BS EN ISO 11979-10:2018

Comprehensive Standard for Ophthalmic Implants

BS EN ISO 11979-10:2018 is the essential standard for manufacturers, suppliers, and healthcare providers working with ophthalmic implants. This comprehensive standard, identical to ISO 11979-10:2018, outlines the design, materials, and testing requirements for a wide range of intraocular lenses and other ophthalmic implants.

Ensure Compliance and Patient Safety

Compliance with BS EN ISO 11979-10:2018 is crucial for ensuring the safety and efficacy of ophthalmic implants. This standard provides detailed specifications and guidelines to help manufacturers and healthcare professionals navigate the complex regulatory landscape, minimizing risks and optimizing patient outcomes.

Key Features and Benefits

• Comprehensive Scope: Covers a wide range of ophthalmic implants, including intraocular lenses, corneal inlays, and other devices used in ophthalmology.
• Detailed Design Requirements: Specifies design criteria for materials, dimensions, optical properties, and other critical parameters to ensure optimal performance and safety.
• Rigorous Testing Protocols: Outlines comprehensive testing procedures for evaluating the mechanical, optical, and biological properties of ophthalmic implants, ensuring they meet the highest standards.
• Harmonized with International Standards: Aligned with the latest ISO standards, ensuring global consistency and facilitating international trade and regulatory compliance.
• Supports Innovation: Provides a framework for the development and evaluation of new ophthalmic implant technologies, fostering innovation and advancements in the field.

Comprehensive Guidance for Ophthalmic Implant Manufacturers

BS EN ISO 11979-10:2018 is an essential resource for manufacturers of ophthalmic implants, offering detailed guidance on design, materials, and testing requirements. By following the specifications outlined in this standard, manufacturers can ensure their products meet the highest quality and safety standards, ultimately benefiting patients and healthcare providers.

Key Areas Covered:

• Design Criteria: Detailed requirements for materials, dimensions, optical properties, and other design parameters to ensure optimal performance and safety.
• Biocompatibility: Guidance on evaluating the biological compatibility of materials used in ophthalmic implants, minimizing the risk of adverse reactions.
• Mechanical Testing: Comprehensive protocols for assessing the mechanical properties of ophthalmic implants, including tensile strength, flexibility, and resistance to deformation.
• Optical Performance: Detailed testing procedures for evaluating the optical characteristics of intraocular lenses and other ophthalmic implants, ensuring consistent and reliable visual outcomes.
• Sterilization and Packaging: Guidance on the appropriate sterilization methods and packaging requirements to maintain the integrity and safety of ophthalmic implants.

By adhering to the specifications outlined in BS EN ISO 11979-10:2018, manufacturers can demonstrate their commitment to quality, safety, and regulatory compliance, ultimately enhancing patient trust and driving the continued advancement of ophthalmic implant technology.