IEC TR 62471-3:2015

IEC TR 62471-3 ®
Edition 1.0 2015-01
TECHNICAL
REPORT
colour
inside
Photobiological safety of lamps and lamp systems –
Part 3: Guidelines for the safe use of intense pulsed light source equipment
on humans
All rights reserved. Unless otherwise specified, 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
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.

IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.

IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 60 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,

77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
IEC TR 62471-3 ®
Edition 1.0 2015-01
TECHNICAL
REPORT
colour
inside
Photobiological safety of lamps and lamp systems –

Part 3: Guidelines for the safe use of intense pulsed light source equipment

on humans
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 29.140 ISBN 978-2-8322-2207-2

– 2 – IEC TR 62471-3:2015 © IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope and object . 7
1.1 Scope . 7
1.2 Object . 7
2 Normative references. 7
3 Terms and definitions . 7
4 Responsibility for safe working conditions . 8
5 Risks from exposure to IPL optical radiation . 9
5.1 Risks to the eye . 9
5.1.1 Inadvertent eye exposure . 9
5.1.2 Treatment adjacent to the eye . 9
5.2 Skin burns. 9
5.3 Scars . 9
5.4 Hyper/hypo-pigmentation . 10
5.5 Purpura . 10
5.6 Unrecognised malignancies or premalignant conditions on the treatment site . 10
5.7 Delicate anatomy or inappropriate treatment sites . 10
5.8 Drug-induced photosensitivity . 10
5.9 Contra-indicated CLIENT conditions . 10
6 Causes of risks . 11
6.1 General . 11
6.2 Operator errors . 11
6.2.1 SKIN TYPE . 11
6.2.2 Failure to recognize contra-indicated CLIENT conditions or
photosensitizing drug use . 11
6.2.3 Incorrect or non-use of protective eyewear . 11
6.2.4 Failure to perform patch tests adjacent to the area of treatment . 11
6.2.5 Failure to maintain optical components . 11
6.2.6 Failure to use the appropriate filter . 12
6.2.7 Inappropriate or inadequate skin cooling . 12
6.2.8 Inappropriate technique . 12
6.3 Poor CLIENT compliance . 12
6.4 IPL OUTPUT variability from older equipment . 12
6.4.1 Incorrect display of the settings . 12
6.4.2 Excessive power peaks . 12
6.4.3 Uneven energy distribution . 13
6.5 Risks from other potential hazards . 13
6.5.1 Airborne contaminants . 13
6.5.2 Electrical safety . 13
6.6 Cleansing and disinfecting . 13
7 Risk assessment . 13
8 Education and training . 14
Annex A (informative)  Biological effects, SKIN TYPES . 16
A.1 Optical radiation spectrum . 16

A.2 Fitzpatrick skin classification . 16
A.3 Structure of the eye . 16
A.4 Penetration of light in the eye . 17
A.5 Structure of the skin . 17
A.6 Biological effects . 19
A.6.1 General . 19
A.6.2 Ultraviolet radiation . 20
A.6.3 Visible radiation . 21
A.6.4 IR-A . 21
A.6.5 IR-B . 22
A.6.6 IR-C . 22
Annex B (informative) Personal eye protection . 23
Annex C (informative)  IPL technology, classification . 24
Annex D (informative) Warning sign . 25
Annex E (informative) . 26
E.1 Local rules . 26
E.2 Sample template . 26
Bibliography . 30

Figure A.1 – Structure of the eye . 17
Figure A.2 – Penetration of different wavelengths through the eye . 17
Figure A.3 – The structure of the skin . 18
Figure A.4 – Penetration of different wavelengths through the skin. 18
Figure A.5 – Absorption of skin main chromophores, log scale, arbitrary units . 19
Figure D.1 – Warning symbol for use with IPL equipment . 25

Table A.1 – Division of the optical radiation spectrum . 16
Table A.2 – Fitzpatrick Classification Skin Type Scale . 16
Table A.3 – Biological effects of optical radiation to the eye and skin . 19
Table C.1 – Classification of risk group (IEC 62471) . 24

– 4 – IEC TR 62471-3:2015 © IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS –

Part 3: Guidelines for the safe use of intense pulsed light
source equipment 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 itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
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/TR 62471-3, which is a technical report, has been prepared by IEC technical committee
76: Optical radiation safety and laser equipment.

