IS 12572 Pt.9-1988

标准号：IS 12572 Pt.9-1988
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 9 ) describes a method of test designed to assess the irritation of skin by medical devices in direct contact.1.2 The test material is applied to the skin for five consecutive days.1.3 This method of test is recommended where practicable for the initial assessment of devices in Categories 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 severals weeks continuous use) use within the body or in contact with the mucosal surfaces, such as, tracheal tubes, urinary catheters, intrave-nous cannulae.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 Category E1 such as, eyedrop containers.