ISO 15004-2-2024 PDF

Full title and description

ISO 15004-2:2024 — Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection. This international standard specifies optical radiation safety requirements, classification and test methods for ophthalmic instruments that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes, and covers new and emerging ophthalmic instruments and relevant portions of therapeutic/surgical systems where they direct optical radiation toward the eye.

Abstract

Specifies fundamental requirements for optical radiation safety of ophthalmic instruments that deliver optical radiation into or at the eye (wavelength range covered: 250 nm to 2 500 nm). The document classifies instruments into Group 1 (no potential light hazard) and Group 2 (potential light hazard), defines terms, gives exposure limits and associated tables, and sets measurement and manufacturer information requirements; therapeutic radiation is generally outside its scope but guidance is provided where treatment beams strike non-target tissues.

General information

• Status: Published
• Publication date: 5 December 2024
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.70 Ophthalmic equipment
• Edition / version: Edition 2 (2024)
• Number of pages: 56

Core bibliographic and lifecycle details as published by ISO.

Scope

Applies to all ophthalmic instruments that direct optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes, including new and emerging devices; optical radiation is taken as wavelengths between 250 nm and 2 500 nm. The standard does not apply to therapeutic radiation as such, but provides guidance for assessment of non-target tissue exposure from therapeutic beams. Where instrument-specific (vertical) standards contain different light-hazard requirements, those vertical standards take precedence.

Key topics and requirements

• Classification of ophthalmic instruments into Group 1 (no potential light hazard) and Group 2 (potential light hazard) with criteria for classification.
• Defined terminology for radiometric quantities (irradiance, radiance, radiant exposure, pulse duration, maximum intensity, etc.).
• Exposure limits and recommended maximum exposures organized into tables covering photochemical and thermal mechanisms across 250–2 500 nm.
• Measurement and test methods for continuous and pulsed instruments, including guidance for pulse trains and time-averaged irradiance calculations.
• Requirements for manufacturer information, labeling and instructions addressing safe use, classification, test results and conditions of use.
• Special provisions for dose-limited and time-limited instruments, and notes on applicability where therapeutic beams affect non-target tissues.
• Statement that vertical/sector-specific standards override where they specify different light-hazard requirements.

These topics reflect the standard’s reorganized exposure-limit tables, expanded definitions (including dose/time limited instruments) and updated test guidance introduced in the 2024 revision.

Typical use and users

Manufacturers and designers of ophthalmic instruments (e.g., slit lamps, diagnostic imaging devices, illumination systems, alignment tools and portions of surgical/therapeutic systems that direct light at the eye); test laboratories performing optical radiation safety verification; regulatory bodies and notified bodies assessing conformity; clinical engineers and risk-assessment teams preparing instructions for safe use. Users apply the standard to classify devices, test emissions, set labeling and warnings, and demonstrate compliance with internationally accepted light-hazard exposure limits.

Related standards

Part of the ISO 15004 series and the ISO/TC 172/SC 7 family of ophthalmic optics and instruments standards. Closely related documents include ISO 15004-1 (General requirements applicable to all ophthalmic instruments, edition 2, 2020) and other product-specific standards such as ISO 15752 (endoilluminators) and various ISO/CEN vertical standards that specify instrument-specific light-hazard requirements; project work on TR/15004-3 provides background guidance for light-hazard specification. Users should consult the applicable vertical standard for device-specific requirements.

Keywords

ophthalmic instruments, light hazard, optical radiation, irradiance, radiance, retinal exposure, photochemical limit, thermal limit, pulse duration, Group 1, Group 2, test methods, manufacturer information, exposure limits.

FAQ

Q: What is this standard?

A: ISO 15004-2:2024 is the second-edition international standard that defines fundamental optical radiation safety requirements and test methods for ophthalmic instruments with respect to light-hazard protection.

Q: What does it cover?

A: It covers classification, terminology, exposure limits (250–2 500 nm), measurement and test procedures for continuous and pulsed emissions, manufacturer information and warnings, and guidance on applying limits when therapeutic beams affect non-target tissue. Vertical product standards take precedence when they contain different light-hazard requirements.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, conformity assessment bodies, regulators, clinical engineers and risk-assessment teams involved with ophthalmic instruments.

Q: Is it current or superseded?

A: Current — published as Edition 2 on 5 December 2024. It cancels and replaces ISO 15004-2:2007 (the 2007 edition was withdrawn).

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 15004 series (fundamental requirements and test methods). Part 1 covers general requirements (ISO 15004-1:2020); other related and product-specific standards are maintained by ISO/TC 172/SC 7.

Q: What are the key keywords?

A: Optical radiation safety, ophthalmic instruments, light hazard protection, exposure limits, irradiance, radiance, photochemical and thermal limits, pulsed emission testing, device classification.