The text of this technical report is based on the following documents:
Enquiry draft Report on voting
76/497/DTR 76/505/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.
In this technical report, terms printed in SMALL CAPITALS are used as defined in Clause 3.
A list of all parts in the IEC 62471 series, published under the general title Photobiological
safety of lamps and lamp systems, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability 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 publication may be issued at a later date.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct
understanding of its contents. Users should therefore print this document using a
colour printer.
– 6 – IEC TR 62471-3:2015 © IEC 2015
INTRODUCTION
This technical report describes possible adverse incidents that may occur in respect of the
use of IPL devices and recommends measures to avoid them. Some of the described
incidents represent serious adverse effects, ranging from cosmetically significant to physically
or medically significant. Provided the IPL operator is appropriately educated and trained and
the guidelines in this document are followed, the use of IPL in a cosmetic setting should be no
more hazardous to the CLIENT or staff personnel than similar IPL interventions in medical
settings.
PHOTOBIOLOGICAL SAFETY OF LAMPS AND LAMP SYSTEMS –

Part 3: Guidelines for the safe use of intense pulsed light
source equipment on humans
1 Scope and object
1.1 Scope
This part of IEC 62471, which is a technical report, provides guidelines for the safe use of
INTENSE PULSED LIGHT (IPL) source equipment in professional premises.
This technical report sets out the control measures recommended for the safety of recipients
of IPL treatment, staff, service, maintenance personnel and others. Engineering controls
which form part of the IPL equipment or the installation are also briefly described to provide
an understanding of the general principles of protection.
1.2 Object
The object of this report is to provide information which helps to protect persons from
hazardous exposure to optical radiation and other associated hazards by providing guidance
on how to establish safety measures and procedures.
NOTE Although the manufacturers provide treatment information in their instructions for use, such information
may not be exhaustive or applicable to all CLIENT treatment conditions.
If IPLs are applied to patients in medical premises, the physician is deemed to be responsible
for all medical aspects of the treatment including his or her decisions about questions of
indication and contraindication such as found in Clauses 5 and 6.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. 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.
3.1
CLIENT
person receiving the IPL treatment
EXAMPLE Customers in beauty salons or patients in medical environments.
3.2
CONTROLLED AREA
area around the IPL where the local rules apply
Note 1 to entry: Generally the room where the IPL is used.

