Overview
EN ISO 12867:2010 - Ophthalmic instruments: Trial frames specifies minimum requirements and type test methods for trial frames used to hold trial case lenses (ISO 9801) in front of a subject’s eyes to assess visual acuity and facilitate optical correction. Applicable to headband-mounted, bracket-mounted and spectacle-style frames (including half‑eye and rotating lens holders), this European adoption of ISO 12867:2010 takes precedence over ISO 15004‑1 where differences occur.
Key topics and technical requirements
- Scope and purpose: Defines mechanical, dimensional and material requirements and required documentation for trial frames used in clinical refraction.
- Lens holder design: Each frame must position one lens holder per eye and retain combinations of at least three lenses in separate compartments along the optical axis.
- Interpupillary distance (IPD): Adjustable spacing; typical ranges given:
- Full/reduced-aperture: 55 mm to 75 mm
- Half‑eye: 59 mm to 67 mm
- Aperture and rotation:
- Minimum clear aperture: 20 mm
- Minimum lens rotation: 180°
- Alignment and tolerances:
- Geometrical axes of lens holders parallel within 2°
- Relative axial displacement ≤ 0.5 mm
- When fitted with ISO 9801 lenses, lens axes parallel within 2.5°, centring within a 1 mm diameter tolerance; lenses must not move laterally/axially more than 0.2 mm.
- Adjustment features: Vertex distance and lens height relative to the interpupillary line must be adjustable (bridge piece).
- Materials and safety:
- Skin-contact components must be non‑toxic and not prone to causing significant allergic reactions.
- Materials must be non‑corrosive or suitably treated for clinical conditions.
- No sharp edges or hazardous surfaces.
- Marking and documentation:
- Permanent manufacturer/supplier name.
- Instructions for use must include manufacturer contact, disinfection guidance, model ID and reference to ISO 12867:2010 if claimed.
- Test methods:
- All tests are type tests. Annex A gives examples (autocollimation telescope and laser methods) for checking parallelism and plane coincidence.
Applications and users
- Intended for trial frame manufacturers, quality and compliance teams, test laboratories, ophthalmic instrument designers, regulatory bodies and eye‑care clinics that procure or validate trial frames.
- Useful for ensuring product safety, interchangeability with ISO 9801 trial case lenses, and standardised clinical refraction practice.
Related standards
Keywords: EN ISO 12867:2010, trial frames, ophthalmic instruments, trial case lenses, interpupillary distance, lens holders, test methods, ISO 9801.
