ISO 9394:2012 pdf download.Ophthalmic optics -Contact lenses and contact lens care products —Determination of biocompatibility by ocular study with rabbit eyes.
A minimum number of three rabbits shall be used, however a number of six is recommended to ensure an acceptable level of precision of the test results. If less than six rabbits are used, then the quantity shall be justified.
If control articles are included in the evaluation, use the contra-lateral eye or an additional group of animals with the same number of animals chosen as before for each control article For contact lens care products, the control group should use the same type of contact lens which has not been treated with the test product.
Positive controls shall not be used.
NOTE In this context, control article’ should be interpreted as being a device with defined safety and performance characteristics.
5.2 The animal welfare requirements set out in ISO 10993-2 shall be met.
5.3 The animals shall be housed individually and have free access to commercially pelted rabbit feed and tap water. Group housing is not feasible in this test since any lens found expulsed from the eye shall be matched to the specific rabbit which wore the lens and re-inserted into the same eye.
5.4 Each animal shall be identified by one of the following:
a) a numbered ear tag;
b) a tattoo;
c) a microchip; or
d) a permanent ink marking.
The animals shall be acclimatized to the laboratory conditions for at least five days prior to testing.
5.5 The nictitating membrane should not be removed from the rabbits’ eyes, and the eyelids should not be sutured during lens wear. Any deviations shall be justified and documented in the test report.
NOTE The albino rabbit eye is free of pigment, easily examined and has historically been used for ocular irritation studies. All appropriate regulatory requirements governing the care and use of animals shall be followed.
5.6 During daily treatment, the rabbits shall be minimally restrained.
6 Reagents/materials
6.1 Sodium fluorescein, as specified by an appropriate pharmacopoeia.
NOTE Attention should be made to the degree of staining and the concentration of fluorescein administered to the eye (e.g. 3 ul of 1 % fluorescein in saline solution).
6.2 Contact lens care products. as recommended by the manufacturers.
If control articles are included in the evaluation, use the contra-lateral eye or an additional group of animals with the same number of animals chosen as before for each control article For contact lens care products, the control group should use the same type of contact lens which has not been treated with the test product.
Positive controls shall not be used.
NOTE In this context, control article’ should be interpreted as being a device with defined safety and performance characteristics.
5.2 The animal welfare requirements set out in ISO 10993-2 shall be met.
5.3 The animals shall be housed individually and have free access to commercially pelted rabbit feed and tap water. Group housing is not feasible in this test since any lens found expulsed from the eye shall be matched to the specific rabbit which wore the lens and re-inserted into the same eye.
5.4 Each animal shall be identified by one of the following:
a) a numbered ear tag;
b) a tattoo;
c) a microchip; or
d) a permanent ink marking.
The animals shall be acclimatized to the laboratory conditions for at least five days prior to testing.
5.5 The nictitating membrane should not be removed from the rabbits’ eyes, and the eyelids should not be sutured during lens wear. Any deviations shall be justified and documented in the test report.
NOTE The albino rabbit eye is free of pigment, easily examined and has historically been used for ocular irritation studies. All appropriate regulatory requirements governing the care and use of animals shall be followed.
5.6 During daily treatment, the rabbits shall be minimally restrained.
6 Reagents/materials
6.1 Sodium fluorescein, as specified by an appropriate pharmacopoeia.
NOTE Attention should be made to the degree of staining and the concentration of fluorescein administered to the eye (e.g. 3 ul of 1 % fluorescein in saline solution).
6.2 Contact lens care products. as recommended by the manufacturers.