– 8 – IEC TR 62471-3:2015 © IEC 2015
3.3
INTENSE PULSED LIGHT
IPL
equipment, containing a flash lamp, e.g. xenon or krypton, housed in a handheld device,
having an emission window with an area of several cm , typically providing a filter which
restricts the emission to a band in the visible and infra-red
Note 1 to entry: Pulse lengths are in the order of tens of ms or less and pulse repetition rates are typically two per
second or less. The IPL OUTPUT is in the order of up to 50 J/cm . The wavelengths range typically from 400 nm
to1 200 nm.
Note 2 to entry: “IPL” may be covered by trademark rights in certain countries. Generally, users and recipients of
IPL treatment comprehend the generic meaning of “IPL” as intense pulsed light.
3.4
IPL OUTPUT
radiant exposure measured at the IPL emission window, as received by the human skin in
contact mode application
Note 1 to entry: The IPL output is expressed in J/cm .
Note 2 to entry: The erroneous term “fluence” is found in some brochures or in the instructions for use.
3.5
OCULAR HAZARD DISTANCE
OHD
radial distance from the emission window of an IPL within which the applicable exposure limit
value to the unaided and non-protected eye is exceeded
3.6
RESPONSIBLE PERSON
person who is made responsible for assessing the risks of IPLs, determining the safety
measures and the local rules, either the owner/operator of the facility or a person upon
appointment by the owner/operator
3.7
SKIN TYPE
Fitzpatrick skin type
Note 1 to entry: Refer to literature about Fitzpatrick SKIN TYPES.
Note 2 to entry: SKIN TYPE varies with pigmentation and sensitivity to UV and also to visible light. Different SKIN
TYPES will respond differently to light exposure. In particular, darker SKIN TYPES are more likely to develop
hyperpigmentation following light exposure.
4 Responsibility for safe working conditions
Generally, the owner/operator or RESPONSIBLE PERSON of the facility, where IPLs are used, is
deemed responsible for all decisions which are related to safety. The owner or operator of the
facility may appoint another competent or knowledgeable person who then deals with safety
issues on behalf of the owner or operator of the facility. Hence either the owner/operator of
the facility or the appointed competent person assumes responsibility for the conditions
necessary to safely apply the IPL, called the RESPONSIBLE PERSON. It is recommended that the
responsibilities are clearly allocated. Only one RESPONSIBLE PERSON should be appointed
within a facility.
All employees of the facility should know who the RESPONSIBLE PERSON is, in order to be able
to consult him or her when safety issues arise.
NOTE The RESPONSIBLE PERSON may be seen in analogy with the laser safety officer, who is in charge of safety
when high power lasers are used.

5 Risks from exposure to IPL optical radiation
5.1 Risks to the eye
5.1.1 Inadvertent eye exposure
Permanent eye damage resulting in loss of vision can occur when the handpiece is directed to
the face of any person and the IPL is fired inadvertently. The OHD (OCULAR HAZARD DISTANCE)
could be in the range of 0,5 m, but the actual distance according to IEC 62471 as available
from the manufacturer should be considered. A direct eye exposure should under all
circumstances be avoided, for example by the use of IPL protective eyewear, see Annex B.
Transient flash blindness, dazzling or after images may occur as a result of specular or
diffuse reflection especially from the treatment area, be it inadvertent or during regular use.
The level of the ambient light should be chosen as bright as possible. This normally reduces
the aperture of the eye’s pupils allowing less light to enter the eye.
Some users choose not to wear safety glasses but instead temporarily close their eyes when
they fire the IPL, so that the flashes are not seen. This should not be regarded as a safe
procedure.
5.1.2 Treatment adjacent to the eye
Except for chronic effects related to frequent exposures, the CLIENT is subject to the same
risks as the operator.
In addition if the treatment site is close to the eyes or on the eyelid, then the heat produced
by the IPL may cause clinical problems ranging from iritis up to serious damage to the iris
which may be permanent. The damage may lead to the loss of the contractibility of the iris
because the muscle cells within the iris are seriously damaged or destroyed. The iris may no
longer be circular and the iris colour may change or may become de-pigmented.
When treating the face with an IPL, always use occlusive IPL eyewear.
If treatments are conducted within the orbital rim, then intraocular metal shields and the
appropriate medical lubricant should be utilized.
5.2 Skin burns
Skin burn to the client is a major risk. Skin injury may result from excessive high dose, skin
pigmentation, failure or lack of cooling of the skin, presence of a tan, inappropriate selection
of the wavelength band of the light and of pulse parameters. The skin has varying sensitivity
at different locations on the body. It depends on the skin colour, the skin thickness and
contour.
Skin burn injuries can range from mild erythema, which may be an expected side effect, to
blistering. Although first degree burns normally heal without permanent effects such as
hyperpigmentation, hypopigmentation and scarring, second degree burns will occasionally
result in scars and third degree burns will regularly result in permanent scars. Secondary
effects of burns may follow such as infections, triggering of herpes, hyperpigmentation and
hypopigmentation.
5.3 Scars
Some CLIENTS develop hypertrophic scarring/keloids after IPL treatment, others do not.
CLIENTS should be screened for history of hypertrophic keloids and scarring prior to
consideration for IPL treatment.

