IEC TR 60825-8:2006

TECHNICAL IEC
REPORT TR 60825-8
Second edition
2006-12
Safety of laser products –
Part 8:
Guidelines for the safe use of laser
beams on humans
Reference number
IEC/TR 60825-8:2006(E)
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TECHNICAL IEC
REPORT TR 60825-8
Second edition
2006-12
Safety of laser products –
Part 8:
Guidelines for the safe use of laser
beams on humans
© IEC 2006 ⎯ Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or
mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
PRICE CODE
Commission Electrotechnique Internationale W

International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
For price, see current catalogue

– 2 – TR 60825-8 © IEC:2006(E)
CONTENTS
FOREWORD.3
INTRODUCTION.5

1 Scope and object .6
2 Normative references.6
3 Terms and definitions .6
4 Hazards, goals and control measures.9
4.1 Risks to eyes.9
4.2 Risks to skin.10
4.3 Fire and burn hazards.11
4.4 Fumes, plumes and vapours .12
4.5 Collateral hazards.13
5 Administrative procedures.13
5.1 LASER SAFETY OFFICER (LSO) .13
5.2 Medical supervision (ophthalmic surveillance) .15
5.3 INCIDENT and ACCIDENT reporting.15
5.4 Maintenance and inspection.16
6 Training recommendations.16
7 Laser environment .17
7.1 The LASER CONTROLLED AREA.17
7.2 Windows .18
7.3 Walls.18
7.4 Fire protection .18

Annex A (informative) Biological effects, hazards, laser equipment technology.19
Annex B (informative) Window shielding.26
Annex C (informative) Checklist for laser installation .27
Annex D (informative) Laser safety training .30
Annex E (informative) Inspection schedule .31
Annex F (informative) Safety issues in laser applications .36

Bibliography .40

Table A.1 – Summary of pathological effects associated with excessive exposure to light .20
Table E.1 – Inspection schedule.33

TR 60825-8 © IEC:2006(E) – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY OF LASER PRODUCTS –
Part 8: Guidelines for the safe use
of laser beams 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 in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
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.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 60825-8, which is a technical report, has been prepared by IEC technical committee 76:
Optical radiation safety and laser equipment.
This second edition cancels and replaces the first edition published in 1999. It constitutes a
technical revision. This second edition, which is the result of continued maintenance work on
the previous edition, reflects more thorough consideration of the hazards involved. It also takes
into account newer laser technology and laser radiation supply instrumentation, and addresses
refined application procedures. Additionally, this second edition implements more recent
information available from other standards relevant to safety procedures, which have been
revised in recent years. Further technical developments in this area will be reflected on an
ongoing basis in future amendments or editions of this technical report.

– 4 – TR 60825-8 © IEC:2006(E)
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
76/316/DTR 76/329/RVC
Full information on the voting for the approval of this technical report can be found in the report
on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
Terms indicated in small capitals are defined in Clause 3.
A list of all parts of the IEC 60825-8 series, published under the general title Safety of laser
products, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
A bilingual version of this technical report may be issued at a later date.

TR 60825-8 © IEC:2006(E) – 5 –
INTRODUCTION
Lasers emit visible and/or invisible optical radiation. In some cases, this radiation is a parallel
beam with almost no divergence. This means that the inherently high IRRADIANCE of the laser
may be maintained over considerable distances. Because of this, the beam may be focused to
a very small area, which may be hazardous to the eye or skin. Annex A includes descriptions of
laser systems and some medical applications.
Lasers may present hazards to anyone present during the operation of the laser. Serious risks
of injury, in particular to the eye, and/or undesired effects can result from lack of protective
measures, the use of faulty laser equipment, misdirected beams or inappropriate laser control
settings.
This guide is intended to give direction as to how aspects of laser safety may be incorporated
into medical laser practice. Its publication as a technical report indicates that it is not intended
to take precedence over existing or proposed national guidance. However, where none exists,
this guide should prove helpful.
Although the LASER OPERATOR has direct responsibility for safety during laser use, the employer
bears the responsibility for the setting up of a framework for the safe use of the system. This
guide strongly advocates the appointment of a LASER SAFETY OFFICER to provide expert advice
to the employer and all personnel concerned with the laser operation. This guide emphasizes
the need for appropriate laser safety training for all staff involved in providing practical
guidance on installation, operation, maintenance and servicing.

