BS EN ISO 11979-8:2017 Ophthalmic Implants - Intraocular Lenses Fundamental Requirements

Discover the essential standard for ophthalmic implants with the BS EN ISO 11979-8:2017. This comprehensive document outlines the fundamental requirements for intraocular lenses, ensuring that they meet the highest standards of quality and safety. Released on March 30, 2020, this standard is a must-have for professionals in the field of ophthalmology and medical device manufacturing.

Key Features

• Standard Number: BS EN ISO 11979-8:2017
• Pages: 14
• Release Date: March 30, 2020
• ISBN: 978 0 539 13461 2
• Status: Standard

Overview

The BS EN ISO 11979-8:2017 standard is a critical document for anyone involved in the design, production, or regulation of intraocular lenses. It provides a detailed framework for the fundamental requirements that these medical devices must meet to ensure they are safe and effective for use in ophthalmic procedures.

Why This Standard is Important

Intraocular lenses are a vital component in the treatment of various eye conditions, including cataracts and refractive errors. As such, it is crucial that these lenses adhere to stringent quality and safety standards. The BS EN ISO 11979-8:2017 standard provides the necessary guidelines to ensure that intraocular lenses are manufactured to the highest standards, minimizing risks and enhancing patient outcomes.

Comprehensive Coverage

With 14 pages of detailed information, this standard covers a wide range of topics related to intraocular lenses. It includes specifications for materials, design, performance, and testing, ensuring that all aspects of lens production are addressed. This comprehensive approach helps manufacturers produce lenses that are not only safe but also effective in improving vision.

Who Should Use This Standard?

The BS EN ISO 11979-8:2017 standard is essential for a variety of professionals, including:

• Ophthalmologists and eye care specialists who need to understand the quality and safety standards of the lenses they use.
• Medical device manufacturers involved in the production of intraocular lenses.
• Regulatory bodies responsible for ensuring the safety and efficacy of medical devices.
• Quality assurance professionals who oversee the compliance of medical devices with international standards.

Benefits of Compliance

Adhering to the BS EN ISO 11979-8:2017 standard offers numerous benefits, including:

• Enhanced Safety: By following the guidelines set out in this standard, manufacturers can ensure that their lenses are safe for use, reducing the risk of complications during and after surgery.
• Improved Quality: The standard provides a framework for producing high-quality lenses that meet the needs of patients and healthcare providers.
• Regulatory Compliance: Compliance with this standard helps manufacturers meet regulatory requirements, facilitating market access and reducing the risk of product recalls.
• Increased Trust: By adhering to internationally recognized standards, manufacturers can build trust with healthcare providers and patients, enhancing their reputation in the market.

Conclusion

The BS EN ISO 11979-8:2017 standard is an indispensable resource for anyone involved in the field of ophthalmic implants. By providing clear and comprehensive guidelines for the production of intraocular lenses, it ensures that these critical medical devices meet the highest standards of quality and safety. Whether you are a manufacturer, healthcare provider, or regulatory body, this standard is essential for ensuring the best possible outcomes for patients.

BS EN ISO 11979-8:2017

This standard BS EN ISO 11979-8:2017 Ophthalmic implants. Intraocular lenses is classified in these ICS categories:

• 11.040.70 Ophthalmic equipment