IS 12572 Pt.7-1988

标准号：IS 12572 Pt.7-1988
发布日期：1989/9/1 12:00:00
实施日期：1999/12/31 12:00:00
适用范围：1.1 This standard ( Part 7 ) prescribes methods of test designed to provide information on the potential to induce delayed contact dermatitis (Type IV sensitization) attributable to endoge-nous or extraneous substances present in or on a medical device. The methods specify grading of the skins reaction produced in guinea pigs follow-ing administration of prepared ingredients, and/or extracts of the device prepared using both a polar and a non-polar solvent.1.2 Two test methods are prescribed:a) Method 1 uses a combined intradermal injection and topical application,b) Method 2 uses topical application only.Method 1 is the preferred method. Method 2 is to be used as an alternative to Method 1 if intra-dermal injection is not possible.1.3 These methods of test are recommended for the initial assessment of all the categories of devices given in Part 2 of this standard.