SIST EN ISO 12609-1:2025

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)

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.

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)

Dieses Dokument legt grundlegende Anforderungen an Augenschutzgeräte für intensive Lichtquellen (ILS, en: intense light source) fest, die von Bedienern für medizinische und kosmetische Anwendungen an Menschen und Tieren eingesetzt werden und dabei einer übermäßigen Belastung durch optische Bestrahlung im Spektralbereich zwischen 250 nm und 3 000 nm ausgesetzt sind, mit Ausnahme von Laserstrahlung.
Dieses Dokument ist für Geräte anwendbar, die für den Patientenschutz bei ILS-Anwendungen vorgesehen sind, außer für Behandlungen im periorbitalen Bereich. Siehe ISO/TR 22463, als Leitfaden für den geeigneten Patientenaugenschutz während ILS-Anwendungen.
Siehe ISO 12609-2 bezüglich der Auswahl und der Anwendung von ILS-Augenschutzgeräten.
Dieses Dokument gilt nicht für:
- Laserschutzgeräte, für die ISO 19818-1 gilt;
- Schutzgeräte für medizinisch verschriebene Anwendungen (nicht beruflich); z. B. Augenschutz für sehr trockene Augen, medizinisch verschriebene Tönungen;
- Schutzgeräte, die nur zum Sonnenschutz und in nicht beruflichen Umgebungen verwendet werden, für die ISO 12312 (alle Teile) gilt;
- Schutzgeräte, die für Bräunungen verwendet werden;
- Schutzgeräte, die zum Schutz gegen ionisierende Strahlung, z. B. Röntgenstrahlung, für die IEC 61331-3 gilt, verwendet werden.

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)

Le présent document spécifie les exigences générales applicables aux protecteurs de l'œil des opérateurs dans des équipements à source lumineuse intense (SLI) utilisés sur les humains et les animaux pour des applications cosmétiques et médicales, contre une exposition excessive à des rayonnements optiques d'une plage spectrale comprise entre 250 nm et 3 000 nm, à l'exception des rayonnements laser.
Le présent document s'applique aux dispositifs destinés à la protection des patients au cours de modes opératoires impliquant des SLI, à l'exception des traitements dans la région périorbitale. Pour des recommandations relatives à la protection de l'œil des patients au cours de modes opératoires impliquant des SLI, voir l'ISO/TR 22463.
Pour des recommandations relatives à l'utilisation et au choix de protecteurs de l'œil contre les SLI, voir l'ISO 12609-2.
Le présent document ne s'applique pas:
—    aux protecteurs contre les lasers couverts par l'ISO 19818-1;
—    aux protecteurs destinés à des applications couvertes par une ordonnance médicale (à caractère non professionnel), par exemple protection de l'œil en cas de sécheresse oculaire sévère, verres teintés prescrits pour raisons médicales;
—    aux protecteurs spécifiquement conçus pour assurer une protection uniquement contre le rayonnement solaire et qui sont utilisés dans des environnements non professionnels, couverts par l'ISO 12312 (toutes les parties);
—    aux protecteurs utilisés avec des équipements de bronzage;
—    aux protecteurs conçus pour assurer une protection contre les rayonnements ionisants, par exemple les rayons X, lesquels sont couverts par l'IEC 61331-3.

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)

General Information

• Status: Published
• Public Enquiry End Date: 14-Dec-2019
• Publication Date: 20-Aug-2025
• ICS: 13.340.20 - Head protective equipment
• Technical Committee: OVP - Personal protecting equipment
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 14-Jul-2025
• Due Date: 18-Sep-2025
• Completion Date: 21-Aug-2025
• Directive: 2016/425 - Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
• Mandate: M/571 - COMMISSION IMPLEMENTING DECISION of 19.11.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards personal protective equipment in support of Regulation (EU) 2016/425 of the European Parliament and of the Council
• Mandate: M/571 AMD 1 - Personal Protective Equipement
• Ref Project: EN ISO 12609-1:2025 - 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)

Standards Content (Sample)

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: [phone]
Email: [e-mail]
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 .
...