– 6 – TR 60825-8 © IEC:2006(E)
SAFETY OF LASER PRODUCTS –
Part 8: Guidelines for the safe use
of laser beams on humans
1 Scope and object
This part of IEC 60825 serves as a guide to the employer, the RESPONSIBLE ORGANISATION, the
LASER SAFETY OFFICER, the LASER OPERATOR and other persons involved, on the safe use of
lasers and laser equipment classified as class 3B or class 4. It covers all applications of laser
beams on humans in, but not limited to, health-care facilities, cosmetic and hair removal
centres and dental practices, including applications in vehicles and domestic premises.
NOTE Although the scope excludes laser classes lower than class 3B and 4, it is appropriate to state, that
particular care should be taken when levels of laser energy are used below the Class 3B and 4 limits when the
individual’s normal AVERSION RESPONSES are compromised or absent.
This technical report explains the control measures recommended for the safety of patients,
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 guide include
– BEAM DELIVERY SYSTEMS;
– biological effects of laser radiation;
– reporting of ACCIDENTS and dangerous situations;
– checklists.
The object of this report 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For
dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments) applies.
None.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE Reference is also made, as indicated, to individual terms and definitions in IEC 60825-1 and IEC 60601-2-22.
3.1
accident
unforeseen situation which results in an injury to the patient and/or other personnel

TR 60825-8 © IEC:2006(E) – 7 –
3.2
aversion response
movement of the eyelid or the head to avoid an exposure to a noxious stimulant or bright light
NOTE For visible lasers the AVERSION RESPONSE is assumed to occur within 0,25 s.
3.3
beam delivery system
optical system which delivers the laser beam to the target area, focuses or shapes the laser beam
and makes it manoeuvrable
NOTE 1 Examples of a beam delivery system include fibre optic, handpiece, micromanipulator or scanning device.
NOTE 2 See also 2.1.106 of IEC 60601-2-22.
3.4
incident
potentially dangerous situation which could result in an injury to the patient and/or other
personnel
3.5
irradiance
RADIANT POWER divided by the irradiated area
-2
NOTE See also 3.39 of IEC 60825-1. IRRADIANCE is expressed in Wm .
3.6
laser controlled area
area where laser safety controls apply
NOTE See also 3.41 of IEC 60825-1.
3.7
laser operator
person who handles the laser equipment and in general controls the application of the laser
radiation at the working area
NOTE The LASER OPERATOR may appoint other person(s), who assist with the selection and/or setting of the
parameters.
3.8
laser safety officer
LSO
one who is knowledgeable in the evaluation and control of laser hazards and has responsibility
for oversight of the control of laser hazards
[IEC 60825-1, definition 3.47]
3.9
maximum permissible exposure
MPE
that level of radiation to which, in normal circumstances, the skin or eye may be exposed
without suffering adverse effects
NOTE See also 3.55 and A.2 of IEC 60825-1.
3.10
nominal ocular hazard area
NOHA
area within which the IRRADIANCE or RADIANT EXPOSURE can exceed the MPE
NOTE See also 3.59 of IEC 60825-1.

– 8 – TR 60825-8 © IEC:2006(E)
3.11
nominal ocular hazard distance
NOHD
distance from the laser aperture within which the IRRADIANCE or RADIANT EXPOSURE can exceed
the MPE
NOTE See also 3.60 of IEC 60825-1.
3.12
operator
See LASER OPERATOR.
3.13
optical density
OD
value that defines the attenuation property of a filter
NOTE For example, when the attenuation value is 1/100, the OD is 2; when the value is 100 000, the OD is 5. See
3.86 of IEC 60825-1.
3.14
pulse duration
time increment measured between the half peak power points at the leading and trailing edges
of a pulse
[IEC 60825-1, definition 3.65]
3.15
radiant exposure
radiant energy divided by the irradiated area
–2
NOTE See also 3.69 of IEC 60825-1. RADIANT EXPOSURE is expressed in Jm .
3.16
radiant power
power emitted, transferred or received in the form of radiation
[IEC 60825-1, definition 3.70]
NOTE RADIANT POWER is expressed in watts.
3.17
remote interlock connector
socket or terminal on the laser equipment, allowing for connection of a remote interlock to
make provisions to interrupt the laser’s emission with a door interlock or other external safety
switches
NOTE See also 3.72 of IEC 60825-1.
3.18
responsible organisation
individual or group responsible for the use and maintenance of equipment, and for assuring
that LASER OPERATORS are adequately trained
3.19
ultra low penetration air filter
ULPA
porous filter normally used for removing particulate matter from the laser plume

