What is ISO 11979‑5 about?
ISO 11979 discusses intraocular lenses for ophthalmic implants. ISO 11979‑5 outlines requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include the evaluation of physicochemical properties that are relevant to biocompatibility.
ISO 11979 also gives guidance on conducting an ocular implantation test.
Who is ISO 11979‑5 for?
ISO 11979‑5 on the biocompatibility of intraocular lenses is useful for:
- Manufacturers of Ophthalmic implants
- Test centres and researchers
- Regulatory authorities
- Ophthalmologists / surgeons
Why should you use ISO 11979‑5?
Biocompatibility is important when surgical procedures introduce foreign materials into living tissue. Biocompatible materials do not produce a toxic or immunological response when exposed to the body or bodily fluids.
ISO 11979‑5 guidelines help you with general requirements and physicochemical tests to determine the biocompatibility of intraocular lenses. These include the exhaustive extraction test, test for leaching, test for hydrolytic stability, photostability test, and the Nd-YAG laser exposure test. ISO 11979‑5 also provides biological tests. These include tests for cytotoxicity, tests for sensitization, tests for genotoxicity, test for local effects, and ocular implantation test. These tests help researchers to determine the biocompatibility of different materials that could be used for intraocular lenses.
What’s changed since the last update?
BS EN ISO 11979‑5:2020 supersedes ISO 11979‑5:2006, which is withdrawn. BS EN ISO 11979‑5:2020 has some technical changes with respect to ISO 11979‑5:2006. These includes:
- Correction and addition of references throughout the document
- Added more specific guidance on risk-based approach throughout the document
- Added requirement to use state of the art analytical methods
- Update of apparatus lists where applicable
- Clarification of test material in Tables 1 and 2, reference to ISO/TR 22979 when the IOL is a modification of a parent IOL and requirement for a biological evaluation plan added to Clause 4
