BS EN ISO 11979-5:2006 follows the general principles given in ISO 10993-1. ISO 10993-1 and describes the principles governing the biological evaluation of medical devices, the definitions of categories based on the nature and duration of contact with the body, and selection of appropriate tests. Other parts of BS EN ISO 10993 present biological test methods, tests for ethylene oxide residues, tests for degradation and principles for sample preparation.
This standard specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
BS EN ISO 11979-5:2006 replaces BS EN 13503-5:2001, which has been withdrawn.