TR 60825-8 © IEC:2006(E) – 9 –
4 Hazards, goals and control measures
4.1 Risks to eyes
The eye is at risk of injury from laser radiation in excess of the MAXIMUM PERMISSIBLE EXPOSURE
(MPE). In particular, laser radiation at wavelengths between 400 nm and 1 400 nm may be
focussed onto the retina resulting in permanent damage to vision. Refer to Annex A.
4.1.1 Goal
Any person who is present within the NOMINAL OCULAR HAZARD AREA (NOHA) should be
protected against unintended laser exposure above the MAXIMUM PERMISSIBLE EXPOSURE (MPE)
for the cornea.
4.1.2 Control measures
4.1.2.1 Laser protective eyewear (goggles or glasses)
Unless there is no reasonably foreseeable risk (as assessed by the LSO, see Clause C.4) that
personnel may be exposed to laser radiation in excess of the MPE, eye protection specifically
designed for the wavelength(s) and output in use should be worn in addition to any other
controls that may be in place. “Personnel” includes the patient, the LASER OPERATOR, the
anaesthetist, assisting staff and others. It is one of the duties of the LSO to specify appropriate
eyewear, resistant to the power or energy levels of the working beam expected during
reasonably foreseeable hazard conditions. When the target area is close to the eye, the
patient’s eye protection should be selected carefully, since the aiming beam as well as the
working beam IRRADIANCE or RADIANT EXPOSURE may exceed the MPE. Additionally, the
AVERSION RESPONSE may be altered due to anaesthesia or sedation.
Laser protective eyewear should be clearly marked with the wavelength(s) and corresponding
OPTICAL DENSITY. Additionally, it is recommended that an unambiguous and robust method of
marking the laser safety eyewear be employed to ensure that there is a clear link to the
particular laser for which it has been specified.
The extent of the NOHA will vary according to the type of laser used and the optical properties
of the applicators used. Placement of the laser equipment and the patient within the room can
do much to control the direction and reduce the risk of exposure to errant beams.
As an alternative to having many people in the NOHA, which would require many pairs of
goggles to be available, consideration should be given to installing a remote video monitor
outside the NOHA.
NOTE There is concern that eyewear with correct OPTICAL DENSITY may shatter, if subjected to laser radiation with
very high IRRADIANCE or RADIANT EXPOSURE. The European Standard EN 207:2002 contains the requirement, that the
eyewear has to withstand such high IRRADIANCE or RADIANT EXPOSURE as long as 10 s. In many EU member
countries, laser eyewear has to comply with this standard, In other countries, laser eyewear may not necessarily
comply.
4.1.2.2 Eye protection with viewing optics
When using viewing optics, e.g. endoscopes, microscopes, colposcopes, slit lamps and other
optical devices, the person(s) looking through the eyepiece(s) should be protected with a
suitable filter or a shutter fitted to reduce the risk from radiation reflected through the vision
channel. In case of monocular optics, consideration should be given to protecting the
unshielded eye.
The use of a video endoscope can overcome the problems of reflected radiation in the viewing
optics. However, it is still advisable for all persons present to wear eye protection when there is
a risk of fibre breakage, or possible firing of the laser when the fibre is out of the endoscope. A
risk assessment should be undertaken by the LSO.

– 10 – TR 60825-8 © IEC:2006(E)
4.1.2.3 Windows
Persons behind windows can be adequately protected by means of an opaque material
temporarily attached or unfolded at the window inside the room. For carbon dioxide lasers or
other lasers which emit at wavelengths longer than approximately 4 000 nm, glass or plastics
may provide sufficient absorption. Windows and shields should provide sufficient protection
against IRRADIANCE for the exposure duration likely to be encountered in normal use, as
identified in the risk assessment carried out by the LSO. For possible technical solutions, see
Annex B.
4.1.2.4 Reflecting surfaces
Reflections from shiny surfaces such as surgical instruments may focus the laser beam, which
can be hazardous, particularly to the eyes. Depending on the wavelength and beam

