kSIST FprEN ISO 12609-1:2020
(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 12609-1:2020)
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 12609-1:2020)
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 3000 nm, with the exception of laser radiation.
This document is applicable to devices intended for patient protection during ILS procedures except for treatment in periorbital area. For the selection and use of suitable patient eyewear during ILS procedure see ISO/DTR 22463.
This document does not apply to:
- laser protectors, for which ISO 19818 applies;
- protectors for medically prescribed applications (not occupational); e.g. eye protection for severe dry eye, tints prescribed for medical conditions;
- sunglasses for general use for which ISO 12312-1 applies;
- protectors used for tanning equipment;
- protectors intended for direct observation of the sun, such as for solar-eclipse viewing for which ISO 12312-2 applies;
- protectors intended to protect against ionizing radiation 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/DIS 12609-1:2019)
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.
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)
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.
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oSIST prEN ISO 12609-1:2019
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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
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 12609-1:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019
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oSIST prEN ISO 12609-1:2019
ISO/DIS 12609-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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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
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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.
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
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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 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 periorbital area. For the guidance on patient eye protection during ILS procedures, see
ISO/TR 22463.
Guidance on use and selection of ILS eye protectors – see ISO 12609-2.
This document does not apply to:
— laser protectors, for which ISO 19818 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 series 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/FDIS 16321-1, — Eye and face protection for occupational use — Part 1: General requirements
ISO/FDIS 18526-1, — Eye and face protection —Test methods — Part 1: Geometrical optical properties
ISO/FDIS 18526-2, — Eye and face protection — Test methods — Part 2: Physical optical properties
ISO/FDIS 18526-3, — Eye and face protection — Test methods — Part 3: Physical and mechanical
properties
ISO/FDIS 18526-4, — Eye and face protection — Test methods — Part 4: Headforms
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4007 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at http: //www .iso .org/obp
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
4 General requirements for ILS eye protectors
4.1 Ambient temperatures
ILS eye protectors described in this document are intended for use at normal ambient temperatures,
(23 ± 5) °C.
4.2 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 that, when the ILS eye protector is used under the conditions and for
the purposes intended, the health (and safety) of the wearer shall not be compromised.
The following are examples of documents that represent the appropriate information:
a) specifications of the material(s);
b) safety data sheets relating to the materials;
c) information relating to the suitability of the materials for use with food, in medical devices, or
other relevant applications;
d) information relating to toxicological, allergenic, carcinogenic, toxic to reproduction, or mutagenic
properties of the materials.
NOTE 2 Specific national regulations with regard to restriction of certain chemical substances need to be
observed, for example release of nickel.
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4.3 Construction and adjustment
Areas of the ILS eye protector that may, during intended use, come into contact with the wearer shall
be free from projections, sharp edges or other features likely to cause discomfort or injury during use.
Any part of the ILS eye protector that can be adjusted, or removed by the wearer for the purpose of
replacement (in accordance with the instructions given in the information to be supplied by the
manufacturer), shall facilitate adjustment, removal and attachment without the use of tools. Critical
parts, such as the filters, shall not be capable of being removed by the wearer.
Any adjustment system incorporated in the ILS eye protector shall maintain the intended fit for the
foreseeable conditions of use.
The test shall be carried out by physical inspection according to ISO 18526-3: —, 6.1.
4.4 Cleaning and/or disinfection
The ILS eye protectors shall be cleaned only once according to the cleaning and/or disinfection
procedures in the information to be supplied by the manufacturer before being subjected to testing.
4.5 Headform(s)
Unless the manufacturer specifies the headform(s) according to ISO 18526-4 that is/are compatible with
the ILS eye protector, the test methods where (a) headform(s) is/are required shall use the headform
1-M according to ISO 18526-4 as the default.
4.6 Mandatory and optional requirements
In this document both optional and mandatory requirements are described. Depending on the intended
use and/or the manufacturer's claimed specification, some requirements marked as optional become
mandatory.
