IS 12572 : Part 11 : 1990 Guide for evaluation of medical devices for biological hazards Part 11 Method of tests for eye irritation

1 Scope

1.1 The standard (Part 11) describes of method of test designedto assess the ocular irritation of leachable endogenous orextraneous substances present in or on a medical device.

1.2 This method specifies the use of either a polar solvent or anonpolar solvent to obtain extructs. The polar solvent is used toobtain extracts from devices that are intended for use with polarliquids and the non-polar solvent is used to obtain extracts fromdevices that are intended for use either with or in contact withnon-polar liquids. In both the cases the extracts are administeredto the rabbit eye, using a multiple instillation procedure for thepolar solvent extract and a single instillation procedure for thenon-polar solvent extract.

1.3 This method of test is recommended for the initialassessment of devices in categories B₂ and E₂ of Part 2 of this standard, intended for use withpolar or non-polar solvents.

Category B₂

Those intended for long term (long term covers a period from afew months to permanent use) or repeated contact with cornea andconjunctive, for example contact lenses.

Category E₂

Those intended to be used to contain or administer substances bymeans of routes other than those in category E₁for example eyedrop containers.

1.4 The assessment of the result should be carried out by atoxicologist who is aware of the conditions of use of the finalproduct and has appropriate chemical and biological data concerningit (see 3.3 and 3.4 of Part 2 of this standard).