an alternative suing topical application only. Recommended for hte initial assessment of certain categories of devices. Certain results to be assessed by a toxicologist.