configuration, diffuse reflections from the irradiated tissue from class 4 lasers may also be
hazardous. In order to reduce hazards due to reflected laser radiation the following should be
considered:
NOTE Class 3B laser diffuse reflections are not normally considered hazardous.
a) Wall and ceiling surface or texture
The surface of the wall and ceiling should be chosen such that reflections are minimized.
The LSO should consider the risks due to possible reflections. A matt finish of any colour
will minimize the reflections.
b) Room equipment
Glossy surfaces may be found with windows, cupboards, vent frames, sterilization cases,
X-ray viewing screens, video monitors, operating room lights, etc. Shiny surfaces may
reflect laser radiation in an unpredictable way. The LSO should identify the hazards
involved and decide on the appropriate measures to be taken. The checklist as described in
Annex C may be used.
c) Instrumentation
Care should be taken to prevent the unintentional reflection of the laser beam from an
instrument. If the laser beam is likely to hit an instrument, any such instruments which may
be used with a laser should either be
– convex with small radii, if polished, or
– roughened.
The OPERATOR should be aware that a surface which does not reflect visible light may reflect
long-wavelength infra-red laser radiation such as that from a CO laser. Black instruments may
absorb sufficient energy to become hot, causing unintended patient burns. These instruments
may also be significantly reflective at infra-red wavelengths. When working in the upper
respiratory/digestive tract, the OPERATOR should consider that a reflected beam or a hot
instrument can perforate the endotracheal tube, possibly igniting it, with the risk of a severe
endotracheal fire, see also Annex F.
Reflective surfaces are sometimes used to deflect the laser energy into an otherwise
inaccessible operating site. Mirrors or other reflective devices should be suitable for the laser
wavelengths and powers or energies employed.
NOTE Glass mirrors may shatter if used at high laser powers.
4.2 Risks to skin
Although an acute skin injury resulting from exposure to laser radiation is less likely to affect
the individual’s quality of life, it should be recognised that the skin presents a much larger
target than the eye and therefore the probability of exposure may be higher. Of particular
concern is exposure of the skin to laser radiation below 400 nm, which may increase the risk of
skin cancer. Refer to Annex A.

TR 60825-8 © IEC:2006(E) – 11 –
4.2.1 Goal
All personnel including the patient/client should be sufficiently protected against unintended
hazardous laser exposure.
4.2.2 Control measures
The LSO should recommend or approve the use of appropriate clothing or drapes of low
flammability, as determined from the risk assessment, see Annex C. When working with lasers
in the UV region, a protective skin cream should be considered to be used, in order to avoid an
erythema.
4.3 Fire and burn hazards
Lasers of class 4 may produce sufficient energy to ignite flammable materials particularly in
oxygen enriched atmospheres.
4.3.1 Goal
All personnel including the patient/client should be sufficiently protected against burns.
4.3.2 Methods of compliance
4.3.2.1 Endotracheal fires
When performing airway laser surgery in the presence of endotracheal tubes, the tube should
have adequate protection or be specially designed to reduce the likelihood of fire. For more
detailed information on this subject, reference is made to ISO/TR 11991. Fire hazards related
to endotracheal tubes, plastics, adhesive tapes, ointment and surgical preparatory solutions
can be controlled by various methods. These include (but are not confined to) the use of
non-combustible surgical instrumentation, Venturi (jet) ventilation techniques, shielding with
wet substances and the use of low-combustion gas mixtures. Anaesthetics personnel should
use non-flammable, specially manufactured or adequately protected laser resistant tubes.
Standard plastic and rubber tubes are particularly hazardous and should be avoided, unless
there is no practical alternative. There have been ACCIDENTS involving spirally wound metal
tapes and these should be avoided. If there is no medical contra-indication, the endotracheal
tube cuffs should be inflated with liquid and externally protected with wet swabs.
Since combustion may be initiated in the respiratory/digestive tract in high oxygen
concentrations, or in the presence of oxidizing gases (nitrous oxide), the lowest possible
concentration of oxygen should be used in laryngo-tracheal procedures. In some cases where
co-axial fibres are used, CO can be passed down the fibre at a low rate to minimize
flammability at the laser target site. Care should be taken to monitor p(O ).
NOTE The anaesthesiologist should be consulted. A typical rate is 250 cm per minute.
4.3.2.2 Endogeneous combustion
In order to avoid combustion of endogeneous gases like methane in the gastro-intestinal tract,
localized ventilation techniques should be employed.
4.3.2.3 Endoscope burns
Care should be taken to avoid laser beam exposure of the sheaths of flexible fibre optic
endoscopes since most of the sheaths are flammable. For metallic tubular delivery systems
(i.e. bronchoscopes, laparoscopes, laryngoscopes), heating of the wall should be avoided to
minimize the risk of thermal damage to adjoining tissue.
The OPERATOR should check the proper positioning of the laser delivery fibre (or waveguide)
within the endoscope prior to releasing the beam. Means include

