標準號：IS 12572 Pt.11-1990
發布日期：1990/11/1 12:00:00
實施日期：1999/12/31 12:00:00
適用范圍：1.1 The standard ( Part 11 ) describes a method of test designed to assess the ocular irritation of leachable endogenous or extraneous substances present in or on a medical device.1.2 This method specifies the use of either a polar solvent or a nonpolar solvent to obtain extracts. The polar solvent is used to obtain extracts from devices that are intended for use with polar liquids and the non-polar solvent is used to obtain extracts from devices that are intended for use either with or in contact with non-polar liquids. In both the cases the extracts are administered to the rabbit eye, using a multiple instillation procedure for the polar solvent extract and a single instillation procedure for the non-polar solvent extract.1.3 This method of test is recommended for the initial assessment of devices in categories B2 and E2 of Part 2 of this standard, intended for use with polar or non-polar solvents.Category B2Those intended for long term ( long term covers a period from a few months to permanent use ) or repeated contact with cornea and conjunctive, for example contact lenses.Category E2Those intended to be used to contain or administer substances by means of routes other than those in category E1 for example eyedrop containers.1.4 The assessment of the result should be carried out by a toxicologist who is aware of the conditions of use of the final product and has appropriate chemical and biological data concerning it ( see 3.3 and 3.4 of Part 2 of this standard ).