– 10 – IEC TR 62471-3:2015 © IEC 2015
5.4 Hyper/hypo-pigmentation
Unexpected hyperpigmentation can result from IPL treatment inducing increased pigment
production by the melanocytes. In most cases, this effect is transient, in other cases it lasts
for several months or can be permanent. Occasionally an injured area can result in long
lasting hypopigmentation, which may be permanent.
5.5 Purpura
Purpura is a purple red discoloration due to rupture of small vessels. This may be an
unacceptable side effect and could be a result of IPL treatment with inappropriate dosage.
The effects are often transient.
5.6 Unrecognised malignancies or premalignant conditions on the treatment site
The presence of premalignant lesions or malignant lesions is contraindicated to IPL treatment.
Failure to recognise this presents a serious risk to the CLIENT. Some skin lesions can lead to
pre-malignant lesions progressing to malignancy, existing malignant lesions becoming more
aggressive and making histological examination more difficult. Subsequent medical treatment
of the condition may also be compromised. As for any aesthetic skin treatment, this concern
should be understood in a general manner, as any unidentified disease should be excluded by
medical specialist examination prior to IPL treatment.
5.7 Delicate anatomy or inappropriate treatment sites
The sensitivity of the skin to IPL radiation varies considerably due to the location, thickness of
the skin, bone and bony prominences. For instance, off-face locations may require more
conservative (lower) settings than locations on the face.
5.8 Drug-induced photosensitivity
Prior treatment with specific photosensitizing drugs such as antibiotics, herbal supplements
and isotretinoin can induce sensitivity to UV and visible light. Although most IPLs block the
UV and the blue from the IPL OUTPUT, the remaining visible output may cause unexpected
outcomes such as burns and delayed wound healing. An interval of at least 6 months should
be observed after the last dose of isotretinoin has been taken. Waiting times for drugs other
than isotretinoin are variable. The user should check with the CLIENT’s medical practitioner for
advice.
5.9 Contra-indicated CLIENT conditions
Conditions which should be considered prior to undertaking IPL procedures include but are
not limited to:
– presence or history of skin cancer;
– presence or history of systemic infections or diseases such as herpes simplex, systemic
lupus, diabetes;
– recent natural, sunbed/solarium or chemical tanning;
– treatment over tattoos;
– current treatment with any photosensitizing drug, see 5.9;
– dark SKIN TYPE;
– immunosuppressive diseases, including AIDs and HIV infections and/or use of
immunosuppressive drugs;
– history of keloid and scarring;
– history of bleeding disorders or use of anticoagulants;
– pregnancy or nursing;
– history of epileptic disorder.