– 12 – TR 60825-8 © IEC:2006(E)
– checking the integrity of the aiming spot;
– introducing the fibre far enough so that the tip can be seen through the endoscope. It
should be realized that the tip of the fibre may become excessively heated during laser
transmission and may cause heat damage to the endoscope or (upon contact) to the tissue
although the aiming spot looks normal.
Care should be taken when endoscopy is performed in an oxygen enriched atmosphere.
4.3.2.4 Cleaning, disinfecting and anaesthetic agents
Any new agent used with a laser should be checked for flammability before use. The OPERATOR
should consider the use of non-flammable agents (e.g. water-based). If the use of flammable
agents cannot be avoided, time should be allowed for complete dispersal of the agent to take
place.
4.3.2.5 Drapes and covers
Sponges, gauze pads and swabs located near the operating field should be moistened with
saline or sterile water. If class 4 laser equipment is used, surgical drapes may catch fire. The
region of the drape near the operating field should be kept moistened with saline or sterile
water. However, it should be considered that the sterility can be compromised and that the
hazard of leakage current can occur.
If the laser handpiece is placed on a dry region of the sterile drape, the drape may be ignited if
the laser is accidentally operated, or if the handpiece is hot following use. This may go
unnoticed. It should, therefore, become a matter of routine either to cover the aperture with a
laser-resistant cap or to put the laser handpiece in a safe holder during a procedure pause
and/or to set the laser equipment to stand-by. The laser transmission system should never be
1)
left lying on the patient or under uncontrolled conditions. See ISO 11810-1 and ISO 11810-2 ,
4.4 Fumes, plumes and vapours
In most class 4 laser operations, the vaporization of target tissue produces noxious airborne
contaminants. The smoke plume may contain viral particles having a respiratory size of the
order of 0,1 μm.
4.4.1 Goal
Laser generated fumes, plumes and vapours should be removed from the operating environ-
ment to produce a level which is considered acceptable.
4.4.2 Control measures
4.4.2.1 Dedicated smoke evacuation systems
Masks, including special laser surgical masks, are not recommended for use as the primary
method of filtration.
Airborne contaminants should be captured as near as practicable to the source and removed
by local exhaust ventilation. The evacuation system should be designed to ensure that any
potentially infectious agents are not passed downstream in the air handling/exhaust system.
This may be accomplished with a smoke extractor using ULTRA LOW PENETRATION AIR FILTER
(ULPA) filters (at least 0,1 μm) with a filtration efficiency at this particle size of not less than
99,999 %. Local extraction of fume also eliminates cellular debris and vapours, thus providing
greater visibility for increased precision and safety.
––––––––––
1)
ISO 11810-2, to be published.
TR 60825-8 © IEC:2006(E) – 13 –
Replaceable filters should be monitored and replaced on a regular basis in accordance with the
manufacturer's recommendations.
4.4.2.2 High speed particles
Consideration should be given to protecting the eyes and the respiratory tract from particles
which may be ejected at high speed from the target site. Laser safety eyewear, if worn, can be
assumed to provide adequate protection for the eyes.
4.4.2.3 Laser plume in the patient’s respiratory system
When jet ventilation is applied during laser treatment in the upper respiratory tract, the
OPERATOR should consider that the ventilation flow may transport plume particles and gases
into the patient’s respiratory system.
4.4.2.4 Surgical suction systems
If the amounts of plume are small, surgical suction equipped with a disposable in-line filter
should be used to remove the plume from the operating site.
4.5 Collateral hazards
4.5.1 Noxious vapours
Presently, hazardous gases such as chlorine, fluorine, hydrogen chloride and hydrogen fluoride
are used in some laser systems. Care should be taken with their storage and to ensure
adequate removal of noxious vapours in the event of failure. Dyes and associated solvents are
often toxic. The manufacturer's handling recommendations should be rigorously observed
when draining or filling dye lasers. Skin contact with the fluid used and inhalation of its vapour
should be avoided. Waste material should be disposed of in an approved manner.
4.5.2 Contaminants from gas containers used in endoscopy
Bacterial contaminants and metallic residues have been found in gas cylinders and pressure
regulators. Fibre delivery systems, as well as Venturi ventilation systems, that deliver gas from
gas containers to the patient should therefore be equipped with an in-line filter to remove the
contaminants.
4.5.3 Collateral radiation and high voltages
Many lasers employ high voltage, radio-frequency or intense optical sources for excitation.
These high-energy sources can be hazardous both to personnel and other equipment, if not
shielded. Under normal conditions, modern laser systems are safe from collateral radiation and
high voltage hazards. In order to ensure this, the manufacturer's instructions should be
followed by all staff using or maintaining the laser.
4.5.4 Gas embolism
The use of gases in laser surgery in closed body cavities can lead to a risk of gas embolism in
the patient. This risk can be minimized by using carbon dioxide, if a gas is required, or by using
a fluid. In particular, it is recommended that no gas be used in small cavities.
5 Administrative procedures
5.1 LASER SAFETY OFFICER (LSO)
For installations where lasers of class 3B or class 4 are in use, the RESPONSIBLE ORGANISATION
should appoint a LASER SAFETY OFFICER (LSO) and define his/her responsibilities. The LSO
should be sufficiently knowledgeable to be able to advise the RESPONSIBLE ORGANISATION on

