BS EN ISO 11979-4:2008+A1:2012

Overview

BS EN ISO 11979-4:2008+A1:2012 is a crucial standard within the health care technology sector, specifically focusing on ophthalmic implants, particularly intraocular lenses (IOLs). This standard outlines the requirements for labelling and information that must accompany these devices. The standard aims to ensure that all relevant information is provided to health care professionals and patients, thereby enhancing safety and efficacy in the use of intraocular lenses.

Key Requirements

The standard sets forth specific requirements regarding the labelling and accompanying information for intraocular lenses. Key aspects include:

• Clarity and Comprehensiveness: Labels must be clear and provide comprehensive information about the product, including its intended use, specifications, and any potential risks.
• Compliance with Regulatory Frameworks: The labelling must comply with relevant European regulations and directives, ensuring that all necessary information is accessible to users.
• Language Requirements: Information must be provided in a language that is understandable to the intended users, ensuring effective communication of critical information.
• Traceability: The labelling must include unique identifiers that facilitate traceability of the product throughout its lifecycle.

Implementation Benefits

Adhering to BS EN ISO 11979-4:2008+A1:2012 offers several practical benefits for manufacturers and healthcare providers:

• Enhanced Patient Safety: By providing clear and comprehensive labelling, patients are better informed about their devices, which can lead to improved outcomes and reduced risk of complications.
• Improved Compliance: Compliance with this standard helps manufacturers meet regulatory requirements, reducing the risk of penalties or product recalls.
• Market Confidence: Compliance with recognised standards can enhance the reputation of manufacturers, fostering trust among healthcare professionals and patients.
• Facilitated Training: Clear labelling aids healthcare professionals in training and educating patients about the use and care of intraocular lenses.

Compliance Value

Compliance with BS EN ISO 11979-4:2008+A1:2012 is not merely a regulatory obligation; it is a commitment to quality and safety in healthcare technology. This standard provides a framework that helps ensure:

• Regulatory Alignment: Meeting the requirements of this standard aligns with broader regulatory frameworks, facilitating market access across Europe.
• Risk Management: By adhering to the labelling requirements, manufacturers can better manage risks associated with product use, thereby enhancing overall product safety.
• Continuous Improvement: The standard encourages ongoing evaluation and improvement of labelling practices, fostering innovation and better patient outcomes.

In conclusion, BS EN ISO 11979-4:2008+A1:2012 serves as a vital reference for manufacturers of intraocular lenses, ensuring that labelling and information provided are not only compliant but also enhance patient safety and care. By implementing the requirements set forth in this standard, manufacturers can demonstrate their commitment to quality and patient welfare.