IEC TR 60825-8:2022

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
IEC TR 60825-8:2022-09(en)

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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




  Warning! Make sure that you obtained this publication from an authorized distributor.


® Registered trademark of the International Electrotechnical Commission

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– 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

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IEC TR 60825-8:2022 © IEC 2022 – 3 –
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

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– 4 – IEC TR 60825-8:2022 © IEC 2022
E.2.1 General . 35
E.2.2 Cables . 35
E.2.3 Emergency switches . 36
E.2.4 Interlocks . 36
E.2.5 Indicators . 36
E.2.6 Beam RADIANT POWER or pulse energy . 36
E.2.7 Articulated arm . 36
E.2.8 Beam coincidence . 36
E.2.9 Optical fibres . 36
E.2.10 Aiming beam. 37
E.2.11 Calibration of the RADIANT POWER (see also E.2.6) . 37
E.2.12 Specialized accessories . 37
E.2.13 Protective eyewear . 37
E.3 Preventive maintenance . 37
E.3.1 General . 37
E.3.2 Cleaning and disinfection . 38
E.3.3 Preventive maintenance checklist . 38
E.3.4 Checks prior to use . 38
Annex F (informative) Safety issues in laser applications . 40
F.1 General . 40
F.2 Use of optical fibres . 40
F.2.1 General . 40
F.2.2 Hazard summary . 40
F.2.3 Precautions . 40
F.3 Use of flexible endoscopes . 41
F.3.1 General . 41
F.3.2 Hazard summary . 41
F.3.3 Precautions . 41
F.4 Use of lasers with rigid endoscopes, microscopes and colposcopes . 42
F.4.1 General . 42
F.4.2 Hazard summary . 42
F.4.3 Precautions . 42
F.5 Use of lasers with free hand manipulation capability . 42
F.5.1 General . 42
F.5.2 Hazard summary . 42
F.5.3 Precautions . 43
F.6 Use of lasers in eye surgery . 43
F.6.1 Hazard summary . 43
F.6.2 Precautions . 43
F.7 Use of lasers in conjunction with anaesthesia . 43
F.7.1 Hazard summary . 43
F.7.2 Precautions . 43
Bibliography . 45

Table A.1 – Summary of pathological effects associated with excessive exposure
to light . 22
Table D.1 – List of training items and allocation to persons involved (arbitrary order) . 34
Table E.1 – Inspection schedule . 35

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IEC TR 60825-8:2022 © IEC 2022 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

SAFETY OF LASER PRODUCTS –

Part 8: Guidelines for the safe use of lasers on humans

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
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2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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6) All users should ensure that they have the latest edition of this publication.
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC TR 60825-8 has been prepared by IEC technical committee 76: Optical radiation safety and
laser equipment. It is a Technical Report.
This third edition cancels and replaces the second edition published in 2006. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition.
a) Recent medical laser equipment classified as laser class 1C is now included. Equipment of
laser class 1C incorporates sensors which ensure good contact, so that laser emission into
free space is inhibited.
b) More emphasis is given to protective eyewear of patients or clients, to the burning of
materials close to the skin and to collateral hazards such as from internal or external fire
and from noxious gases.
c) General technical update.

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– 6 – IEC TR 60825-8:2022 © IEC 2022
The text of this Technical Report is based on the following documents:
Draft Report on voting
76/640/DTR 76/658/RVDTR

Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Technical Report is English.
Terms written in small capitals in this document are defined in Clause 3.
A list of all parts in the IEC 60825 series, published under the general title Safety of laser
products, can be found on the IEC website.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/publications.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under webstore.iec.ch in the data related to the
specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

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IEC TR 60825-8:2022 © IEC 2022 – 7 –
INTRODUCTION
Lasers emit visible or invisible optical radiation or both. In some cases, this radiation is a parallel
beam with almost no divergence. This means that the inherently high IRRADIANCE of the laser is
maintained over considerable distances. Due to the laser irradiation properties, injuries to the
eye and skin can occur. Annex A includes descriptions of laser systems and some medical
applications.
Lasers present hazards to anyone present during the operation of the laser. Serious risks of
injury, particularly to the eye, or undesired effects can result from lack of protective measures,
the use of faulty laser equipment, misdirected beams or inappropriate laser controls or settings.
Lasers which are used in contact mode on the skin may be classified as laser class 1C. These
laser systems incorporate safety means which ensure that laser radiation can only be emitted
if the interlocks detect good contact with the skin so that free space emission above the AEL of
class 1 is prohibited. When used correctly, class 1C laser systems are considered safe for the
eyes.
This document is intended to give direction as to how aspects of laser safety are incorporated
into medical laser practice. It is not intended to take precedence over existing or proposed
national guidance. However, where none exists, this document is intended to provide helpful
information.
Although the LASER USER has direct responsibility for safety during laser use, the employer,
referred to in this document as RESPONSIBLE PERSON, bears the responsibility for the setting up
of a framework for the safe use of the system. A LASER SAFETY OFFICER (LSO) can be appointed
to provide expert advice to the RESPONSIBLE PERSON and all personnel concerned with the laser
operation. This document emphasizes the need for appropriate laser safety training for all staff
involved in providing practical guidance on installation, operation, maintenance and servicing.

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– 8 – IEC TR 60825-8:2022 © IEC 2022
SAFETY OF LASER PRODUCTS –

Part 8: Guidelines for the safe use of lasers on humans



1 Scope
This part of IEC 60825, 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.
NOTE Premises where lasers are used include, but are not limited to, health-care facilities, dental-care practices,
physiotherapy, beauty-care and cosmetic facilities.
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.
The subject areas covered in this document include
– BEAM DELIVERY SYSTEMS;
– biological effects of laser radiation;
– reporting of ACCIDENTS and dangerous situations, and
– checklists.
The object of this document is to enhance the protection of persons from laser radiation and
other associated hazards by providing guidance on how to establish safety procedures,
precautions and user control measures.
Medically relevant advice such as about treatment indications, counter-indications, patient or
client condition, medical or beauty-care treatment procedures, patch testing, medication,
adverse tissue or skin conditions and follow-up controls is beyond the scope of this document.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
accident
unforeseen situation which results in an injury to any individual
3.2
beam delivery system
mechanism or device which delivers the laser output to the target site
EXAMPLE fibre optics, handpiece, m
...