NOTE 1 Some manufacturers do not recommend the use of IPL on pregnant and nursing women. However, it
seems that there is currently no scientific evidence for pregnancy or nursing to be a contraindication.
NOTE 2 Some national regulations classify epilepsy as a contraindication for IPL treatment. However it seems
that there is up to now no scientific evidence supporting the occurrence of epilepsy or seizure disorders being
caused by IPL treatment at typical flash repetition rates of one pulse per second or less. CLIENTS with suspected
epileptic disorder may be considered for use of opaque eye shielding.
6 Causes of risks
6.1 General
The causes of risks specified in 6.2 should be considered when the risks are assessed. Safety
measures should be chosen so that these risks are minimised. See Clause 7. Additional risks
may be necessary to be considered for particular uses of IPLs or for different settings.
6.2 Operator errors
6.2.1 SKIN TYPE
Operator error may result in either expected treatment-related side effects or unexpected
complications and adverse effects:
– SKIN TYPE not considered;
– SKIN TYPE not determined correctly;
– energy setting of the IPL not corresponding to the SKIN TYPE in the area of treatment
although the SKIN TYPE was correctly assessed;
– any error which may result in over-dosage leading to adverse incidents or under-dosage
causing ineffective or sub-optimal treatment.
6.2.2 Failure to recognize contra-indicated CLIENT conditions or photosensitizing
drug use
The CLIENT was not correctly screened or questioned regarding the presence of existing
medical conditions or pharmaceutical/herbal supplement use which may be relevant for the
safety of the treatment.
The operator not being able to recognize skin lesions like possible pre-malignancies, thus
ignoring contraindicating situations.
6.2.3 Incorrect or non-use of protective eyewear
Incorrect eyewear, or non-use of appropriate eyewear may result in ocular injury to client or
other persons.
6.2.4 Failure to perform patch tests adjacent to the area of treatment
The operator is not performing a test exposure and is not assessing the outcome, where
necessary, to exclude excessive skin reactions. Patch tests should not be overly aggressive.
Pulse-stacking should be avoided. The reaction of the tissue can change from day to day. The
user should observe the reaction and should adjust the treatment parameters accordingly.
6.2.5 Failure to maintain optical components
If the following manufacturer’s device maintenance and operating instructions are not
observed, then damage to equipment or incorrect treatment may occur:
– optical IPL OUTPUT window not kept clean;
– damage to the optical window or filters not recognized;
– optical system not calibrated (according to the manufacturer’s instructions);

– 12 – IEC TR 62471-3:2015 © IEC 2015
– coupling gel not properly applied if the use of gel is recommended by the manufacturer;
– possibility of IPL OUTPUT increase following replacement of the lamp has not been taken
into consideration;
– disregard of the manufacturer's recommended lamp life.
6.2.6 Failure to use the appropriate filter
The filter used is not appropriate for the SKIN TYPE and/or for the intended application.
6.2.7 Inappropriate or inadequate skin cooling
No cooling is provided at all or the means of cooling used is different from the manufacturer’s
recommendations. Since the cooling protects the epidermis, failure or deficiency of cooling
increases the risk of damaging the epidermis.
6.2.8 Inappropriate technique
The settings of the IPL (pulse duration, energy, filtering, etc.) deviate from the settings which
are recommended by the manufacturer according to the actual treatment procedure.
Unsuitable overlapping of the irradiated areas will cause over-dosage in the zone of overlap,
as the produced heat provides accumulated heat in that overlap area.
The interval between consecutive exposures on overlapping areas is too short, not allowing
the tissue to cool down during the interval.
Elapsed time between treatment sessions is too short, leading to inadequate tissue recovery
from the preceding treatment session.
6.3 Poor CLIENT compliance
Adverse effects may be caused by the CLIENT not complying with the agreed pre and post
treatment protocols, for example active tan, sun-bed use, sun exposure, skin care, etc.
6.4 IPL OUTPUT variability from older equipment
6.4.1 Incorrect display of the settings
Some IPL equipment may show discrepancies between the display of settings and the actual
2 2
IPL OUTPUT. If for instance the display shows 20 J/cm and the actual IPL OUTPUT is 24 J/cm ,
the user is misguided and an overdose will occur. The user should be aware of this possibility.
NOTE As IPL devices are in most cases not self-calibrating, the factory calibration of a particular energy density
setting will normally reflect a ‘mid value’ for the applicator handpiece. For a new applicator, the actual output will
probably be up to 20 % above the device displayed value and by the end of the normal lifetime of the applicator,
the energy will probably be 20 % below the displayed value.
6.4.2 Excessive power peaks
Old equipment designs may deliver pulse shapes including excessive power peaks at the
beginning of the pulse whereas newer IPL equipment delivers a rather flat power distribution
over the pulse. The tissue reaction is not the same although the total energy may be identical.
Although one would expect mixed effects resulting from a combination of a short pulsed and
of a long pulsed IPL it is not easy to predict the outcome. If in doubt, the user should consult
the manufacturer,
6.4.3 Uneven energy distribution
Some older equipment designs may exhibit significant variation of the energy distribution over
the window area, which may cause burns from highly localized excessive energy deposition
adjacent to areas where the desired effect is not achieved.
6.5 Risks from other potential hazards
6.5.1 Airborne contaminants
Because vaporized cosmetics and hair breakdown products and other airborne contaminants
may result from some procedures, the worksite should be well ventilated.
6.5.2 Electrical safety
Many IPL systems employ high voltage sources. Under normal conditions, IPL systems do not
present a high voltage risk, but it is imperative for all personnel to follow manufacturer’s
instructions when using or maintaining the equipment.
6.6 Cleansing and disinfecting
Infectious particles or contamination may be transferred from one CLIENT to the other, when
the applicator’s surface is not cleaned and disinfected during the interval between treatments.
Cleaning or disinfectant agents should be used according to the manufacturer’s
recommendations. Care should be taken not to use cleaning agents that might damage optical
coatings of the equipment. Similarly, routine precautions should be taken to clean and
disinfect CLIENT protective eyewear, especially ocular shields, to prevent cross-contamination
between CLIENTS.
7 Risk assessment
The user should assess the risks involved with the use of IPLs. A clear distinction should be
made between risks for the user/personnel and risks for the CLIENT. The risk assessment
should be documented. It should list the risks including the hazards. Safety measures should
be derived and added to the documented risks, which ensure that injuries are prevented and
side-effects minimized.
In order of importance (hierarchy), as a general safety rule, avoidance of emission is ranked
highest (if the intended effect can be achieved by technically different and safer means),
followed by reduction of intensity, limitation of the propagation, reducing the on-time, limiting
the number of persons involved, and using personal protective equipment.
When using IPLs, the measures applicable to avoid hazards to inadvertent eye exposure to
IPL emission would be:
label the treatment room with clearly visible warning signs indicating use of IPL;
use movable partitions; orient the user and the CLIENT so that the potential action range of the
emitted flashes is directed towards the nearby wall or partition rather than towards other
persons, a door or a window;
use window shielding; shorten the on-time, use the stand-by-mode, prevent people from
entering the IPL work zone;
control access to the IPL equipment and to the IPL equipment key;
employ local rules, make them known to everybody in the environment of the IPL. A template
of the local rules is given in Annex E;
limit access to the IPL to trained personnel;
make personal protective equipment available at a given location; provide rules on how to
check, use and maintain equipment;

