Health Care Technology Official British Standard

BS EN ISO 11979-7:2018

Comprehensive standard for ophthalmic implants, covering design, materials, and testing requirements. Ensure compliance and patient safety with this essential resource.

Comprehensive Standard for Ophthalmic Implants

BS EN ISO 11979-7:2018 is the essential standard for anyone involved in the design, manufacture, or use of ophthalmic implants. This comprehensive document outlines the detailed requirements and test methods for a wide range of implantable devices, from intraocular lenses to corneal implants.

Ensure Compliance and Patient Safety

Compliance with this standard is crucial for manufacturers and healthcare providers to ensure the safety and efficacy of ophthalmic implants. The standard covers:

  • Design and material requirements for implants
  • Biocompatibility and toxicological testing
  • Mechanical, physical, and optical performance testing
  • Sterilization and packaging requirements
  • Labeling and information to be supplied by the manufacturer

By adhering to the guidelines set forth in BS EN ISO 11979-7:2018, you can be confident that your ophthalmic implants meet the highest standards of quality and safety, protecting both patients and healthcare providers.

Comprehensive Guidance for Ophthalmic Implants

This standard is an essential resource for a wide range of stakeholders, including:

  • Manufacturers: Ensure your ophthalmic implants meet all design, material, and testing requirements for regulatory approval and patient safety.
  • Healthcare Providers: Rely on this standard to evaluate the suitability and safety of ophthalmic implants for your patients.
  • Researchers and Developers: Use this standard as a reference for developing new and innovative ophthalmic implants that meet the industry's highest standards.

Key Features and Benefits

  • Comprehensive Coverage: Addresses a wide range of ophthalmic implants, including intraocular lenses, corneal implants, and other devices.
  • Detailed Requirements: Outlines specific design, material, and testing criteria to ensure the safety and performance of ophthalmic implants.
  • Regulatory Compliance: Adherence to this standard can help manufacturers and healthcare providers meet regulatory requirements and ensure patient safety.
  • Authoritative Guidance: Developed by experts in the field, this standard provides reliable and up-to-date information on the latest industry best practices.

Whether you're a manufacturer, healthcare provider, or researcher, BS EN ISO 11979-7:2018 is an essential resource for ensuring the safety and efficacy of ophthalmic implants. Invest in this standard today and take the first step towards delivering the highest quality of care to your patients.

Technical Information

Health Care Technology
BSI Group
978 0 580 93046 1
Specification Details
  • Ophthalmic implants
  • Intraocular lenses - Clinical investigations of intraocular lenses for the correction of aphakia
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