Overview
EN ISO 15752:2010 (adoption of ISO 15752:2010) defines optical radiation safety requirements and test methods for endoilluminators - the light sources and fibre-optic light guides used to illuminate the interior of the eye during ocular surgery. Published by CEN/ISO, the standard focuses on protecting the retina and ensuring consistent, demonstrable safety performance for ophthalmic instruments that deliver intraocular light.
Key topics and technical requirements
- Scope and classification
- Applies to endoilluminator light sources and endoilluminator light guides used in ocular surgery.
- Instruments are classified as Group 1 (no potential light hazard) or Group 2 (potential light hazard) in accordance with ISO 15004-2:2007.
- Retinal protection
- If the time to reach the aphakic-weighted retinal radiant exposure guideline is under 30 minutes at maximum output, a retinal protection means must be provided to extend exposure time ≥ 30 min. Status (enabled/disabled) must be clearly indicated to the user.
- Stability of light intensity
- The light source must maintain safe output over its lifetime under correct maintenance, so ageing or component replacement does not reduce safe exposure times below stated limits.
- Test methods
- Measurement of irradiance, spectral irradiance and spectrally weighted irradiance for different light-guide types (standard/collimated, wide-angle/diffusing, chandelier, pic/forceps).
- Specified measurement distances and averaging areas (examples: 15 mm for standard/collimated, 18 mm for wide-angle/chandelier, 1 mm for pic tips) and measurement in water or saline solution.
- Determination of output divergence half-angle (angle where irradiance = half the maximum), with angular uncertainty