ISO 9394-2012 pdf free download

ISO 9394-2012 pdf free download.Ophthalmic optics Contact lenses and contact lens care products Determination of biocompatibility by ocular study with rabbit eyes
Optique ophtalmique — Lentilles de contact et produits d’entretien pour lentilles de contact — Determination de Ia biocompatibilité par evaluation de Ia tolerance oculaire chez le lapin.
7.3 Balance or weighing machine, capable of weighing up to 5 kg to an accuracy of 100 g.
8 Test specimens
8.1 Lens parameters
Contact lenses shall be sufficiently thick to represent either
a) reasonable human use extremes; or
b) the extreme of the manufacturer’s product line.
The contact lens selected shall produce a good fit to a rabbit eye.
NOTE This is necessary to minimize physical irritabon and expulsion. In the case where this thickness does not allow a good fit of the contact lens, a contact lens of the greatest thickness which allows a good fit should be used. Contact lens parameters shall be documented in the final report.
8.2 Preparation and storage
If contact lens care products are to be used in the evaluation, lenses shall be prepared, cleaned, disinfected, stored and rinsed according to the lens manufacturer’s instructions using contact lens care products (6.2). If a lens falls out during the daily treatment period, it shall be rinsed with rinsing solution (6.2) and re-inserted into the rabbit’s eye from which it has fallen out.
NOTE 1 Sufficient additional lenses should be treated using at least one complete day lens care treatment to replace any lenses that are damaged or lost during the lens-wear day.
NOTE 2 Hydrogel lenses which Cannot be immediately reinserted because of drying should be swapped for a similar lens which has been treated in line with the manufacturer’s recommendations, Hydrogel lenses which have dried out may be re-used once cleaned and/or rehydrated.
Before insertion, contact lenses should be checked for particulate matter, physical damage and, during hydrogel lens use, for lens inversion. While inserting contact lenses, rabbits shall be observed for reactions different to that during the insertion of a control lens. Such reactions shall be recorded.
Contact lenses shall not be intermixed between rabbits in the same treatment group. If applicable, lens storage cases shall not be intermixed between treatment groups.
For evaluation of contact lens care products, for example multipurpose solutions, testing with representative conventional and silicone hydrogel lenses should be conducted with the lens care product. The choice of lenses should be justified.ISO 9394-2012 pdf free download.