Overview
ISO 15752:2010 - "Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety" specifies optical radiation safety requirements and test methods for endoilluminator light sources and fibre‑optic endoilluminator light guides used to illuminate the interior of the eye during ocular surgery. This second edition (2010) defines classification, measurement procedures, manufacturer information and marking needed to manage retinal light‑hazard risks for endoilluminators.
Key topics and technical requirements
- Scope and classification
- Applies to endoilluminator light sources and light guides; instruments are classified as Group 1 (no potential light hazard) or Group 2 (potential light hazard) following ISO 15004-2:2007 definitions.
- Retinal protection
- If the aphakic‑weighted retinal exposure guideline is reached in under 30 minutes at maximum output, an integral retinal protection means is required, with its enabled/disabled status clearly evident to the user.
- Stability
- Devices must be designed so ageing, maintenance or correct component replacement do not reduce safe exposure times below rated levels during the product lifetime.
- Measurement and test methods
- Determination of irradiance, spectral irradiance and spectrally weighted irradiance for different light‑guide types (standard/collimated, wide‑angle/diffusing, chandelier, pic/forceps).
- Typical measurement distances: 15 mm for standard/collimated; 18 mm for wide‑angle/chandelier; 1 mm for pic/forceps (or manufacturer‑specified distances).
- Measurements are made in water or saline; apertures and averaging areas (e.g., 1 mm diameter or 0.03 mm for non‑uniform beams) are specified.
- Half‑angle (output divergence) measurement defined as the angle where irradiance equals half the maximum, with uncertainty
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