ISO 12609-1:2013

Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications — Part 1: Specification for products

ISO 12609-1:2013 specifies performance and labelling of eye protectors used for 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. ISO 12609-1:2013 provides a specification for an eye protector expected to cope with the majority of applications. A more rigorous procedure for determining appropriate eye protection against spectral outputs from ILS equipment is described in the annexes.

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

General Information

• Status: Withdrawn
• Publication Date: 22-Jul-2013
• Withdrawal Date: 22-Jul-2013
• 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/WG 4 - Occupational eye and face protection
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 15-Oct-2021

Relations

• Revised: 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
• Effective Date: 10-Dec-2016

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 12609-1
First edition
2013-07-15
Eyewear for 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 12609-1:2013(E)
©
ISO 2013

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ISO 12609-1:2013(E)

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© ISO 2013
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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Published in Switzerland
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ISO 12609-1:2013(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Transmittance . 2
4.1 General . 2
4.2 F-classification . 2
4.3 B-classification . 3
4.4 Luminous transmittance . 4
5 Colour recognition . 4
5.1 General . 4
5.2 Colour of the protective filters. 5
6 Auto darkening filters . 5
7 Construction of eye protectors . 6
7.1 General . 6
7.2 Frames and side shields . 6
7.3 Materials . 6
7.4 Adjustment . 6
7.5 Removal of filters . 7
7.6 Material and surface quality . 7
7.7 Field of view . 7
7.8 Optical properties . 7
7.9 Resistance to ignition . 8
7.10 Resistance to ageing by UV radiation . 8
7.11 Resistance to thermal ageing . 8
8 Labelling . 8
9 Information to be supplied by the manufacturer . 9
Annex A (informative) Filter protection factor (FPF) .10
Annex B (informative) Calculation of FPF for protective eyewear — Example 1 .12
Annex C (informative) Calculation of FPF for protective eyewear — Example 2 .15
Annex D (informative) Spectral hazard weighting functions .18
Annex E (normative) Test method for narrow angle scattering (diffusion of light) .21
Annex F (normative) Test for resistance to ignition .27
Annex G (normative) Test for resistance to ultraviolet radiation .28
Annex H (normative) Test for stability at elevated temperature .29
Bibliography .30
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ISO 12609-1:2013(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. 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. 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.
The committee responsible for this document is ISO/TC 94, Personal safety — Protective clothing and
equipment, Subcommittee SC 6, Eye and face protection.
ISO 12609 consists of the following parts, under the general title Eyewear for protection against intense
light sources used on humans and animals for cosmetic and medical applications:
— Part 1: Specification for products
— Part 2: Guidance for use
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INTERNATIONAL STANDARD ISO 12609-1:2013(E)
Eyewear for protection against intense light sources
used on humans and animals for cosmetic and medical
applications —
Part 1:
Specification for products
1 Scope
This part of ISO 12609 specifies performance and labelling of eye protectors used for 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 part of ISO 12609 provides a specification for an eye protector expected to cope with the majority
of applications. A more rigorous procedure for determining appropriate eye protection against spectral
outputs from ILS equipment is described in the annexes.
This part of ISO 12609 is not applicable to eye protectors for use with tanning equipment, ophthalmic
instruments or other medical/cosmetic devices, the safety issues of which are addressed through other
European and International standards.
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
ISO 12311:2013, Personal protective equipment — Test methods for sunglasses and related equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
blue light hazard
potential for a photochemically induced retinal injury resulting from optical radiation exposure in the
wavelength range 300 nm to 700 nm
3.2
filter protection factor
FPF
factor by which the filter attenuates the weighted ocular exposure
Note 1 to entry: Mathematical expressions for FPF are given in Annex A and example calculations in Annex B
and Annex C.
3.3
infra-red lens hazard
potential for a thermal injury to cornea and lens of the eye resulting from optical radiation exposure in
the wavelength range 780 nm to 3 000 nm
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ISO 12609-1:2013(E)

