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Homepage>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.70 Ophthalmic equipment>BS EN ISO 11980:2025 Ophthalmic optics. Contact lenses and contact lens care products. Requirements and guidance for clinical investigations
immediate downloadReleased: 2025-07-17
BS EN ISO 11980:2025 Ophthalmic optics. Contact lenses and contact lens care products. Requirements and guidance for clinical investigations

BS EN ISO 11980:2025

Ophthalmic optics. Contact lenses and contact lens care products. Requirements and guidance for clinical investigations

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Standard number:BS EN ISO 11980:2025
Pages:40
Released:2025-07-17
ISBN:978 0 539 24586 8
Status:Standard
Pages (English):40
ISBN (English):978 0 539 24586 8

BS EN ISO 11980:2025 - Ophthalmic Optics: A Comprehensive Guide to Contact Lenses and Care Products

Welcome to the future of ophthalmic optics with the BS EN ISO 11980:2025 standard. This essential document is a cornerstone for professionals in the field of eye care, providing a detailed framework for the clinical investigation of contact lenses and their care products. Released on July 17, 2025, this standard is the latest in a series of updates that ensure the highest quality and safety in ophthalmic products.

Key Features of BS EN ISO 11980:2025

  • Standard Number: BS EN ISO 11980:2025
  • Pages: 40
  • ISBN: 978 0 539 24586 8
  • Status: Standard

This standard is meticulously crafted to guide manufacturers, researchers, and healthcare professionals through the complexities of clinical investigations related to contact lenses and their care products. With 40 pages of in-depth information, it serves as a comprehensive resource for ensuring compliance with international safety and quality benchmarks.

Why Choose BS EN ISO 11980:2025?

The BS EN ISO 11980:2025 standard is not just a document; it is a commitment to excellence in eye care. Here’s why it stands out:

1. Comprehensive Coverage

This standard covers a wide range of topics essential for the development and testing of contact lenses and care products. It includes detailed requirements and guidance for conducting clinical investigations, ensuring that all aspects of product safety and efficacy are thoroughly evaluated.

2. Up-to-Date Information

Released in 2025, this standard incorporates the latest advancements and research in ophthalmic optics. It reflects current best practices and technological innovations, making it an indispensable tool for staying ahead in the field.

3. International Recognition

As part of the ISO (International Organization for Standardization) family, this standard is recognized globally. It facilitates international trade and cooperation by providing a common framework that is accepted and respected worldwide.

4. Enhanced Patient Safety

Patient safety is at the heart of the BS EN ISO 11980:2025 standard. By adhering to its guidelines, manufacturers and healthcare providers can ensure that their products meet the highest safety standards, thereby protecting patients and enhancing their quality of life.

Who Should Use This Standard?

The BS EN ISO 11980:2025 standard is designed for a wide audience, including:

  • Manufacturers: Companies involved in the production of contact lenses and care products will find this standard invaluable for ensuring their products meet international safety and quality standards.
  • Researchers: Those conducting clinical investigations will benefit from the detailed guidance provided, ensuring their studies are robust and compliant with global standards.
  • Healthcare Professionals: Optometrists, ophthalmologists, and other eye care professionals can use this standard to stay informed about the latest requirements and best practices in the field.

Structure and Content

The BS EN ISO 11980:2025 standard is structured to provide clear and concise information, making it easy to navigate and understand. It includes sections on:

  • General Requirements: An overview of the fundamental requirements for contact lenses and care products.
  • Clinical Investigation Guidelines: Detailed instructions on how to conduct clinical investigations, including study design, data collection, and analysis.
  • Safety and Efficacy: Criteria for evaluating the safety and effectiveness of products.
  • Quality Assurance: Guidelines for maintaining high standards of quality throughout the product lifecycle.

Conclusion

The BS EN ISO 11980:2025 standard is an essential resource for anyone involved in the field of ophthalmic optics. Its comprehensive coverage, up-to-date information, and international recognition make it a vital tool for ensuring the safety and quality of contact lenses and care products. By adhering to this standard, professionals can contribute to the advancement of eye care and the well-being of patients worldwide.

Embrace the future of ophthalmic optics with the BS EN ISO 11980:2025 standard and ensure your products and practices are aligned with the highest international standards.

DESCRIPTION

BS EN ISO 11980:2025


This standard BS EN ISO 11980:2025 Ophthalmic optics. Contact lenses and contact lens care products. Requirements and guidance for clinical investigations is classified in these ICS categories:
  • 11.040.70 Ophthalmic equipment
This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products. NOTE 1        This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document. NOTE 2        For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).