– 14 – TR 60825-8 © IEC:2006(E)
aspects of laser safety which relate to the lasers in use in that facility. A member of the
RESPONSIBLE ORGANISATION may assume the role of the LSO. The LSO should cooperate
directly with the operator of the equipment.
Locally, within the LASER CONTROLLED AREA, there should be a designated person, suitably
trained, who ensures that on a day-to-day basis safety measures are obeyed. The OPERATOR
may assume this role.
NOTE Medical laser equipment is frequently used in small clinics whose staff may consist of a single LASER
OPERATOR and a receptionist. This situation is found in the offices of physicians, podiatrists, dentists and others.
The requirements and principles of the safe use of such equipment in these settings are no less stringent than
when the same systems are used in large institutional settings such as hospitals. It is the responsibility of the
OPERATOR who is using the laser to be aware of the requirements for safe use. In effect, the individual professional
OPERATOR becomes responsible for consideration of the recommendations for safe use outlined in this report. The
professional should assume the administrative responsibilities of the LSO, as well as seeing that all national
regulations are met and non-governmental controls are in place. This means that he or she should be trained in
laser safety issues, and be responsible for, among others, the LASER CONTROLLED AREA and its warning signs,
proper use of protective eyewear and other safety measures both for protection of the patient and other personnel
who may be potentially exposed to hazards associated with laser use. The individual should also be responsible for
maintenance and other practices required for the safe operation of the healthcare laser equipment he or she is
using.
5.1.1 Duties and responsibilities of the LSO
5.1.1.1 Duties
The primary duty of the LSO should be to support and advise the RESPONSIBLE ORGANISATION
with respect to the safe use of lasers and protection measures.
5.1.1.2 Responsibilities
More specifically, the responsibilities of the LSO include:
a) performing a hazard assessment of laser working areas, including the determination of the
nominal hazard area; a scheme of a risk assessment should be followed (see Annex C);
b) giving advice to the administrative head and to the responsible person in the area about
safety issues when purchasing and putting into operation the laser equipment as well as
operational and occupational safety measures;
c) choosing personal protective equipment;
d) contributing to the education of employees who work with or close to lasers about the
hazards and about the safety measures;
e) contributing to the checking and approval of laser equipment according to national
regulations and verifying that the maintenance and service of the equipment are performed
by persons who have been trained for that purpose or are otherwise qualified;
f) ensuring, by repeated auditing, that the prescribed control measures are effective, e.g.
checking that personal protective equipment, laser radiation barriers and laser signs are
in place, verifying standard operating procedures, alignment procedures, peri-operative
checklists;
g) providing information to the administrative head and to the responsible person in the area
about shortcomings and failures of the laser equipment;
ACCIDENTS and INCIDENTS involving lasers, providing information (see 5.3)
h) investigating all
on preventive measures to those involved, including the dedicated safety specialists of the
facility.
Additional responsibilities may include
i) deciding about technical and organizational safety measures;
j) advising employees working with lasers or in laser areas;
k) withdrawing laser equipment from use, if necessary;
l) initiating medical investigations, if a laser ACCIDENT is reported;