3.4
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 and animals
Note 1 to entry: It can operate in a continuous or pulsed regime.
3.5
retinal thermal hazard
potential for a thermal retinal injury resulting from optical radiation exposure in the wavelength range
380 nm to 1 400 nm
3.6
ultraviolet hazard
potential for skin and ocular acute and chronic adverse effects resulting from optical radiation exposure
in the wavelength range 250 nm to 400 nm
4 Transmittance
4.1 General
The spectral transmittance of the ILS eye protector at the wavelengths between 250 nm and 3 000 nm
shall be specified.
The spectral transmittance τ(λ) of the eye protector material shall be determined for normal incidence.
The wavelength shall be determined at not more than 10 nm intervals with the central wavelength
known to within ± 2 nm from 250 to 800 nm and within ± 4 nm above 800 nm. The bandwidth of the
detector (full width half maximum) shall not exceed 5 nm.
Filters with angular dependent transmittance shall be measured at angles of incidence between at
least 0° and 30°.
In addition, ILS eyewear may be designated F- or B- scale numbers according to 4.2 and/or 4.3.
4.2 F-classification
ILS eyewear may be designated F-scale number using the F-classification scheme described in Table 1.
NOTE The F-numbers in Table 1 are related to the shade numbers with some relaxation in the infrared region.
Luminous transmittance shall be determined according to 4.4.
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ISO 12609-1:2013(E)

Table 1 — Transmittance requirements for general purpose ILS filters
Maximum mean
Maximum spectral transmittance in the Luminous
transmittance in the
ultraviolet spectral range transmittance
infrared spectral range
Scale num- τ(λ) τ
v
τ
NIR
ber
250 nm to >315 nm to
>380 nm to Maximum Minimum 780 nm to 3 000 nm
315 nm 380 nm
450 nm % % %
% %
F-1 0,1 0,4 τ 100 43,2 50
v
F-2 0,1 0,4 τ 43,2 17,8 50
v
F-3 0,1 0,4 τ 17,8 8,5 50
v
F-4 0,1 0,4 τ 8,5 3,2 50
v
F-5 0,1 0,4 τ 3,2 1,2 50
v
F-6 0,1 0,4 τ 1,2 0,44 50
v
4.3 B-classification
In many types of ILS it is the blue component of light that poses the greatest risk. To take account of this,
a ‘blue light’ B-classification scheme described in Table 2 may be used.
Blue light transmittance τ should be determined as:
B
λ=550
EB()λλ()τλ()dλ
∫
λ=380
τ =×100%
B
λ=550
EB()λλ()dλ
∫
λ=380
where
−2 −1
E(λ) is the spectral irradiance of the CIE Standard Illuminant D65, in W m nm ;
B(λ) is blue light hazard weighting function (see Annex D);
τ(λ) is the spectral transmittance of filter material at wavelength λ;
Δλ is the wavelength interval of the measurements, in nm.
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ISO 12609-1:2013(E)

Table 2 — Transmittance requirements for blue light ILS filters
Maximum mean
Maximum spectral transmittance in the Blue light
transmittance in the
ultraviolet spectral range transmittance
infrared spectral range
τ (λ) τ
UV B
Scale num-
τ (λ)
NIR
ber
250 nm to >315 nm to
>380 nm to Maximum Minimum 780 nm to 3 000 nm
315 nm 380 nm
450 nm % % %
% %
B-1 0,1 0,4 τ 100 43,2 50
B
B-2 0,1 0,4 τ 43,2 17,8 50
B
B-3 0,1 0,4 τ 17,8 8,5 50
B
B-4 0,1 0,4 τ 8,5 3,2 50
B
B-5 0,1 0,4 τ 3,2 1,2 50
B
B-6 0,1 0,4 τ 1,2 0,44 50
B
4.4 Luminous transmittance
The luminous transmittance τ of the protective filters intended for use by the ILS operator shall be
V
determined as:
λ=780
EV()λλ()τλ()dλ
∫
λ=380
τ =
V
λ=780
EV()λλ()dλ
∫
λ=380
where
−2 −1
E(λ) is the spectral irradiance of the CIE Standard Illuminant D65, in W m nm ;
V(λ) is spectral luminous efficiency;
Δλ is the wavelength interval of the measurements, in nm;
τ(λ) is the spectral transmittance of filter material at wavelength λ.
NOTE There are no requirements for the luminous transmittance of the filters of eye protectors intended for
use by ILS equipment patients/clients; these filters may be opaque.
5 Colour recognition
5.1 General
There are no requirements for colour neutrality.
If colour neutrality is claimed, spectral transmittance between 450 nm and 650 nm shall be uniform
within ± 20 % of the mean transmittance value in this range.
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ISO 12609-1:2013(E)

