Overview
SIST EN ISO 11981:2018 is an international standard developed by CEN and ISO for the assessment of the physical compatibility between contact lens care products and contact lenses. Its procedures enable manufacturers, laboratories, and regulatory bodies to evaluate whether contact lens care solutions and products may induce physical changes-such as alterations in diameter, power, or surface appearance-in contact lenses, and to determine if these changes are reversible. This standard is vital for maintaining lens performance, wearer safety, and ensuring compliance in the ophthalmic industry.
Key Topics
- Physical Compatibility Assessment: SIST EN ISO 11981:2018 outlines general procedures for assessing if a contact lens care product physically alters contact lenses during typical use cycles.
- Detection of Changes: It provides guidance on identifying changes in lens characteristics, such as diameter, curvature, power, and surface properties, using standardized test methods.
- Reversible vs. Irreversible Changes: The standard defines a method to determine whether observed changes in contact lenses are reversible (after returning lenses to saline solution) or irreversible.
- Material Coverage: Testing must cover various lens materials, including hydrogel and non-hydrogel lenses, ensuring products are suitable across types as described in ISO 18369-1.
- Test Reporting: Requirements for thorough documentation of test results, procedures, involved products, and laboratory information.
Applications
SIST EN ISO 11981:2018 is used across the ophthalmic optics sector, including by:
- Contact Lens and Care Product Manufacturers: To demonstrate product compatibility, satisfy regulatory requirements, and support product development.
- Testing Laboratories: To conduct objective, standardized assessments of lens care product safety and effectiveness.
- Conformity Assessment and Regulatory Compliance: Ensuring products entering the market do not adversely affect contact lens parameters, safeguarding wearer health and upholding trust in the industry.
- Research and Development: Providing standard protocols for evaluating new formulations or lens materials.
Compliance with SIST EN ISO 11981:2018 helps companies avoid product recalls, customer complaints, and regulatory penalties by proactively verifying that cleaning solutions, disinfectants, or rewetting drops do not cause unintended, potentially harmful changes to contact lenses during use.
Related Standards
SIST EN ISO 11981:2018 references several key standards for specific test methods, material categorization, and control solutions, including:
- ISO 18369-1: Vocabulary, classification system, and labeling recommendations for contact lenses.
- ISO 18369-2: Tolerances for contact lenses, critical in evaluating permissible changes in physical characteristics.
- ISO 18369-3: Standardized measurement methods for contact lens properties.
- ISO 18259: Methodology for assessing contact lens care products' antimicrobial efficacy.
- ISO 18369-4: Focused on the physicochemical properties of contact lens materials.
By adhering to the protocols and referencing the supporting standards, ophthalmic product developers and laboratories ensure consistency, repeatability, and internationally recognized quality in their compatibility testing.
For those working with contact lens care products and seeking to maintain compliance and safety, SIST EN ISO 11981:2018 provides a robust, internationally recognized framework for ensuring physical compatibility with a wide range of contact lenses.