ISO/TR 22463:2019

Patient and client eye protectors for use during laser or intense light source (ILS) procedures - Guidance

This document gives guidelines for and provides information to employers, users and safety advisors on the selection and use of patient eye protectors (PEPs) for lasers and intense light source (ILS) equipment used for medical and cosmetic applications. This document does not apply to the eye protection of laser/ILS operators or users of the equipment. It also does not apply to PEPs for use with tanning equipment or ophthalmic instruments, either for the user/operator or the patient/client.

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General Information

• Status: Published
• Publication Date: 16-Apr-2019
• ICS: 13.340.20 - Head protective equipment
• Technical Committee: ISO/TC 94/SC 6 - Eye and face protection
• Drafting Committee: ISO/TC 94/SC 6/JWG 1 - Joint ISO/TC 94/SC 6-IEC/TC 76 WG: Requirements for eye and face protection against laser radiation
• Current Stage: 6060 - International Standard published
• Start Date: 17-Apr-2019
• Completion Date: 13-Dec-2025

Relations

• Consolidated By: ISO/TS 21911-2:2022 - Solid recovered fuels - Determination of self-heating - Part 2: Basket heating tests
• Effective Date: 06-Jun-2022

Overview

ISO/TR 22463:2019 provides guidance on the selection and use of patient eye protectors (PEPs) for medical and cosmetic procedures that use lasers or intense light sources (ILS). It helps employers, safety advisors and clinical users perform risk assessments and choose appropriate eye protection to reduce ocular hazards (retinal damage, photophobia, pupillary distortion) during procedures in the face, neck and body. The report focuses on patient/client protection only - it does not cover eye protection for equipment operators, nor PEPs for tanning or ophthalmic instruments.

Key Topics

• Scope and exclusions: PEPs for patients/clients during laser/ILS procedures; excludes operator protection and tanning/ophthalmic use.
• Definitions: Key terms such as PEP, ILS, IPL, Class 1C, MPE (maximum permissible exposure), optical density (OD), stray optical radiation and Bell’s phenomenon.
• Risk assessment: Guidance for the responsible person or LSO/ILSSO to assess whether device output can exceed MPE/EL and to consider wavelength, delivery system, positioning, body location and treatment intent.
• Selection criteria:
  • Ensure good fit to prevent light leakage around the periorbital area.
  • Choose opaque or appropriately attenuating PEPs (sufficient OD across relevant wavelengths).
  • Select PEPs with resistance to intense radiation expected during treatment.
  • Account for topical compounds and metallic items (piercings) that may affect reflections.
• Usage conditions: Different recommendations depending on treatment location - below face/neck, face/neck (non-periorbital), periorbital region, and eyelid procedures.
• Labelling and administrative procedures: Requirements for labelling (where applicable) and local protocols to ensure safe use.
• Informative annexes: Annex A (reported injuries/incidents) and Annex B (commercially available PEP types).

Applications and Users

Who uses ISO/TR 22463:2019:

• Medical and cosmetic clinic owners/operators
• Laser/ILS users and assistants
• Laser/ILS safety officers and safety advisors
• Occupational health professionals and regulators

Practical uses:

• Developing local safety protocols and patient-protection procedures
• Selecting appropriate PEP types (opaque inserts, adhesive shields, molded eye cups)
• Training staff on fit checks, light-leak inspection and pre-treatment risk controls

Related Standards

• IEC/TR 60825-8 (lasers) - guidance on laser safety
• IEC/TR 62471-3 (ILS) - photobiological safety guidance
• IEC 60825-14, ISO 12609-1 / ISO 12609-2 - additional guidance for operator and device safety

Keywords: ISO/TR 22463:2019, patient eye protectors, PEP, laser safety, ILS protection, optical density, MPE, periorbital protection, risk assessment.

