BS EN ISO 11985:1998

Overview

BS EN ISO 11985:1998 is a critical standard in the field of health care technology, specifically concerning ophthalmic optics. This standard outlines the in vitro method for assessing the ageing of contact lenses when exposed to ultraviolet (UV) and visible radiation. The longevity and safety of contact lenses are paramount for user health, making this standard essential for manufacturers and compliance professionals in the optical industry.

Key Requirements

The standard specifies a systematic approach for testing contact lenses under controlled conditions that simulate real-world exposure to UV and visible light. Key requirements include:

• Test Methodology: Detailed procedures for exposing contact lenses to UV and visible radiation.
• Assessment Criteria: Guidelines for evaluating the physical and optical properties of lenses post-exposure.
• Documentation: Requirements for recording and reporting test results to ensure traceability and accountability.

Implementation Benefits

Adhering to BS EN ISO 11985:1998 offers several practical benefits for manufacturers and stakeholders:

• Quality Assurance: Ensures that products meet stringent safety and performance criteria, thereby enhancing consumer trust.
• Market Access: Compliance with this standard can facilitate entry into various markets, as it demonstrates adherence to internationally recognised safety protocols.
• Risk Mitigation: Reduces the risk of product failure and associated liabilities by ensuring thorough testing of contact lenses.

Compliance Value

Compliance with BS EN ISO 11985:1998 is not merely a regulatory requirement; it is a strategic advantage. By following this standard, manufacturers can:

• Enhance Reputation: Establish a reputation for quality and safety in the competitive optical market.
• Meet Regulatory Obligations: Ensure compliance with national and international regulations governing medical devices.
• Support Innovation: Foster an environment for innovation by providing a clear framework for testing and validation.

In conclusion, BS EN ISO 11985:1998 serves as a foundational standard for the assessment of contact lenses under UV and visible radiation exposure. Its implementation not only ensures product safety and efficacy but also enhances the overall quality of care provided to users. Compliance professionals should prioritise this standard to maintain high industry standards and safeguard consumer health.