IS 12572 : Part 8 : 1988 Guide for evaluation of medical devices for biological hazards Part 8 Method of test for skin irritation of extracts from medical devices: and

1 Scope

1.1 This standard describes a test method designed to assess theirritation of skin by leachable endogenous or extraneous substancespresent in or on a medical device. This method specifies the use ofboth polar and non-polar solvents to obtain extracts of devices.These extracts are administered by application to the skin for fiveconsecutive days.

1.2 This method of test is recommended for the initialassessment of devices in Group C, D and E₂, thatis:

a) Category C - Those intended for short-term (short-term coversa period from a few minutes to several weeks continuous use) usewithin 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 theskin, such as, splints;

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