scope:

Indicates the fundamental principles governing the biological evaluation of medial devices, the definition of categories based on the nature and duration of contact with the body, and selection of appropriate tests. Other parts of ISO 10993 present biological test methods, test for ethylene oxide results, tests for degradation and principles for sample preparation. This standard specifies the requirements for the biological evaluation of intraocular lenses (IOLs) and specifies appropriate test methods. It is applicable to a test material, as defined in 3.1, that is not already known to be biocompatible in intraocular applications.