標準號：IS 12572 Pt.8-1988
發布日期：1989/10/1 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：1.1 This standard describes a test method designed to assess the irritation of skin by leachable endo-genous or extraneous substances present in or on a medical device. This method specifies the use of both polar and non-polar solvents to obtain extracts of devices. These extracts are administered by application to the skin for five consecutive days.1.2 This method of test is recommended for the initial assessment of devices in Group C, D and E2 ( see Part 2 of this standard ), that is:a) Category C — Those intended for short-term (short-term covers a period from a few minutes to several weeks continuous use ) use within the body or in contact with the mucosal surfaces, such as, tracheal tubes, urinary catheters, intravenous canulae;b) Category D — Those intended to be used in contact with the skin, such as, splints;c) Category E2 — Those intended to be used to contain or administer substances by means of routes other than those in Group E1 such as, eyedrop containers.