5.2 Colour of the protective filters
The Commission Internationale de L’Eclairage (CIE) colour coordinates (x, y) of the protective filters
intended for use by the ILS operator shall be determined as:
X
x=
XY++Z
and
Y
y=
XY++Z
where
λ=780
XE= τλ() ()λλxd() λ
∫
λ=380
λ=780
YE= τ()λλλ()yd() λ
∫
λ=380
λ=780
ZE= τλ() ()λλzd() λ
∫
λ=380
and
are CIE colour matching functions;
xy,andz
−2 −1
E(λ) is the spectral irradiance of the CIE Standard Illuminant D65, in W m nm ;
Δλ is the wavelength interval of the measurements, in nm;
τ(λ) is the spectral transmittance of filter material at wavelength λ.
NOTE 1 The colour coordinates (x, y) of the protective filters might be optionally presented on a CIE
chromaticity chart.
NOTE 2 There are no requirements for the colour perception of the filters of eye protectors intended for use by
ILS equipment patients/clients; these filters may be opaque.
6 Auto darkening filters
Auto darkening filters shall provide the required levels of IR and UV protection specified in Tables 1
and 2 in light and dark states.
In the case of protective filters that exhibit a change of luminous transmittance in response to an
exposure to incident optical radiation, the time taken by the eye protector to reach 3x the minimum
luminous transmittance (“dark state”) shall be determined.
Auto darkening filters powered by mains, batteries or photoelectric cells shall reduce the luminous
transmittance (380 nm to 780 nm) to maximum of 30 % if the power supply is disconnected or
malfunctions.
The minimum luminous transmittance in the light and dark states of auto darkening filters shall be
specified, for the angles of incidence at least between 0° and 30°.
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ISO 12609-1:2013(E)

7 Construction of eye protectors
7.1 General
Mirror-finish or metalized finishes on filters or frames shall not be used.
NOTE Secondary reflections from frames or filters of protective eyewear, especially from concave surfaces,
might increase the risk of uncontrolled exposure of the users.
7.2 Frames and side shields
Frames and side shields through which exposure to incident optical radiation could occur to the eyes
shall give at least the same protection as the filters and shall be designed to prevent the leakage of
optical radiation around the edges of protective eyewear.
7.3 Materials
When assessed in accordance with visual inspection, for those parts of the eye protector that come into
contact with the skin, materials shall not be used which are known to be likely to cause skin irritation
or any adverse effect on health.
Substances recommended for cleaning, maintenance or disinfection shall have no adverse effect on the
eye protector and shall be known not to be likely to have any adverse effect upon the wearer, when
applied in accordance with the eye protector manufacturer’s instructions.
Information claiming that the product is innocuous shall be examined.
The following are examples of documents that shall be provided for examination:
— materials specifications;
— safety data sheets relating to the materials;
— information relating to the suitability of the materials for use with food, in medical devices, or other
relevant applications;
— information relating to toxicological, allergenic, carcinogenic, toxic to reproduction, or mutagenic
investigations on the materials.
If the eye or face protector incorporates metallic components which are in direct and prolonged contact
with the user during wear, these components shall optionally be tested for nickel release according to
2
ISO/TS 24348. The nickel release shall be less than 0,5 μg/cm /week.
NOTE National regulations may require assessment of nickel release to be mandatory.
When examined by a person with a visual acuity of at least 1,0 (6/6 or 20/20), when viewing without
magnification but wearing the appropriate correction, if any, for near vision, there shall be no sharp
edges, roughness or projection on any parts of the eye protector which are in contact, or potential
contact, with the wearer, when the eye protector is worn, such as is likely to cause injury to the wearer.
7.4 Adjustment
Any part of the eye protector that can be adjusted, or removed by the wearer for the purpose of
replacement (in accordance with the eye protector manufacturer’s instructions), shall be so designed
and manufactured as to facilitate adjustment, removal and attachment without the use of tools.
Any adjustment system incorporated within the eye protector shall be so designed and manufactured as
not to become incorrectly adjusted without the wearer’s knowledge under the foreseeable conditions of use.
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ISO 12609-1:2013(E)