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 22463
First edition
2019-04
Patient and client eye protectors
for use during laser or intense light
source (ILS) procedures — Guidance
Reference number
©
ISO 2019
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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Published in Switzerland
ii © ISO 2019 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Risk assessment and selection of patient/client eye protectors . 3
4.1 General . 3
4.2 When the laser/ILS is used on parts of the body below the face/neck . 4
4.3 When the laser/ILS is used on the face/neck, but not in the periorbital region . 4
4.4 When the laser/ILS is used in the periorbital region . 4
4.5 When the laser/ILS is used on the eyelid . 5
5 Labelling . 6
6 Administrative procedures . 6
Annex A (informative) Reported injuries and incidences . 7
Annex B (informative) Types of commercially-available PEPs . 9
Bibliography .11
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 94, Personal safety — Personal protective
equipment, Subcommittee SC 6, Eye and face protection in close cooperation with IEC/TC 76, Optical
radiation safety and laser equipment.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

Introduction
Significant eye injuries to patients have been reported in the literature, to national regulatory bodies
and in anecdotal reports associated with laser or intense light sources (ILSs) when used in the vicinity
of the eye (see Annex A). Such injuries include pupillary distortion, temporary and permanent vision
impairment, temporary photophobia and eye pain, ocular fatigue and retinal damage. Many of the
reports appear to be associated with a lack of knowledge and understanding by users, and a lack of
administrative controls.
Eye protectors are available for patients undergoing procedures involving laser sources or ILS. Some
guidance with respect to such eye protectors is given in this document.
This document could be helpful for the responsible person during the process of assessing risks related
to eye safety of patients/clients. It may be consulted when setting up a protocol for the purpose of
providing safe working conditions and procedures. For further information, see also IEC/TR 60825-8,
IEC/TR 60825-14, IEC/TR 62471-3 and ISO 12609-2.
TECHNICAL REPORT ISO/TR 22463:2019(E)
Patient and client eye protectors for use during laser or
intense light source (ILS) procedures — Guidance
1 Scope
This document gives guidelines for and provides information to employers, users and safety advisors
on the selection and use of patient eye protectors (PEPs) for lasers and intense light source (ILS)
equipment used for medical and cosmetic applications.
This document does not apply to the eye protection of laser/ILS operators or users of the equipment. It
also does not apply to PEPs for use with tanning equipment or ophthalmic instruments, either for the
user/operator or the patient/client.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
Class 1C laser product
laser product that is designed explicitly for contact application to the skin or non-ocular tissue and where:
— during operation, ocular hazard is prevented by engineering means, i.e. the accessible emission is
stopped or reduced to below the accessible emission limit (AEL) of Class 1 when the laser/applicator
is removed from contact with the skin or non-ocular tissue;
— during operation and when in contact with skin or non-ocular tissue, irradiance or radiant exposure
levels exceed the skin MPE (3.7) as necessary for the intended treatment procedure;
— the laser product complies with applicable vertical standards.
Note 1 to entry: Lasers used in contact mode on the skin that incorporate safety means to ensure that good
contact is provided when the laser is emitting and that hazardous leakage radiation is inhibited, as specified in a
vertical safety standard, can be classified laser Class 1C.
[SOURCE: IEC 60825-1:2014, 3.19, modified — The three notes (which discussed the classification
scheme and tests) have been replaced by a single Note 1 to entry.]
3.2
exposure limit
EL
level of exposure to the eye or skin that is not expected to result in adverse biological effects
[SOURCE: IEC 62471:2006, 3.8]
3.3
intense light source
ILS
device incorporating one or more non-laser sources of optical radiation of the wavelength range 250 nm
to 3 000 nm and intended for creating biological effects in humans
Note 1 to entry: ILS may incorporate continuously emitting or pulsed xenon lamps, incandescent lamps, LEDs or
similar.
[SOURCE: ISO 12609-1:2013, 3.4, modified — The phrase “and animals” has been deleted from the
definition. Note 1 to entry has been expanded to include examples of light sources.]
3.4
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 that 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 on the order of up to 50 J/cm . The wavelengths range typically from 400 nm to
1 200 nm. Filters may be incorporated or attachable that cut off portions of the spectrum such as blue-green or IR.
Note 2 to entry: IPL can be covered by trademark rights in certain countries. Generally, users and recipients of
IPL treatments comprehend the generic meaning of “IPL” as “intense pulsed light”.
[SOURCE: IEC/TR 62471-3:2015, 3.3, modified — The last sentence in Note 1 to entry has been added.]
3.5
laser/ILS user
person who uses the laser/ILS equipment and in general controls the application of the laser/ILS
radiation at the working area
Note 1 to entry: The laser/ILS user may appoint other person(s), who assist(s) with the selection and/or setting
of the parameters.
[SOURCE: IEC/TR 60825-8:2006, 3.7, modified — The term has been changed from “operator” to “user”
and ILS has been added.]
3.6
laser or ILS safety officer
LSO/ILSSO
person who is knowledgeable in the evaluation and control of laser/ILS hazards and has responsibility
for oversight of the control of laser/ILS hazards
Note 1 to entry: The LSO/ILSSO may be the responsible person (3.11). The acronym “ILSSO” was created for ease
of use in this document to provide a parallel definition to that of “LSO” in cases where the risks of intense light
sources (3.3) are being assessed.
[SOURCE: IEC/TR 60825-8:2006, 3.8, modified — “ILSSO” and Note 1 to entry have been added.]
3.7
maximum permissible exposure
MPE
maximum level of laser radiation to which, in normal circumstances, the skin or eye may be exposed
without suffering adverse effects
[SOURCE: IEC/TR 60825-8:2006, 3.9, modified — In the definition, “that level” has been changed to
“maximum level” and “laser” has been added. The note has been removed.]
2 © ISO 2019 – All rights reserved

