ISO 11979-5:2020 pdf download – Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility
5.2 Physical/Chemical description The manufacturer shall provide a description of each of the components in the formulation to facilitate the interpretation of physical and chemical test results. For description of each component the manufacturer shall provide, if available: a) Name — Provide the chemical name and Chemical Abstracts Service (CAS) registry number; b) Structure formula — Provide the chemical structure and molecular formula; c) If the component material is derived from biological sources, the organism from which it is obtained shall be stated along with its source. For the finished polymer the manufacturer shall provide, if available: d) Structure formula — Provide the chemical structure and molecular formula. 5.3 Exhaustive extraction test The test material shall be tested for extractables under exhaustive extraction conditions in accordance with the method specified in Annex A. Alternative methods can be used, provided that they have been validated and are reflective of the current state of the art. The following shall be observed: a) The reasons for selecting each solvent shall be justified and documented. b) The test material shall be weighed before and after extraction and any change in mass shall be calculated. c) The extraction media shall be qualitatively and quantitatively analysed at the end of extraction for possible extractable components of the material, such as process contaminants, residual monomers, additives, and other extractable components. The results shall be evaluated to assess the risk for potentially harmful effects due to extractable components.
5.6 Photostability test Photostability testing shall be conducted in accordance with Annex D. The following shall be observed: a) There shall be no changes in appearance of the irradiated test material when compared with non- irradiated test material, such as bulk and surface defects induced by photo irradiation. b) No significant change shall be detected between the UV/Vis spectra, dioptric power and image quality of the test material exposed to UV radiation and controls receiving no radiation. c) The exposure medium shall be qualitatively and quantitatively analysed for any chemical entities after irradiation and compared to non-irradiated controls. d) Furthermore, when performing the testing for anterior chamber IOLs, it shall be shown that no significant change in mechanical properties of the irradiated test material has occurred when compared with non-irradiated test material.