SIST EN ISO 12609-1:2025

SLOVENSKI STANDARD
01-september-2025
Varovanje oči in obraza pred intenzivnimi viri svetlobe pri ljudeh in živalih za
uporabo v kozmetiki in medicini - 1. del: Specifikacija za proizvode (ISO 12609-
1:2021)
Eye and face protection against intense light sources used on humans and animals for
cosmetic and medical applications - Part 1: Specification for products (ISO 12609-
1:2021)
Augen- und Gesichtsschutz gegen intensive Lichtquellen, die für kosmetische und
medizinische Anwendungen an Menschen und Tieren eingesetzt werden - Teil 1:
Produktanforderungen (ISO 12609-1:2021)
Équipements ophtalmiques de protection contre les sources lumineuses intenses
utilisées sur les animaux et les humains pour des applications médicales et cosmétiques
- Partie 1: Spécifications des produits (ISO 12609-1:2021)
Ta slovenski standard je istoveten z: EN ISO 12609-1:2025
ICS:
13.340.20 Varovalna oprema za glavo Head protective equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 12609-1
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2025
EUROPÄISCHE NORM
ICS 13.340.20
English Version
Eye and face protection against intense light sources used
on humans and animals for cosmetic and medical
applications - Part 1: Specification for products (ISO
12609-1:2021)
Équipements ophtalmiques de protection contre les Augen- und Gesichtsschutz gegen intensive
sources lumineuses intenses utilisées sur les animaux Lichtquellen, die für kosmetische und medizinische
et les humains pour des applications médicales et Anwendungen an Menschen und Tieren eingesetzt
cosmétiques - Partie 1: Spécifications des produits (ISO werden - Teil 1: Produktanforderungen (ISO 12609-
12609-1:2021) 1:2021)
This European Standard was approved by CEN on 17 October 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12609-1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Regulation 2016/425 aimed to be covered . 4

European foreword
This document (EN ISO 12609-1:2025) has been prepared by Technical Committee ISO/TC 94
"Personal safety - Personal protective equipment" in collaboration with Technical Committee CEN/TC
85 “Eye protective equipment” the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2025, and conflicting national standards
shall be withdrawn at the latest by December 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 12609-1:2021 has been approved by CEN as EN ISO 12609-1:2025 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Regulation 2016/425 aimed to be covered
This European Standard has been prepared under a Commission’s standardization request
“M/571/C(2020) 7924 final” to provide one voluntary means of conforming to requirements of
Regulation 2016/425.
Once this standard is cited in the Official Journal of the European Union under that Regulation
2016/425 compliance with the normative clauses of this standard given in Table ZA.1 confers, within
the limits of the scope of this standard, a presumption of conformity with the corresponding essential
requirements of that Regulation 2016/425 and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Annex II of Regulation
2016/425
Essential Requirements of Clause(s)/sub-clause(s) Remarks/Notes
Regulation of this EN
1.1.1 Ergonomics 5.3
1.1.2.1 Optimum level of 6.1; 6.2; 6.3; 8.2;8.3; 8.4
protection
1.2.1 Absence of risks and other Clause 7; 9.3; 9.5
'inherent' nuisance factors
1.2.1.1 Suitable constituent 5.2
materials
1.2.1.2 Satisfactory surface 5.3
condition of all PPE parts in
contact with the user.
1.3.1 Adaptation of PPE to user 5.3
morphology
1.3.2 Lightness and design 9.6 ; 9.7 ; 9.9
strength
1.4 Manufacturer's instructions Clause 10 ; Clause 11
and information
2.1 PPE incorporating 5.3
adjustment systems
2.3 PPE for the face, eyes and 9.4 ; 9.5
respiratory system
2.9 PPE incorporating 5.3
components which can be
adjusted or removed by the use
2.12 PPE bearing one or more Clause 10 Partially covered : The way to
verify that marking remains
identification markings or
legible throughout the
indicators directly or indirectly
foreseeable useful life of the PPE
relating to health and safety
is not covered by Clause 10.