TR 60825-8 © IEC:2006(E) – 15 –
m) liaising with national authorities.
5.2 Medical supervision (ophthalmic surveillance)
In the absence of national regulations, the following recommendations should be taken into
consideration.
a) The value of medical surveillance of laser workers is a fundamental problem as yet
unresolved by the medical profession. If ophthalmic examinations are undertaken, they
should be carried out by a qualified specialist and should be confined to workers using
class 3B and class 4 lasers.
b) A medical examination by a qualified specialist should be carried out immediately
(i.e. within 24 h) after an apparent or suspected injurious ocular exposure. Such an
examination should be supplemented with a full biophysical investigation of the circum-
stances under which the ACCIDENT occurred.
NOTE Specialists performing ophthalmic examinations should be aware that many retinal lesions can be
incorrectly attributed to laser damage (see Mainster, MA, Sliney, DH, Marshall, J., Warren, KA, Timberlake,
GT, Trokel, SL,” But is it really light damage?”, Ophthalmology, Vol. 104, Nr. 2, February 1997, Guest
Editorial).
c) Pre-, interim- and post-employment ophthalmic examinations of workers using class 3B and
class 4 lasers have value for medico-legal reasons only and are not a necessary part of a
safety programme.
5.3 INCIDENT and ACCIDENT reporting
5.3.1 INCIDENT reporting
Any INCIDENT or ACCIDENT arising from the use of the laser should be reported immediately to
the LSO. Further use of the laser should be suspended until the LSO has made an
investigation and taken steps to ensure that the INCIDENT or ACCIDENT cannot recur.
The LSO should carry out an investigation of any INCIDENT, develop recommendations to
prevent recurrence and supply a report to the RESPONSIBLE ORGANISATION. The latter, in
consultation with the LSO, is strongly advised to circulate the recommendations resulting from
the investigation at least to
– all other LSOs appointed by the RESPONSIBLE ORGANISATION;
– the biomedical engineering department, as appropriate.
The LSOs are advised to inform the OPERATORS and employees concerned, as appropriate.
The LSOs are also advised to keep records of all such INCIDENTS.
NOTE It is understood that any INCIDENT needs an action. Actions include the development of preventive
strategies (recommendations) and the distribution of information about the INCIDENT along with preventive
recommendations to all persons who are likely to be subjected to the same kind of danger. It is therefore strongly
recommended that INCIDENTs which have happened are not allowed to be kept secret; in order to motivate people to
freely report the situation, they should not be subjected to sanctions. INCIDENT reporting will more and more become
part of modern management techniques, e.g. in terms of quality assurance and ACCIDENT prevention. It appears
that, besides the United States FDA activity about collecting and reporting of laser INCIDENTS, very little is known
about the severity and statistics of laser INCIDENTS and ACCIDENTS. However, knowledge of INCIDENTS and
ACCIDENTS is the best basis for adequately aimed counter-measures. Therefore, a legalized standardized reporting
system is worthwhile and established in some countries.
Any INCIDENT, whether an injury occurs or not, provides valuable information from which lessons can be learnt. This
is an important part of safety management. The value of disseminating this information widely is emphasized.
5.3.2 ACCIDENT reporting
ACCIDENTS involving lasers and serious defects in the equipment which could have led to
severe injuries should be reported to the central health authority if a country-wide reporting
system is in operation.
– 16 – TR 60825-8 © IEC:2006(E)
5.3.2.1 National ACCIDENT reporting procedure
Not defined in this report.
5.3.3 Reporting scheme
Where an INCIDENT or ACCIDENT involving a laser is suspected, the LSO should prepare a report
of the circumstances. The report should contain at least the following:
a) a summary of the circumstances of the INCIDENT or ACCIDENT that led to an injury, which
should specify
1) the date, location and time,
2) the names and designations of all staff and other persons involved,
3) the details of the experience of the injured person,
4) apparent contributing factors,
5) the LSO’s recommendations to prevent a recurrence, and
6) the obvious or suspected nature of any injury sustained by the person;
b) full written statements from all persons (including the LSO and, if practicable, the OPERATOR
and/or assistants) who were engaged in the procedure
...