EN ISO 11986:2026 PDF

Overview

EN ISO 11986:2026 specifies general procedures for determining the uptake and release of preservatives from contact lenses and contact lens care products. Developed by the European Committee for Standardization (CEN) in collaboration with ISO, this international standard supports the safe development of new contact lens materials and care solutions by providing a consistent approach for preservative testing.

The procedures outlined in EN ISO 11986:2026 are not intended for routine testing of production batches or for establishing final product specifications. Instead, they are used during the research and development phase to characterize new or modified contact lens materials and lens care products. Notably, these test methods are only suitable for new and unused lenses, acknowledging the challenges in reproducing results with worn lenses due to deposits acquired during use.

Key Topics

• Scope and Purpose

  • Focused on providing general guidance for the selection of analytical methods, sample preparation, and test execution.
  • Designed solely for use in development and characterization of new/modified contact lens materials or solutions, not for routine quality control.

• Test Procedures

  • Immersion of contact lenses in test solutions at controlled temperatures for analysis of preservative absorption.
  • Subsequent extraction of lenses into saline solution to quantify preservative release over defined time intervals.
  • Requirements for test design, including adequate detection limits, repeatability, and reproducibility.

• Sample and Method Selection

  • Emphasizes the importance of choosing material and product samples representative of intended application (e.g., hydrogel, silicone hydrogel, or rigid gas-permeable lenses).
  • Justification required for test lenses and care products used, ensuring relevance to potential use scenarios.

• Result Reporting

  • Instruction on expressing results in micrograms per defined mass, lens, or surface area.
  • Emphasis on detailed documentation, including test conditions, materials, analytical procedures, and deviations.

Applications

• Research and Development

  • Applied during the development of innovative contact lens materials or new formulations of lens care solutions by evaluating preservative interactions.
  • Assesses how much preservative can be absorbed from care products and subsequently released from the contact lens matrix.

• Safety and Toxicology Assessment

  • Results are essential for understanding the potential for preservatives to induce ocular sensitivity or toxicity, supporting product safety evaluations.

• Material Characterization

  • Helps classify contact lens materials based on their preservative uptake and release profiles, crucial for regulatory submissions or product claims.

• Regulatory Compliance

  • Aids manufacturers in conforming to international and European ophthalmic standards, bolstering product documentation and quality during the product development lifecycle.
  • Not designed to measure disinfection performance, nor to be used for routine product release testing.

Related Standards

• ISO 18369-1:2017 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications. Essential for classification and proper identification of lens materials.

• ISO 18369-3:2017 Ophthalmic optics - Contact lenses - Part 3: Measurement methods. Referenced for preparation of saline solutions and other analytical procedures.

• US FDA Guidance (Premarket Notification 510(k) for Contact Lens Care Products) Includes methodologies for preservative uptake/release analysis, harmonizing international regulatory expectations.

By following EN ISO 11986:2026, laboratories and manufacturers can reliably evaluate preservative-lens interactions and support the development of safer ophthalmic products, promoting innovation while adhering to recognized quality and safety standards across the contact lens industry.