3.1.1 Impact caused by falling or 9.9 Partially covered : Protection
ejected objects and collision of from the risk caused by collision
parts of the body with obstacle of parts of the body with
obstacles is not covered.
3.9.1Non-ionising radiation 6.1 ; 6.2; 6.3; 6.4; 8.1 ; 8.2; 8.3;
8.4; 9.7; Clause10; Clause 11
Table ZA.2 — Normative references from Clause 2 of this document and their corresponding
European publications
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard Edition
Standard Edition
ISO 4007 ISO 4007:2018 Personal protective EN ISO 4007:2018
equipment — Eye and face
protection — Vocabulary
ISO 18526- ISO 18526-1:2020 Eye and face protection — EN ISO 18526-1:2020
1:2020 Test methods — Part 1:
Geometrical optical
properties
ISO 18526- ISO 18526-2:2020 Eye and face protection — EN ISO 18526-2:2020
2:2020 Test methods — Part 2:
Physical optical properties
ISO 18526- ISO 18526-3:2020 Eye and face protection — EN ISO 18526-3:2020
3:2020 Test methods — Part 3:
Physical and mechanical
properties
ISO 18526- ISO 18526-4:2020 Eye and face protection — EN ISO 18526-4:2020
4:2020 Test methods — Part 4:
Headforms
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
INTERNATIONAL ISO
STANDARD 12609-1
Second edition
2021-10
Eye and face protection against
intense light sources used on humans
and animals for cosmetic and medical
applications —
Part 1:
Specification for products
Équipements ophtalmiques de protection contre les sources
lumineuses intenses utilisées sur les animaux et les humains pour des
applications médicales et cosmétiques —
Partie 1: Spécifications des produits
Reference number
ISO 12609-1:2021(E)
ISO 12609-1:2021(E)
© ISO 2021
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 on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 12609-1:2021(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classes of ILS eye protectors .2
5 General requirements for ILS eye protectors . 2
5.1 Ambient temperatures . 2
5.2 Physiological compatibility . 2
5.3 Construction and adjustment . 3
5.4 Cleaning and/or disinfection . 3
5.5 Headform(s) . 3
5.6 Mandatory and optional requirements . 3
6 Transmittance . 3
6.1 General . 3
6.2 Luminous and spectral transmittance for F-scale numbers . 4
6.3 Luminous and spectral transmittance for B-scale numbers . 4
6.4 Uniformity of luminous transmittance and transmittance matching . 5
7 Colour neutrality (optional requirement) . 5
8 ILS eye protectors with autodarkening filters . 5
8.1 General . 5
8.2 Transmittance . 6
8.3 Angular dependence of luminous transmittance . 6
8.4 Switching time . 6
9 Construction of ILS eye protectors . 6
9.1 Area to be protected from ILS radiation . 6
9.2 Frames and lateral protection . 8
9.3 Material and surface quality . 8
9.4 Field of view . 8
9.5 Optical properties . 8
9.5.1 Spherical and cylindrical power . 8
9.5.2 Spatial deviation . 9
9.5.3 Prismatic power of unmounted plano filters covering one eye . 9
9.5.4 Prism imbalance for mounted filters and one-piece protectors . 9
9.5.5 Narrow angle scatter . 9
9.6 Resistance to ignition . 9
9.7 Resistance to UV radiation . 9
9.8 Resistance to thermal exposure . 10
9.9 Basic impact level of complete ILS eye protectors . 10
9.9.1 Complete protector . 10
9.9.2 Failure criteria. 10
9.9.3 ILS eye protectors with prescription inserts to carry corrective lenses . 11
10 Marking . .11
10.1 General . 11
10.2 Mandatory markings . 11
11 Information to be supplied by the manufacturer .12
Bibliography .13
iii
ISO 12609-1:2021(E)
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 collaboration with the European Committee
for Standardization (CEN) Technical Committee CEN/TC 85, Eye protective equipment, in accordance
with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 12609-1:2013) which has been technically
revised.
