Overview
IEC TR 60825-8:2022 - "Safety of laser products – Part 8: Guidelines for the safe use of lasers on humans" - is a Technical Report from the IEC that provides practical guidance for the safe interventional use of lasers classified as laser class 1C, 3B or 4 on humans. It is intended for employers, the responsible person, laser safety officers (LSOs), laser users, maintenance staff and others involved in clinical and non‑consumer interventional applications. The report explains recommended control measures, basic engineering protections and procedural safeguards to protect patients, staff and bystanders.
Key topics and requirements
- Hazards and preventive measures
- Eye hazards and selection/usage of laser protective eyewear for personnel and patients
- Skin protection and strategies to prevent thermal injury
- Fire risk, combustion of endogenous gases and airway fire mitigation
- Management of hazardous plumes and smoke evacuation systems
- Administrative controls
- Roles and duties of the Laser Safety Officer (LSO)
- Incident and accident reporting, medical examination and follow‑up
- Maintenance, inspection schedules and quality assurance tests
- Training and competency
- Recommended content and frequency for laser safety training for operators and support staff
- Laser environment and engineering controls
- Definition and management of the laser controlled area
- Access controls, warning signs, illuminated indicators, door interlocks
- Brief descriptions of built‑in engineering controls and laser delivery systems
- Supporting guidance
- Informative annexes: biological effects, window shielding, installation checklists, inspection schedules and application‑specific safety issues
Practical applications and who uses this standard
IEC TR 60825-8:2022 is primarily used in interventional settings where lasers are applied to humans - for example in surgical suites, ophthalmology, dermatology, cosmetic/aesthetic clinics and other clinical treatment areas. Key users include:
- Employers and facility managers developing laser safety programs
- Laser Safety Officers (LSOs) creating policies, risk assessments and incident procedures
- Clinicians and laser operators implementing safe work practices
- Biomedical engineers and maintenance personnel performing inspections and QA
- Regulators and safety auditors evaluating compliance with recommended controls
Related standards
- Part of the IEC 60825 series (laser product safety family). Organizations implementing IEC TR 60825-8:2022 should also consult other parts of the IEC 60825 series and applicable national medical device and occupational safety regulations for complete compliance.
Keywords: IEC TR 60825-8:2022, Safety of laser products, laser safety, laser use on humans, laser protective eyewear, Laser Safety Officer, interventional laser applications, class 1C 3B 4.