3.8
optical density
OD
D(λ)
logarithm to the base 10 of the reciprocal of the spectral transmittance, τ(λ)
Note 1 to entry: Optical density is expressed by the formula:
D(λ) = log [1/τ(λ)]
Note 2 to entry: For example, when the attenuation value is 1/100, the transmittance = 0,01 and the OD is 2.
−5
When the value is 1/100 000, the transmittance = 10 and the OD is 5.
[SOURCE: ISO 4007:2018, 3.10.1.21, modified — Note 2 to entry has been added.]
3.9
patient
person receiving laser or ILS (3.3) treatment
Note 1 to entry: “Patient” includes clients or customers in aesthetic clinics or beauty salons.
3.10
patient eye protector
PEP
eye protector meant to be worn by a patient (3.9) or client during laser or ILS (3.3) treatment
3.11
responsible person
person who is designated to assess the risks of lasers or ILS (3.3) equipment and to determine the safety
measures and the local rules
Note 1 to entry: The responsible person will be either the owner/operator of the facility or a person appointed by
the owner/operator.
[SOURCE: IEC/TR 62471-3:2015, 3.6, modified — In the definition, “IPL” has been replaced by “lasers or
ILS equipment” and who the responsible person will be has been moved to a note to entry.]
3.12
stray optical radiation
optical energy that is unintentionally emitted from the applicator, including scattered, reflected and
leakage radiation
[SOURCE: IEC 60335-2-113:2016, 3.107]
4 Risk assessment and selection of patient/client eye protectors
4.1 General
The primary goal of the LSO/ILSSO and/or the responsible person should be to conduct a risk assessment
and provide guidance for control measures to reduce ocular risks associated with usage of laser/ILS
devices. A risk assessment should be conducted to determine if the output of a laser/ILS device could
exceed the MPE/EL and potentially injure a patient/client. The risk assessment should also consider the
wavelength(s), the delivery system being used with the laser/ILS device, positioning, the intended use
and the body location of the treatment. If there is a risk of ocular injury, then appropriate eye protectors
for the patient/client should be selected that are resistant to the energy levels anticipated during the
treatment. International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidance or that
contained in national regulations may be used to assist in risk assessment.
The PEP should be labelled, if applicable, and conform to the relevant standards. Additional guidance
about the safe usage of laser and ILS equipment can be found in IEC/TR 60825-8 (lasers) or IEC/
TR 62471-3 (ILS).
NOTE If it is determined that there is additionally a potential risk to the user or staff member, refer to
ISO 12609-1 and ISO 12609-2 for ILS, and IEC 60825-14 for lasers, for guidance on the selection of eye protection
for these individuals.
4.2 When the laser/ILS is used on parts of the body below the face/neck
This is the least restrictive condition and the PEP used for the patient/client can be identical to that
worn by the user. To avoid accidental exposure if the laser/ILS beam is inadvertently directed towards
the eyes, the user should ensure that the PEP maintains a good fit with the periorbital region. The user
should check for light leakage around the edges of the PEP once it is in place to ensure a good fit. In
some cases, a close-fitting PEP may be required in place of an operator style PEP due to the particular
treatment being performed away from the head and neck or the behavioural characteristics of the
patient/client.
If the patient/client does not need or want to observe the procedure, then the PEP may be opaque (non-
transparent) and have an appropriate attenuation over the wavelength region of concern.
If any topical compound is applied to the skin that could increase the specular reflection of laser/ILS
radiation, then this should be taken into consideration when deciding on the appropriate attenuation of
the PEP. Also, any metallic items near the application site, such as piercings, should be removed prior to
laser treatment.
The resistance of the PEP to intense radiation is also less critical in this situatio
...