Overview
ISO 18369-4:2017 - Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials - defines standardized test methods for measuring the key physicochemical characteristics of contact lens materials. The standard covers extractables, rigid lens flexure and breakage, oxygen permeability (Dk), refractive index, and water content, and specifies apparatus, reagents, procedures and reporting requirements used by testing laboratories, manufacturers and suppliers.
Key topics and technical requirements
Practical applications and who uses this standard
- Contact lens manufacturers and material suppliers - for material characterization during development and quality control.
- Testing laboratories and QC facilities - to perform standardized measurements for compliance, product release and comparative studies.
- Regulatory affairs and conformity assessment - to substantiate product safety and performance claims with standardized test data.
- R&D teams and clinicians - when evaluating new materials or comparing material properties relevant to ocular physiology (oxygen transmission, hydration, optical properties).
Related standards
- ISO 18369-1:2017 - Vocabulary, classification system and labelling recommendations for contact lenses.
- ISO 18369-3:2017 - Measurement methods (related measurement procedures).
- ISO 3696 - Water for analytical laboratory use (referred for reagent quality).
Keywords: ISO 18369-4:2017, contact lens materials, physicochemical properties, oxygen permeability, Dk, extractables, refractive index, water content, Soxhlet extraction, polarographic method.