Overview
EN ISO 9394:2012 - Ophthalmic optics: Contact lenses and contact lens care products - specifies an in vivo ocular study using rabbit eyes to determine biocompatibility and the degree of ocular irritation caused by contact lens materials and care products. The standard describes test design, animal husbandry, examination procedures (slit‑lamp, fluorescein staining), histology and data reporting. It is intended to support safety evaluation within a device risk‑management program and to be used in conjunction with relevant biological evaluation standards.
Key topics and technical requirements
- Test method: In vivo ocular exposure of contact lenses or lens care–treated lenses on rabbit eyes to evaluate irritation and tolerance.
- Animals and husbandry: Typically New Zealand white or equivalent albino rabbits, healthy young adults, >2.5 kg; minimum of three rabbits (six recommended); individual housing and identification; acclimatization and welfare in accordance with ISO 10993‑2.
- Good practice: Studies conducted under GLP/ISO/IEC 17025 and OECD GLP principles; qualified personnel perform assessments.
- Specimen preparation: Lenses selected to represent human use extremes or product line extremes, ensuring adequate fit to rabbit eye; lenses prepared and handled per manufacturer and care‑product instructions.
- Examinations and measurements:
- Slit‑lamp microscopy (with filters) and magnification for anterior eye assessment.
- Fluorescein staining to detect corneal epithelial damage.
- Body weight monitoring, histological examination and optional corneal metabolism assays.
- Use of standardized scoring systems (e.g., McDonald‑Shadduck, Draize scale) for lesion/irritation grading (annexes in the standard).
- Controls and reporting: Contra‑lateral eye or matched control group recommended; positive controls discouraged. Detailed test report required documenting lens parameters, procedures, observations and conclusions.
Practical applications
- Safety assessment of novel contact lens materials, coatings and contact lens care products (cleaners, disinfectants, solutions) prior to clinical use.
- Generating regulatory and technical evidence for manufacturers, test laboratories and regulatory submissions.
- Supporting product development decisions (material selection, formulation changes) and post‑market safety investigations.
Who uses this standard
- Contact lens and ophthalmic product manufacturers
- Contract testing laboratories and GLP facilities
- Regulatory affairs and quality assurance teams
- Researchers conducting preclinical ocular safety studies
Related standards
EN ISO 9394:2012 provides a standardized, documented approach for in vivo ocular biocompatibility testing, helping ensure reproducible safety data for contact lenses and lens care products while emphasizing animal welfare and regulatory compliance.
