The ISO 11979 standard defines the global framework for evaluating the safety, performance, and durability of intraocular lenses (IOLs) and related ophthalmic devices. From hydrolytic stability to mechanical strength and optical performance, these tests ensure devices meet the highest expectations of both regulators and patients. At Invision Biomedical, we deliver comprehensive ISO 11979 testing that aligns with FDA and CE requirements—helping manufacturers achieve compliance while building confidence in their products.
Clarity and function are critical to intraocular lenses. ISO 11979-2 outlines optical testing to confirm that lenses meet performance expectations, ensuring patients receive devices that restore vision without compromise.
InVision employs the OptiSpheric IOL Pro 2 Optical Bench for optical performance evaluations.
Intraocular lens (IOL) mechanical requirements from ISO 11979-3 include dynamic fatigue durability, haptic compression force, decentration, tilt, etc., to assure long-term performance of the implant. InVision is certified to perform the complete ISO mechanical suite of tests under in situ conditions, i.e., immersed in aqueous medium at 35C.
Long-term exposure to aqueous environments and UV light can affect lens materials. Hydrolytic stability and photostability studies simulate these conditions, verifying that ophthalmic devices maintain their integrity and effectiveness over years of use.
Intraocular lenses, glaucoma shunts, and artificial corneas are all biomedical implants and so regulatory approvals of these devices require E&L testing. InVision has extensive history and unique knowledge and capabilities to perform E&L studies that are compliant with ISO 10993 and ISO 11979. In fact, our E&L studies have facilitated the approval of more than 40 ophthalmic devices for our clients over the past 25 years!
Months or even years after intraocular lens (IOL) implantation a hazing known as posterior capsular opacification (PCO) can occur resulting in a reduction in visual acuity. PCO is typically corrected by using Nd:YAG laser pulses to poke a hole in the posterior capsule clearing away the opacified tissue. ISO 11979-5 requires evaluation of cytotoxic potential of direct hits on the implanted IOL. We use our in-house laser system custom mounting fixtures to simulate the Nd:YAG procedure and to prepare supernatants for cytotoxicity screening.
ISO 11979 is the international standard for intraocular lenses and related ophthalmic devices. It provides detailed test requirements that prove a device is safe, effective, and durable, making it essential for global regulatory approvals.
ISO 11979 covers a wide range of evaluations, including optical performance, hydrolytic and photo stability, mechanical performance, and extractables and leachables studies. Each test confirms that devices meet patient safety and quality benchmarks.
For E&L and stability, testing involves exposing device materials to extraction solvents under controlled, often exaggerated conditions. Extracted compounds are identified and quantitated using advanced techniques such as LC/MS, GC/MS, and ICP-MS. Comprehensive summaries of extracted compounds are provided to certified toxicology experts for what are known as “Toxicological Risk Assessments” which are conducted to assure the safety of the implanted devices.