Test by visual inspection, and adjustment/donning in accordance with the manufacturer’s instructions,
followed by a minimum of 5 min of wear while seated. During this wear period, the head shall be moved
side to side and up/down 3 times per minute.
7.5 Removal of filters
The removal of individual filters from the frame shall only be possible with the use of tools.
If the filters consist of several individual filters (hybrid filters), they shall be assembled in such a way
that they cannot be interchanged.
NOTE Hybrid filters should not delaminate after storage, when tested in accordance with Annex G and Annex H.
7.6 Material and surface quality
Except in a marginal area 5 mm wide, filters shall have no material or machining defects within an area
of 30 mm diameter around the reference point that may impair vision, e.g. bubbles, scratches, inclusions,
dull spots, pitting, mould marks, notches, reinforced areas, specks, beads, water specks, pocking, gas
inclusions, splintering, cracks, polishing defects or undulations.
Test according to ISO 12311:2013, 6.2.
7.7 Field of view
Eye protectors intended for use by ILS equipment operators shall have a clear field of view at least ± 40°
with respect to the corneal vertex in the vertical and horizontal directions for each eye.
NOTE There are no requirements for the field of view, material and surface defects of the filters of eye
protectors intended for use by ILS equipment patients/clients; these filters may be opaque.
7.8 Optical properties
7.8.1 Variation in transmittance
The relative variations of the transmittance around the visual centre(s) shall not exceed ± 10 %.
The relative variations of the luminous transmittance around the visual centre(s) shall not exceed ± 10 %.
The relative variations of the luminous transmittance between left and right eye shall not exceed ± 10 %.
7.8.2 Spherical and astigmatic power
The oculars shall be tested at the reference points in the as worn position according to ISO 12311:2013,
8.1 after cleaning according to the manufacturer’s instructions.
The spherical power and astigmatic power shall not exceed the following tolerances.
— Spherical power - Mean value of the optical power values in the two principal meridians [(D + D )/2
1 2
dioptres]: ±0,06.
— Astigmatic power - Absolute difference between the optical power values in the two principal
meridians (|D - D | dioptres): 0,06.
1 2
— Additional requirements for mounted oculars, one-piece and visor types: the maximum difference
between the measured spherical powers of the right and left eye shall be 0,12 dioptres.
7.8.3 Local variations in refractive power
The image of the chart used to assess spherical and astigmatic power at of ISO 12311:2013, 8.3.1, shall
be clear and sharp.
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ISO 12609-1:2013(E)

