Photobiological safety of lamps and lamp systems - Part 3: Guidelines for the safe use of intense pulsed light source equipment on humans

IEC TR 62471-3:2015(E) which is a technical report, provides guidelines for the safe use of intense pulsed light (IPL) source equipment in professional premises. It describes possible adverse incidents that may occur in respect of the use of IPL devices and recommends measures to avoid them. IEC TR 62471-3:2015 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.

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Status
Published
Publication Date
19-Jan-2015
Current Stage
PPUB - Publication issued
Start Date
20-Jan-2015
Completion Date
20-Jan-2015
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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
IEC TR 62471-3:2015-01(en)
---------------------- Page: 1 ----------------------
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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

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

® Registered trademark of the International Electrotechnical Commission
---------------------- Page: 3 ----------------------
– 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

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IEC TR 62471-3:2015 © IEC 2015 – 3 –

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

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– 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

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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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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.
---------------------- Page: 6 ----------------------
IEC TR 62471-3:2015 © IEC 2015 – 5 –
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.
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– 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.
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IEC TR 62471-3:2015 © IEC 2015 – 7 –
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.
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– 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.
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IEC TR 62471-3:2015 © IEC 2015 – 9 –
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.
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– 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.
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IEC TR 62471-3:2015 © IEC 2015 – 11 –

NOTE 1 Some manufacturers do not recommend the use of IPL on pregnant and nursing wo

...

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