ISO 15004-2:2024

Overview

ISO 15004-2:2024 - Ophthalmic instruments: Part 2 - Light hazard protection specifies fundamental requirements and test methods for optical radiation safety of ophthalmic instruments that direct light into or at the eye. Applicable to wavelengths from 250 nm to 2 500 nm, it covers diagnostic, illumination, measurement, imaging and alignment functions, and parts of surgical/therapeutic systems that emit non-therapeutic optical radiation. The standard classifies devices into Group 1 (non‑hazardous) and Group 2 (potentially hazardous) to guide design, testing and labelling.

Key topics and technical requirements

• Classification principles for Group 1 vs Group 2 instruments, with test procedures to assign devices to the correct group.
• Exposure limits and recommended maximum exposure (RME) values for multiple exposure types (continuous wave, pulsed, time‑limited, dose‑limited, scanning and instruments with multiple sources).
• Measurement and test methods, including spectral measurements, radiance/irradiance determination and pulse counting procedures to assess when RMEs are reached.
• Special cases: provisions for long‑term repetitive daily use (e.g., head‑mounted displays), dose‑limited and time‑limited instruments.
• Manufacturer information and marking requirements: accompanying documents, safety statements, radiation output labelling and guidance for end users.
• Normative and informative annexes: spectral weighting functions, recommended measurement instruments, example measurement methods for specific ophthalmic devices, and safety sign guidance.
• Relationship with other standards: when device‑specific ("vertical") standards contain different light‑hazard requirements, those take precedence. ISO 15004-1 is referenced for general requirements.

Practical applications and who uses this standard

• Medical device manufacturers (design and compliance teams) use ISO 15004-2 to design safe ophthalmic instruments and prepare technical documentation.
• Test laboratories and conformity assessors apply the specified measurement methods and classification tests for regulatory submissions.
• Regulatory bodies and notified bodies reference the standard for product approvals and safety reviews.
• Clinical engineers and hospital procurement use the classification and labelling guidance to evaluate device safety for intended clinical workflows.
• Researchers and product developers of new ophthalmic imaging, diagnostic or head‑mounted display systems rely on the standard to assess optical safety early in development.

Related standards

• ISO 15004-1 (General requirements for all ophthalmic instruments)
• Applicable device‑specific (vertical) IEC/ISO standards where they provide alternate light hazard requirements

ISO 15004-2:2024 is essential for ensuring optical radiation safety in ophthalmic devices, supporting consistent risk assessment, testing and clear communication of light‑hazard information to manufacturers, testers and clinicians. Keywords: ISO 15004-2:2024, ophthalmic instruments, light hazard protection, optical radiation safety, exposure limits, Group 1, Group 2, test methods.