The main changes compared to the previous edition are as follows:
— Alignment to ISO 16321 series and ISO 18526 series.
A list of all parts in the ISO 12609 series can be found on the ISO website.
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
INTERNATIONAL STANDARD ISO 12609-1:2021(E)
Eye and face protection against intense light sources
used on humans and animals for cosmetic and medical
applications —
Part 1:
Specification for products
1 Scope
This document specifies general requirements for operators' eye protectors for intense light source
(ILS) equipment used on humans and animals for cosmetic and medical applications against excessive
exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser
radiation.
This document is applicable to devices intended for patient protection during ILS procedures, except
for treatment in the periorbital area. For guidance on patient eye protection during ILS procedures, see
ISO/TR 22463.
For guidance on the use and selection of ILS eye protectors, see ISO 12609-2.
This document does not apply to:
— laser protectors, for which ISO 19818-1 applies;
— protectors for medically prescribed applications (not occupational), e.g. eye protection for severe
dry eye, tints prescribed for medical conditions;
— protectors specifically intended for protection against only solar radiation and used in non-
occupational environments for which the ISO 12312 (all parts) applies;
— protectors used with tanning equipment;
— protectors intended to protect against ionizing radiation, e.g. X-rays, for which IEC 61331-3 applies.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
ISO 4007, Personal protective equipment — Eye and face protection — Vocabulary
ISO 18526-1:2020, Eye and face protection — Test methods — Part 1: Geometrical optical properties
ISO 18526-2:2020, Eye and face protection — Test methods — Part 2: Physical optical properties
ISO 18526-3:2020, Eye and face protection — Test methods — Part 3: Physical and mechanical properties
ISO 18526-4, Eye and face protection — Test methods — Part 4: Headforms
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4007 and the following apply.
ISO 12609-1:2021(E)
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
intense light source
ILS
device incorporating one or more non-laser, pulsed or continuous, sources of optical radiation in the
wavelength range 250 nm to 3 000 nm and intended to cause biological effects in humans and animals
3.2
opaque patient eye protector
protector made from a medium with spectral transmittance no more than 0,01 % in the waveband
250 nm to 3 000 nm
Note 1 to entry: This can be made of metal or intensely pigmented material.
4 Classes of ILS eye protectors
There are three classes of ILS eye protector
a) F-scale eye protector where the scale number is determined by its luminous transmittance for
CIE standard illuminant D65,
b) B-scale protector where the scale number is determined by its blue-light transmittance, and
c) Opaque eye protectors, for patient use only.
5 General requirements for ILS eye protectors
5.1 Ambient temperatures
ILS eye protectors described in this document are intended for use at normal ambient temperatures,
(23 ± 5) °C.
5.2 Physiological compatibility
ILS eye protectors shall be designed and manufactured in such a way that, when used under the
conditions and for the purposes intended, they will not compromise the health or safety of the wearer.
The risks posed by substances leaking or evaporating from the ILS eye protector that can come into
prolonged contact with the wearer shall be reduced by the manufacturer to within the limits of any
applicable regulatory requirement.
Special attention shall be given to substances that are allergenic, carcinogenic, mutagenic or toxic to
reproduction.
NOTE 1 Excessive pressure due to a poor fit on the head, chemical irritation and allergy are known to produce
reactions. Rare or idiosyncratic reactions to any material are known to occur and the individual wearer is well
advised to avoid those types of frame materials.
Substances recommended for cleaning, maintenance or disinfection shall be known to be unlikely to
have any adverse effect upon the wearer when applied in accordance with the instructions given in the
information to be supplied by the manufacturer.
Manufacturers/suppliers shall perform an appropriate risk analysis on potentially harmful substances
contained in the ILS eye protector such that, when the ILS eye protector is used under the intended
conditions and for the purposes intended, the health and safety of the wearer shall not be compr
...