This part of ISO 11979 specifies specific requirements for the assessment of biocompatibility of materials for intraocular lenses, including the processing conditions to manufacture them. These requirements include evaluation of physicochemical properties related to biocompatibility. It also provides guidance on performing ocular implantation testing.
The following physicochemical tests will be considered:
In addition, the risk assessment will include an assessment of possible significant changes, such as calcification. This risk assessment should consider the material's clinical use history and animal models to test the material's long-term stability.
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