If during the measurements using the telescope a doubling or other aberration of the image is observed then
the oculars shall be tested at the reference point in the as worn position according to ISO 12311:2013, 8.3.
7.8.4 Prismatic deviation of unmounted oculars
The oculars shall be tested at the reference point in the as worn position according to the test method in
ISO 12311:2013, 8.1 after cleaning according to the manufacturer’s instructions.
The prismatic power shall not exceed 0,12 prism dioptres.
7.8.5 Prismatic power difference for mounted oculars and one-piece protectors
The oculars shall be tested in the as worn position according to ISO 12311:2013, 8.2 after cleaning
according to the manufacturer’s instructions.
Use the diaphragm LB2 with Xb = (32,0±0,2) mm. Alternatively a diaphragm with a different Xb may be
used if specified by the manufacturer.
The prismatic power difference shall not exceed the values in Table 3.
Table 3 — Maximum permitted prismatic power differences for mounted oculars and one
piece protectors
Horizontal Vertical
Base out Base in Prism dioptres
prism dioptres prism dioptres
0,75 0,25 0,25
7.8.6 Narrow angle scattering (diffusion of light)
−2 −1
The value of the reduced luminance factor (diffusion) shall not exceed 1,0 cd·m ·lx when measured
according to Annex E after cleaning according to the manufacturer’s instructions.
7.9 Resistance to ignition
All parts of eye protectors that are exposed when worn shall be tested in accordance with Annex F and
shall not ignite or continue to glow after removal of the heated rod.
7.10 Resistance to ageing by UV radiation
When tested in accordance with Annex G, the relative change of luminous transmittance shall not be
· 2· −1
greater than ± 10 % and the value of the reduced luminous factor shall not exceed 0,5 cd m- lx .
7.11 Resistance to thermal ageing
When tested in accordance with Annex H, eye protectors shall not show apparent deformation.
8 Labelling
Each ILS eye protector shall be clearly and permanently marked to indicate the following:
a) model number;
b) manufacturer’s identification;
c) eyewear classified according to 4.2 and/or 4.3 shall be marked F-# and/or B-#, respectively,
where # = 1 to 6;
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ISO 12609-1:2013(E)

d) PD or PD range, if applicable.
If the information is marked on the filters, they shall not impair vision or the protective effect.
9 Information to be supplied by the manufacturer
Each ILS eye protector shall be supplied with printed user information in the language(s) of the country
in which the eye protector is sold. This information shall include:
a) a clear statement of the model number of the eye protection;
b) a reproduction of the labelling in accordance with Clause 8 and an explanation of its meaning;
c) spectral transmittance in accordance with Clause 4, in graphical or tabular form at 10 nm intervals;
d) an explanation of the F-# and/or B-# marking conforming with 4.2 or 4.3 as appropriate, in tabular
or graphic form at 10 nm intervals;
e) luminous transmittance in accordance with 4.4;
f) the CIE colour coordinates (x, y) of the protective filters in accordance with 5.2, with optional
presentation on a CIE chromaticity chart;
g) PD or PD range, if applicable;
h) for auto darkening filters, the minimum luminous transmittance in the light and dark states;
i) for auto darkening filters powered by electrical mains, batteries or photovoltaic cells, specification
of power settings and power tolerances;
j) instructions for use, care, storage, cleaning and disinfection of the eye protector;
k) instructions for inspection and guidance on when the eye protector should be replaced;
l) the name and address of the manufacturer or supplier of the eye protector.
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ISO 12609-1:2013(E)

Annex A
(informative)

Filter protection factor (FPF)
A.1 Neither optical density nor shade numbers are suitable for characterization of ILS protective
filters as these characteristics do not take into account the difference in the effect of different wavelengths
[10]
on the eye, whereas exposure limit values (ELVs) (taken from Reference ) refer to effective, e.g.
spectrally weighted values.
A.2 FPF is defined as:
λ=700
EB()λλ()dλ
∫
λ=300
FPF = (A.1)
BL
λ=700
EB()λλ()τλ()dλ
∫
λ=300
for blue light hazards;
λ=1400
ER()λλ()dλ
∫
λ=380
FPF = (A.2)
RTh
λ=1400
ER()λλ()τλ()dλ
∫
λ=380
for retinal thermal hazards;
λ=400
ES()λλ()dλ
∫
λ=180
FPF = (A.3)
UV
λ=400
ES()λλ()τλ()dλ
∫
λ=180
for actinic ultraviolet hazards; and
λ=3000
Ed()λλ
∫
λ=780
FPF = (A.4)
IR,lens
λ=3000
Ed()λτ()λλ
∫
λ=780
for infrared lens hazards;
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ISO 12609-1:2013(E)

where
−2 −1
E(λ) is the spectral irradiance of the ILS device, in W m nm ;
B(λ), R(λ) and S(λ) are blue light, retinal thermal and actinic ultraviolet hazard weighting functions,
respectively (see Annex D);
Δλ is the wavelength interval of the measuremen
...