IEC TR 60825-8:2022
(Main)Safety of laser products - Part 8: Guidelines for the safe use of lasers on humans
General Information
- Abstract
IEC 60825:2022, which is a Technical Report, serves as a guide to the employer, the responsible person, the laser safety officer, the laser user and other persons involved, on the safe use of lasers and laser equipment classified as laser class 1C, 3B or 4 in interventional applications of laser beams on humans, excluding use of consumer products. This document explains the control measures recommended for the safety of the laser user, patients, clients, staff, maintenance personnel and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection.
- Status
- Published
- Publication Date
- 13-Sep-2022
- Technical Committee
- TC 76 - Optical radiation safety and laser equipment
- Drafting Committee
- WG 4 - TC 76/WG 4
- Current Stage
- PPUB - Publication issued
- Start Date
- 14-Sep-2022
- Completion Date
- 13-Sep-2022
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.
Relations
- Effective Date
- 05-Sep-2023
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Frequently Asked Questions
IEC TR 60825-8:2022 is a technical report published by the International Electrotechnical Commission (IEC). Its full title is "Safety of laser products - Part 8: Guidelines for the safe use of lasers on humans". This standard covers: IEC 60825:2022, which is a Technical Report, serves as a guide to the employer, the responsible person, the laser safety officer, the laser user and other persons involved, on the safe use of lasers and laser equipment classified as laser class 1C, 3B or 4 in interventional applications of laser beams on humans, excluding use of consumer products. This document explains the control measures recommended for the safety of the laser user, patients, clients, staff, maintenance personnel and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection.
IEC 60825:2022, which is a Technical Report, serves as a guide to the employer, the responsible person, the laser safety officer, the laser user and other persons involved, on the safe use of lasers and laser equipment classified as laser class 1C, 3B or 4 in interventional applications of laser beams on humans, excluding use of consumer products. This document explains the control measures recommended for the safety of the laser user, patients, clients, staff, maintenance personnel and others. Engineering controls which form part of the laser equipment or the installation are also briefly described to provide an understanding of the general principles of protection.
IEC TR 60825-8:2022 is classified under the following ICS (International Classification for Standards) categories: 11.040.99 - Other medical equipment; 31.260 - Optoelectronics. Laser equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
IEC TR 60825-8:2022 has the following relationships with other standards: It is inter standard links to IEC TR 60825-8:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
IEC TR 60825-8:2022 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.