ISO TR 22979 provides guidance on the application of parts 11979, 3 and 7 of the ISO 9 International series of standards for intraocular lenses (IOLs). It addresses factors to consider in a risk analysis of the significance of changes in anterior and posterior chamber, monofocal and multifocal, intraocular lenses. It also recommends data analysis and interpretation methods that can be used to determine the design and need for a clinical trial.
This standard provides risk assessment considerations to determine the clinical research effort needed based on the level of change defined in it.
Design changes to base model IOLs are classified as level A, B, or C. Examples of design-related risks on classification, identified safety and performance risks are provided in the modifications.
EUROLAB assists manufacturers with ISO TR 22979 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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