EN ISO 12609-1:2025 PDF

Overview

EN ISO 12609-1:2025 - Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications (Part 1: Specification for products) specifies product requirements for eye and face protectors used with intense light source (ILS) equipment. The standard covers protection against excessive optical radiation in the spectral range 250 nm to 3 000 nm (non‑laser), and applies to both operator protectors and devices intended for patient protection during ILS procedures (except for treatments in the periorbital area). It excludes laser protectors, medically prescribed tints, solar sunglasses for non‑occupational use, tanning equipment protectors, and protection against ionizing radiation.

Key topics and technical requirements

This standard defines general and test requirements for ILS eye protectors, including:

• Classes of ILS eye protectors and intended use categories.
• Transmittance requirements (luminous and spectral) and matching across filter scales (F‑ and B‑scale designations).
• Colour neutrality as an optional requirement to avoid clinically significant colour distortion.
• Autodarkening filters: optical transmittance, angular dependence and switching-time requirements for filters that change state during procedures.
• Construction and ergonomics: materials, physiological compatibility, adjustment systems, cleaning/disinfection, headform fit and field of view requirements.
• Optical properties: spherical/cylindrical power, spatial deviation, prismatic effects and narrow‑angle scatter.
• Mechanical and thermal performance: resistance to ignition, UV and thermal exposure, basic impact level and failure criteria.
• Marking and manufacturer information: mandatory markings, user instructions and information to be supplied with the product.

The standard references test methods (ISO 18526 series) and aligns with personal protective equipment regulations for conformity assessment.

Applications

EN ISO 12609-1 is directly applicable to:

• Eye and face protectors used by clinicians and technicians operating ILS equipment in dermatology, aesthetics, veterinary medicine, dentistry and other clinical/cosmetic procedures.
• Patient protective devices used during non‑periorbital ILS treatments.
• Manufacturers designing filters, goggles, and face shields for non‑laser intense light procedures.

Who should use this standard

• Product designers and manufacturers of ILS eye protectors seeking compliance and market access in Europe.
• Clinical safety officers, procurement teams and biomedical engineers evaluating protective eyewear for medical and cosmetic facilities.
• Test laboratories performing optical and mechanical testing against ISO test methods.
• Regulatory and quality professionals using standards to demonstrate conformity with EU Regulation 2016/425.

Related standards

• ISO 12609-2 (selection and use guidance)
• ISO/TR 22463 (patient eye protection guidance)
• ISO 19818-1 (laser eye protection)
• ISO 18526 series (test methods for optical and mechanical properties)
• ISO 12312 (solar/eyewear standards) and IEC 61331-3 (ionizing radiation protection)

Keywords: EN ISO 12609-1:2025, ILS eye protectors, intense light sources, optical radiation, medical and cosmetic eye protection, autodarkening filters, transmittance, EU Regulation 2016/425.