– 14 – IEC TR 62471-3:2015 © IEC 2015
maintain appropriate documentation including policies and procedures, incident reporting and
incident follow-up, audit reports, chart review and case reports.
The measures applicable to avoid skin injuries would be:
− assess the intended treatment area (refer to Clause 5);
− use the least possible power or energy to achieve the desired result;
− in view of the fact that personal skin protection is not feasible, if the least possible energy
setting still causes intolerable side effects, the IPL must not be used for this type of
application.
Management and control measures should include:
– personnel who are qualified to use the IPL;
– education and training (see Clause 8);
– safe usage protocol (written description of the procedures, including revision and/or
audits);
– preparation of the treatment room;
– provisions for protective eyewear;
– calibration and equipment testing;
– service and maintenance procedures;
– protocols in the event of incidents (see Clause 5), including referral to appropriate medical
care;
– preventive actions to be taken;
– documentation of every treatment case, including incremental treatment parameters;
– incident reporting procedure.
NOTE Documentation of every treatment case provides a learning opportunity, since documentation allows the
user to keep track of the cases, of the CLIENT personal data, of IPL use parameters, treatment success and
failures, incidents and near-incidents.
8 Education and training
Education should be on-going and knowledge be kept up to date. As technology (including
equipment software updates) or treatment modalities change, additional training may be
necessary.
Providers of education and training should be suitably qualified.
Unless training is defined by the national regulatory authority, the user should assess the
quality and relevance of IPL training offerings according to the criteria below.
Education should include:
– fundamentals of how IPL devices and delivery systems work;
– wavelengths of light and bio-effects, tissue interactions;
– skin typing;
– risk assessment and hazard identification;
– basics of safety and applicable standards;
– CLIENT assessment, follow up and management of complications;
– appropriate and acceptable clinical applications;
– conditions to be considered prior to IPL application;
– CLIENT education and preparation;