5 Transmittance
5.1 General
The spectral transmittance τ(λ) of the ILS protection filter at wavelengths between 250 nm and
3 000 nm shall be determined at normal incidence according to ISO 18526-2:-, Clause 6. The luminous
transmittance τ shall be calculated according to ISO 18526-2:-, 7.1 and the blue-light transmittance
v D65
τ shall be calculated according to ISO 18526-2:-, 9.2.1. ILS protection filters shall fulfil the transmittance
B
requirements of either the luminous transmittance τ based scale number designation (F-scale
v D65
numbers) according to 5.2 or the blue-light transmittance τ based scale number designation (B-scale
B
numbers) according to 5.3.
Filters with angularly dependent transmittance shall be measured at angles of incidence between 0°
and at least 30° from the normal and tested according ISO 18526-2:- 17.8. ILS protection filters shall
fulfil the transmittance requirements for the full angular range (-30° to +30°) of either the luminous
transmittance τ based scale number designation (F-scale numbers) according to 5.2 or the blue-light
D65
transmittance τ based scale number designation (B-scale numbers) according to 5.3.
B
NOTE The spectral weighting functions S(λ) and B(λ) are given in ISO 4007:2018 Table A.1.
5.2 Luminous and spectral transmittance for F-scale numbers
The F-scale number of ILS eye protector shall be determined in accordance with Table 1 when tested
according to ISO 18526-2: — Clauses 6, 7 and 10.1.
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Table 1 — Transmittance requirements for ILS protection filters; code letter F
Scale num- Spectral transmittance Luminous Near IR transmit-
ber transmittance tance
τ(λ)
τ τ
v D65 NIR
250 nm ≤ λ ≤ 315 nm < λ ≤ 380 nm < λ ≤ Maximum Minimum 780 nm ≤ λ ≤
380 nm 450 nm % % 3 000 nm
315 nm
Maximum Maximum Maximum
Maximum
% %
% %
F1 100 43,2
F2 43,2 17,8
F3 17,8 8,5
0,1 0,4 τ 50
v D65
F4 8,5 3,2
F5 3,2 1,2
F6 1,2 0,44
5.3 Luminous and spectral transmittance for B-scale numbers
In many types of ILS equipment, the blue spectral component of light poses the greatest risk.
The B-scale number of ILS eye protector shall be determined in accordance with Table 2 when tested
according to ISO 18526-2:— Clauses 6, 7 and 10.1.
Table 2 — Transmittance requirements for ILS protection filters, code letter B
Blue-light Near IR transmit-
Spectral transmittance
transmittance tance
τ(λ)
τ
τ
B NIR
Scale num-
250 nm ≤ λ ≤ 315 nm < λ ≤ 380 nm < λ ≤
780 nm ≤ λ ≤
ber
380 nm 450 nm
3 000 nm
315 nm Maximum Minimum
Maximum Maximum % %
Maximum
Maximum
%
%
% %
B1 N/A N/A 43,2
B2 43,2 43,2 17,8
B3 17,8 17,8 8,5
0,1 0,4 50
B4 8,5 8,5 3,2
B5 3,2 3,2 1,2
B6 N/A 1,2 N/A
5.4 Uniformity of luminous transmittance and transmittance matching
ILS protection filters shall fulfil the following requirements for uniformity of transmittance:
a) the relative variations of the luminous transmittance around the reference point(s) ∆F and ∆F
R L
shall be measured according to ISO 18526-2:—, 7.4, as applicable. ∆F and ∆F (as appropriate)
R L
shall not exceed ±10 %.
b) the relative difference of the luminous transmittance ∆P between the right and left eye reference
points shall be measured according to ISO 18526-2:—, 7.5. ∆P shall not exceed ±15 %.
Changes of luminous transmittance that are caused by thickness variations due to the design of the
filter are permitted. For verification, the procedure according to the test method in ISO 18526-2:—,
7.4.1.4 shall be used.
