Overview
ISO/TR 22463:2019 provides guidance on the selection and use of patient eye protectors (PEPs) for medical and cosmetic procedures that use lasers or intense light sources (ILS). It helps employers, safety advisors and clinical users perform risk assessments and choose appropriate eye protection to reduce ocular hazards (retinal damage, photophobia, pupillary distortion) during procedures in the face, neck and body. The report focuses on patient/client protection only - it does not cover eye protection for equipment operators, nor PEPs for tanning or ophthalmic instruments.
Key Topics
- Scope and exclusions: PEPs for patients/clients during laser/ILS procedures; excludes operator protection and tanning/ophthalmic use.
- Definitions: Key terms such as PEP, ILS, IPL, Class 1C, MPE (maximum permissible exposure), optical density (OD), stray optical radiation and Bell’s phenomenon.
- Risk assessment: Guidance for the responsible person or LSO/ILSSO to assess whether device output can exceed MPE/EL and to consider wavelength, delivery system, positioning, body location and treatment intent.
- Selection criteria:
- Ensure good fit to prevent light leakage around the periorbital area.
- Choose opaque or appropriately attenuating PEPs (sufficient OD across relevant wavelengths).
- Select PEPs with resistance to intense radiation expected during treatment.
- Account for topical compounds and metallic items (piercings) that may affect reflections.
- Usage conditions: Different recommendations depending on treatment location - below face/neck, face/neck (non-periorbital), periorbital region, and eyelid procedures.
- Labelling and administrative procedures: Requirements for labelling (where applicable) and local protocols to ensure safe use.
- Informative annexes: Annex A (reported injuries/incidents) and Annex B (commercially available PEP types).
Applications and Users
Who uses ISO/TR 22463:2019:
- Medical and cosmetic clinic owners/operators
- Laser/ILS users and assistants
- Laser/ILS safety officers and safety advisors
- Occupational health professionals and regulators
Practical uses:
- Developing local safety protocols and patient-protection procedures
- Selecting appropriate PEP types (opaque inserts, adhesive shields, molded eye cups)
- Training staff on fit checks, light-leak inspection and pre-treatment risk controls
Related Standards
- IEC/TR 60825-8 (lasers) - guidance on laser safety
- IEC/TR 62471-3 (ILS) - photobiological safety guidance
- IEC 60825-14, ISO 12609-1 / ISO 12609-2 - additional guidance for operator and device safety
Keywords: ISO/TR 22463:2019, patient eye protectors, PEP, laser safety, ILS protection, optical density, MPE, periorbital protection, risk assessment.
Open preview (PDF)Patient and client eye protectors for use during laser or intense light source (ILS) procedures — Guidance
