ISO 11979-3 Ophthalmic Implants, Intraocular Lenses, Part 3: Mechanical Properties and Test Methods

Medical Tests

ISO 11979-3 Ophthalmic Implants, Intraocular Lenses, Part 3: Mechanical Properties and Test Methods

EUROLAB laboratory provides testing and compliance services within the scope of ISO 11979-3 standard. This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs).

ISO 11979-3 Ophthalmic Implants, Intraocular Lenses, Part 3: Mechanical Properties and Test Methods

It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, with the exception of corneal implants, provided that the test method complies with the relevant IOL design.

Mechanical properties for all IOLs will be determined in situ. The exact composition of the solution used should in any case be reported. If a justification for the in situ deviation is given, alternative test conditions, room temperature conditions, may be used. Alternative test conditions will be specified in test reports.

If the dioptric power affects the property under test, the batches will consist of low, medium and high dioptric powers. For toric intraocular lenses, half of each of these three lots should contain the intraocular lenses with the highest cylindrical power, and the other half should contain the intraocular lenses with the lowest cylindrical power.

The minimum sample size for each test will be 10 IOLs per lot. Batches must represent marketed IOLs. In all cases, the sampling criteria applied will be reported. Means and standard deviations for pooled samples will be reported.

If a particular test method described in this section of ISO 11979 cannot be applied for particular designs and particular applications, the IOL manufacturer may design a relevant test method and provide justification and justification for it.

EUROLAB assists manufacturers with ISO 11979-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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