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This requirement can be omitted for opaque patient eye protectors.
6 Colour neutrality (Optional requirement)
If colour neutrality is claimed, the spectral transmittance between 450 nm and 650 nm shall be uniform,
defined as being within ±20 % of the mean transmittance value in this range.
The colour neutrality shall be tested according to ISO 18526-2:—, Clauses 6.
7 ILS eye protectors with autodarkening filters
7.1 General
ILS eye protectors with autodarkening (electro-optical) filters switch from a light state (high
transmittance) to a dark state (low transmittance) during the ILS procedures. Autodarkening eye
protectors protect against the excessive exposure to optical radiation in the spectral range of 250 nm to
3000 nm. ILS eye protectors with autodarkening filters combine passive UV and IR filters that protect
against these respective hazards with an autodarkening filter technology that automatically attenuates
the excessive radiation in the visible spectral range to safe and non-glaring levels.
NOTE In the light state, the protector enables the operator to recognize the required operational details
during the treatment. As soon as reflected bright light, mainly off the patient’s skin, or when the ILS source is
pointed accidentally towards the eyes of the operator, the autodarkening filter switches to the dark state. ILS eye
protectors with autodarkening filters are not intended for patient use.
7.2 Transmittance
ILS eye protectors with autodarkening filters shall provide the required levels of spectral transmittance
(250 nm to 450 nm) and near IR transmittance specified in Tables 1 and 2 in their light and dark states.
The luminous transmittance or the blue-light transmittance shall be within the transmittance ranges
for the shade numbers/categories claimed by the manufacturer for both light and dark states.
If the power supply is disconnected or malfunctions, ILS eye protectors with autodarkening filters
powered by mains, batteries or photoelectric cells shall reduce the luminous transmittance (380 nm
to 780 nm) to a maximum of 30 % and the spectral transmittance (250 nm to 450 nm) and the near IR
transmittance requirements of the scale number F2 or B2 or darker specified in Table 1 or 2 shall also
be fulfilled.
7.3 Angular dependence of luminous transmittance
Autodarkening filters with angularly dependent transmittance shall be measured at angles of incidence
between 0° and at least 30° from the normal.
When measured according to ISO 18526-2:—, 17.8, at a temperature of (23 ± 5) °C, the maximum values
of V and V of F-scale number and B-scale number autodarkening filters measured in white light (CIE
15 30
standard illuminant A) shall not exceed the values given in Table 3. The requirement shall apply to the
light and to the dark states.
Table 3 — Angular dependence of luminous transmittance of autodarkening filters
Maximum values of V Maximum values of V
15 30
7,20 (corresponding to 2 scale numbers) 51,75 (corresponding to 4 scale numbers)
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7.4 Switching time
The time taken by an ILS eye protector with autodarkening filters to reach its maximum specified scale
number (“dark state”) in response to exposure to incident optical radiation shall not exceed 1 ms when
determined according to ISO 18526-2:—, 17.11.
8 Construction of ILS eye protectors
8.1 Area to be protected from ILS radiation
Figure 1 and Table 4 describe the minimum areas to be protected against optical radiation from the ILS.
Ronald comments – the original seems clumsy – why mention "individual"? The equivalent sentence in
ISO 16321-1, 7, is much simpler.
The dimensions of the headform(s) are defined in ISO 18526-4.
When tested according to ISO 18526-3:—, 6.3, the ILS protector shall cover two ellipses projected on
to the headform defined in Table 4 and Figure 1. These ellipses have a horizontal dimension of b and a
vertical dimension c, the centres of which are separated by dimension a and are symmetrically placed
on either side of the centre of the bridge of the headform nose, i.e. the vertical axis of symmetry midway
between the corneal apices.
When tested from each side according to ISO 18526-3:—, 6.4, the ILS protector shall cover the area
projected on to the headform defined in Table 4 and Figure 1. This area is bounded by a semicircle of
r
...
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