IS 12572 : Part 9 : 1988 Guide for evaluation of medical devices for biological hazards Part 9 Method of test for skin irritation by solid medical devices

1 Scope

1.1 This standard (Part 9) describes a method of test designedto assess the irritation of skin by medical devices in directcontact.

1.2 The test material is applied to the skin for fiveconsecutive days.

1.3 This method of test is recommended where practicable for theinitial assessment of devices in Categories C, D and E, (see Part 2of this standard), that is:

a) Category C - Those intended for short term (short-term coversa period from a few minutes to severals weeks continuous use) usewithin the body or in contact with the mucosal surfaces, such as,tracheal tubes, urinary catheters, intravenous cannulae.

b) Category D - Those intended to be used in contact with theskin, such as, splints.

c) Category E₂ - Those intended to be used tocontain or administer substances by means of routes other thanthose in Category E₁, such as, eyedrop containers.