– procedural operations and staff responsibilities;
– discharge planning including CLIENT instructions and support measures;
– documenting and reporting.
Training should include:
– practical application of the recommendations of the safety standards;
– room set-up, equipment positioning;
– use of engineering controls, operation, handling and testing of the equipment;
– selecting the dose and assessing IPL’s effects on tissue;
– CLIENT preparation and positioning;
– application techniques;
– cleaning and care of all equipment;
– safe and professional conduct during procedures.

– 16 – IEC TR 62471-3:2015 © IEC 2015
Annex A
(informative)
Biological effects, SKIN TYPES

A.1 Optical radiation spectrum
The optical radiation spectrum is generally divided up, by wavelength, as given in Table A.1:
Table A.1 – Division of the optical radiation spectrum
Ultraviolet “C” (UV-C) 100 nm – 280 nm
Ultraviolet “B” (UV-B) 280 nm – 315 nm
Ultraviolet “A” (UV-A) 315 nm – 400 nm
Visible light 400 nm – 700 nm
Infrared “A” (IR-A) 700 nm – 1 400 nm
Infrared “B” (IR-B) 1 400 nm – 3 000 nm
Infrared “C” (IR-C)
3 000 nm – 1 000 000 nm (3 µm – 1 mm)

A.2 Fitzpatrick skin classification
The Fitzpatrick Classification Scale (see Table A.2) was developed in 1975 by Harvard
Medical School dermatologist, Thomas Fitzpatrick. This scale classifies a person's tolerance
of sunlight. It is used by many practitioners to determine how someone’s skin will respond to
UV or light exposure.
Table A.2 – Fitzpatrick Classification Skin Type Scale
Skin colour Characteristics
I Very fair, red or blond hair, blue eyes, freckles Always burns, never tans
II White, fair, red or blond hair, blue, hazel, or green eyes Usually burns, tans with difficulty
III Cream white, fair with any eye or hair colour, very Sometimes mild burn, gradually tans
common
IV Brown, typical Mediterranean caucasian skin Rarely burns, tans with ease
V Dark Brown, mid-eastern skin types Very rarely burns, tans very easily
VI Black Never burns, tans very easily

A.3 Structure of the eye
The basic anatomical structure of the eye is shown in Figure A.1

Iris
Lens
Fovea
Pupil
Cornea
Retina
Optic
nerve
IEC
Figure A.1 – Structure of the eye
A.4 Penetration of light in the eye
As shown in Figure A.2, visible and IR-A optical radiation entering the eye passes through the
cornea, aqueous humour, then through a variable aperture (pupil), and through the lens and
vitreous to be focused on the retina. With respect to the other wavelength ranges, radiation of
UV-C, UV-B, most of UV-A, IR-B and IR-C incident on the eye are absorbed at various depths
by the anterior segments of the eye, thus blocking their propagation onto the retina.
UVC
UVB
UVA
Visible
IRA
IRB
IRC
IEC
Figure A.2 – Penetration of different wavelengths through the eye
A.5 Structure of the skin
The basic structure of the skin is shown in Figure A.3, and penetration of light through the
skin in Figure A.4.
The outer layer of the skin, the epidermis, contains mainly keratinocytes (squamous cells)
which are produced in the basal layer and rise to the surface to be sloughed off. The dermis is
composed mainly of collagen fibres and contains nerve endings, sweat glands, hair follicles
and blood vessels.
– 18 – IEC TR 62
...