FprEN ISO 12609-1
(Main)Eye and face protection against intense light sources used on humans and animals for cosmetic and medical applications - Part 1: Specification for products (ISO/FDIS 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/FDIS 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/FDIS 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/FDIS 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/DIS 12609-1:2019)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 12609-1:2019
01-december-2019
Varovanje oči in obraza pred intenzivnimi viri svetlobe pri ljudeh in živalih za
uporabo v kozmetiki in medicini - 1. del: Specifikacija za proizvod (ISO/DIS 12609-
1:2019)
Eye and face protection against intense light sources used on humans and animals for
cosmetic and medical applications - Part 1: Specification for products (ISO/DIS 12609-
1:2019)
Augen- und Gesichtsschutz gegen intensive Lichtquellen, die für kosmetische und
medizinische Anwendungen an Menschen und Tieren eingesetzt werden - Teil 1:
Produktanforderungen (ISO/DIS 12609-1:2019)
Protection des yeux et du visage contre les sources lumineuses intenses utilisées sur les
animaux et les humains pour des applications médicales et cosmétiques - Partie 1:
Spécifications des produits (ISO/DIS 12609-1:2019)
Ta slovenski standard je istoveten z: prEN ISO 12609-1
ICS:
13.340.20 Varovalna oprema za glavo Head protective equipment
oSIST prEN ISO 12609-1:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
oSIST prEN ISO 12609-1:2019
oSIST prEN ISO 12609-1:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 12609-1
ISO/TC 94/SC 6 Secretariat: BSI
Voting begins on: Voting terminates on:
2019-09-25 2019-12-18
Eye and face protection against intense light sources
used on humans and animals for cosmetic and medical
applications —
Part 1:
Specification for products
Protection des yeux et du visage contre les sources lumineuses intenses utilisées sur les animaux et les
humains pour des applications médicales et cosmétiques —
Partie 1: Spécifications des produits
ICS: 13.340.20
THIS DOCUMENT IS A DRAFT CIRCULATED
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ISO/DIS 12609-1:2019(E)
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NOTIFICATION OF ANY RELEVANT PATENT
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©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
oSIST prEN ISO 12609-1:2019
ISO/DIS 12609-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2019 – All rights reserved
oSIST prEN ISO 12609-1:2019
ISO/DIS 12609-1:2019(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for ILS eye protectors . 2
4.1 Ambient temperatures . 2
4.2 Physiological compatibility . 2
4.3 Construction and adjustment . 3
4.4 Cleaning and/or disinfection . 3
4.5 Headform(s) . 3
4.6 Mandatory and optional requirements . 3
5 Transmittance . 3
5.1 General . 3
5.2 Luminous and spectral transmittance for F-scale numbers . 3
5.3 Luminous and spectral transmittance for B-scale numbers. 4
5.4 Uniformity of luminous transmittance and transmittance matching . 4
6 Colour neutrality (Optional requirement) . 5
7 ILS eye protectors with autodarkening filters . 5
7.1 General . 5
7.2 Transmittance . 5
7.3 Angular dependence of luminous transmittance . 5
7.4 Switching time . 6
8 Construction of ILS eye protectors . 6
8.1 Area to be protected from ILS radiation . 6
8.2 Frames and lateral protection . 7
8.3 Material and surface quality . 7
8.4 Field of view . 7
8.5 Optical properties . 8
8.5.1 Spherical and cylindrical power . 8
8.5.2 Spatial deviation . 8
8.5.3 Prismatic power of unmounted plano filters covering one eye . 8
8.5.4 Prism imbalance for mounted filters and one-piece protectors . 8
8.5.5 Narrow angle scatter . 9
8.6 Resistance to ignition . 9
8.7 Resistance to UV radiation . 9
8.8 Resistance to thermal exposure . 9
8.9 Basic Impact Level of complete ILS eye protectors . 9
8.9.1 Complete protector . 9
8.9.2 Failure criteria .10
8.9.3 ILS eye protectors with inserts to carry prescription lenses . .10
9 Marking .10
9.1 General .10
9.2 Mandatory markings . .11
10 Information to be supplied by the manufacturer .11
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Regulation 2016/425 aimed to be covered .13
Bibliography .15
oSIST prEN ISO 12609-1:2019
ISO/DIS 12609-1:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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electrotechnical standardization.
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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
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on the ISO list of patent declarations received (see www .iso .org/patents).
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.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.
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 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 © ISO 2019 – All rights reserved
oSIST prEN ISO 12609-1:2019
DRAFT INTERNATIONAL STANDARD ISO/DIS 12609-1:2019(E)
Eye and face protection against intense light sources
used on
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