IEC TR 60825-8:2022

Safety of laser products - Part 8: Guidelines for the safe use of lasers on humans

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.

General Information

• Status: Published
• Publication Date: 13-Sep-2022
• ICS: 11.040.99 - Other medical equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• 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: 13-Sep-2022
• Completion Date: 14-Sep-2022

Relations

• Revises: IEC TR 60825-8:2006 - Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC TR 60825-8 ®
Edition 3.0 2022-09
TECHNICAL
REPORT
Safety of laser products –
Part 8: Guidelines for the safe use of lasers on humans
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IEC TR 60825-8 ®
Edition 3.0 2022-08
TECHNICAL
REPORT
Safety of laser products –
Part 8: Guidelines for the safe use of lasers on humans

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.99; 31.260 ISBN 978-2-8322-5285-7

– 2 – IEC TR 60825-8:2022 © IEC 2022
CONTENTS
FOREWORD . 5
INTRODUCTION . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Hazards and preventive measures . 10
4.1 Risks to eyes . 10
4.1.1 General . 10
4.1.2 Laser protective eyewear of personnel . 10
4.1.3 Laser protective eyewear of patients or clients . 11
4.1.4 Eye protection with viewing optics . 11
4.1.5 Eye protection of persons behind room windows . 11
4.1.6 Reflecting surfaces . 12
4.2 Risks to skin . 12
4.2.1 General . 12
4.2.2 Skin protection against laser radiation . 13
4.2.3 Protection against burning of materials close to the skin . 13
4.3 Risk of internal combustion . 13
4.3.1 General . 13
4.3.2 Protection against combustion of endogenous gases . 13
4.3.3 Protection against airway fire . 14
4.3.4 Protection against burning of an endoscope . 14
4.4 Risks due to inhalation of noxious fumes and plumes. 14
4.4.1 General . 14
4.4.2 Dedicated smoke evacuation systems . 15
4.4.3 Central vacuum suction systems . 15
4.4.4 Face masks . 15
4.4.5 Disposal of filters . 15
5 Administrative procedures . 16
5.1 LASER SAFETY OFFICER (LSO) . 16
5.1.1 General . 16
5.1.2 Duties and responsibilities of the LSO . 16
5.2 INCIDENTS and ACCIDENTS . 17
5.2.1 General . 17
5.2.2 Initial reporting . 17
5.2.3 Medical examination . 17
5.2.4 Medical surveillance . 17
5.2.5 Investigation of the circumstances of the event . 17
5.2.6 INCIDENT and ACCIDENT follow-up . 18
5.3 Maintenance and inspection . 18
5.3.1 Maintenance . 18
5.3.2 Inspection schedule . 19
6 Laser safety training recommendations . 19
7 Laser environment . 19
7.1 The LASER CONTROLLED AREA . 19

7.2 Access controls. 19
7.2.1 General . 19
7.2.2 Warning signs . 19
7.2.3 Illuminated warning indicators . 20
7.2.4 Door switches and interlocks . 20
7.3 Fire protection policy. 20
Annex A (informative)  Biological effects, hazards, laser equipment technology . 21
A.1 Biological effects and hazards . 21
A.1.1 General . 21
A.1.2 Hazards to the eye . 22
A.1.3 Hazards to the skin . 23
A.1.4 Determination of NOHD . 24
A.2 Laser applications . 24
A.2.1 General . 24
A.2.2 Area of application . 24
A.2.3 Types of application . 24
A.3 Laser equipment technology . 25
A.3.1 Laser radiation sources . 25
A.3.2 Laser radiation delivery systems . 25
Annex B (informative)  Window shielding . 29
B.1 General . 29
B.2 Laser wavelength . 29
B.3 Resistance to fire and heat . 29
B.4 Removable attachments . 29
Annex C (informative) Checklist for laser installation. 31
C.1 General . 31
C.2 Identify . 31
C.3 Determine relevant information . 31
C.3.1 Details of laser . 31
C.3.2 Other hazards . 31
C.3.3 Application . 31
C.3.4 Life cycle . 31
C.4 Risk assessment . 32
C.4.1 General . 32
C.4.2 Laser beam . 32
C.4.3 Non-laser hazards . 32
C.5 Treatment unit . 32
C.6 Authorization and training of personnel . 33
C.7 Operating procedures . 33
C.7.1 Pre-use testing . 33
C.7.2 INCIDENT procedure . 33
C.8 Annual audit . 33
C.8.1 Installation . 33
C.8.2 Risk assessment . 33
Annex D (informative)  Laser safety training. 34
Annex E (informative)  Inspection schedule . 35
E.1 General . 35
E.2 Quality assurance (QA) tests . 35

– 4 – IEC TR 60825-8:2022 © IEC 2022
E.2.1 General . 35
E.2.2 Cables . 35
E.2.3 Emergency switches .
...