FprEN ISO 16321-4

SLOVENSKI STANDARD
oSIST prEN ISO 16321-4:2023
01-oktober-2023
Zaščita za oči in obraz za poklicno uporabo - 4. del: Dodatne zahteve za zaščito
pred biološkimi nevarnostmi (ISO/DIS 16321-4:2023)
Eye and face protection for occupational use - Part 4: Additional requirements for
protection against biological hazards (ISO/DIS 16321-4:2023)
Augen- und Gesichtsschutz für berufliche Anwendungen - Teil 4:Zusätzliche
Anforderungen zum Schutz vor biologischen Gefahren (ISO/DIS 16321-4:2023)
Protection des yeux et du visage à usage professionnel - Partie 4: Exigences
complémentaires pour la protection contre les risques biologiques (ISO/DIS 16321-
4:2023)
Ta slovenski standard je istoveten z: prEN ISO 16321-4
ICS:
13.340.20 Varovalna oprema za glavo Head protective equipment
oSIST prEN ISO 16321-4:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 16321-4:2023
oSIST prEN ISO 16321-4:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16321-4
ISO/TC 94/SC 6 Secretariat: BSI
Voting begins on: Voting terminates on:
2023-08-01 2023-10-24
Eye and face protection for occupational use —
Part 4:
Additional requirements for protection against biological
hazards
ICS: 13.340.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
ISO/DIS 16321-4:2023(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 2023

oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16321-4
ISO/TC 94/SC 6 Secretariat: BSI
Voting begins on: Voting terminates on:

Eye and face protection for occupational use —
Part 4:
Additional requirements for protection against biological
hazards
ICS: 13.340.20
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 16321-4:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements for protectors . 4
4.1 General . 4
4.2 Ambient temperature . 4
4.3 Replacement of components . 5
4.4 Robustness . 5
4.4.1 Principle . 5
4.4.2 Testing . 5
4.4.3 Failure criteria. 5
4.5 Cleaning . 5
4.6 Product disinfection for re-usable protectors . 6
4.6.1 Principle . 6
4.6.2 UV-C disinfection . 6
4.6.3 Disinfection by other means . 6
4.6.4 Testing . 6
5 Physical optical properties for protectors . 7
5.1 Transmittance . 7
5.1.1 Lenses without deliberate filtering action . 7
5.1.2 Luminous transmittance of lenses without deliberate filtering action . 7
5.1.3 Assessment of colour . 7
5.2 Sunglare filters . 7
5.2.1 General . 7
5.2.2 Luminous and spectral transmittance and scale numbers . 7
5.2.3 Marking of sunglare filters . 8
6 Physical and mechanical requirements for protectors . 8
6.1 Area to be protected . 8
6.1.1 Area to be protected: Level I . 9
6.1.2 Area to be protected: Level II and Level II+ . 10
6.2 Protection against spurt and spray . 11
6.3 Protection from aerosols (optional) . 11
6.3.1 General . 11
6.3.2 Aerosol Protection for Level I Area to be protected . 11
6.3.3 Aerosol protection for Level II or II+ Area to be protected . 11
7 Spurt and spray test .12
7.1 Principle . 12
7.2 Reagents, materials and apparatus .12
7.2.1 Headform .12
7.2.2 Volumetric flask .12
7.2.3 Magnetic stirrer .12
7.2.4 Biofluid simulant .12
7.2.5 Spray and spurt generator .12
7.3 Procedure . 13
7.3.1 Calibration of test apparatus . 13
7.3.2 Checking during use . 14
7.3.3 Cleaning . 14
7.3.4 Test procedure.15
7.4 Test report . 15
iii
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
8 Marking of eye protectors and packaging .15
8.1 General . 15
8.2 Mandatory markings on lenses . 16
8.3 Mandatory markings on frames . 16
9 Information to be supplied by the manufacturer .16
Annex A (informative) Guidance for the selection, use, maintenance and disposal of eye
protection for biological hazards .18
Annex B (informative) Risk matrix for product selection .21
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Regulation 2016/425 aimed to be covered .27
Bibliography .29
iv
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(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.
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.
v
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
Introduction
This Standard has been developed in the context of the COVID 19 pandemic, with significant learnings
relating to infection control procedures accelerated in 2020. An informative Annex is included in
this standard which provides information intended to guide end users and organisations about
the appropriate PPE specifically relating to eye or eye and face protection. The guidance is based
on knowledge of best-practice and may be used to help define and develop procedures and practice,
incorporating the use of products complying with this standard.
The requirements and principles apply independently of the method of manufacture.
vi
oSIST prEN ISO 16321-4:2023
DRAFT INTERNATIONAL STANDARD ISO/DIS 16321-4:2023(E)
Eye and face protection for occupational use —
Part 4:
Additional requirements for protection against biological
hazards
1 Scope
This document specifies minimum requirements for protectors designed to provide protection for
the eyes or eyes and face from biological hazards, such as human or other animal bodily fluids and
microorganisms, including viruses and other particulates, that may deposit onto the face or eyes.
This document specifies requirements for both single-use (disposable) and re-usable (disinfectable)
products or components.
This document applies to all afocal (plano) and prescription lensed protectors and their components.
This document does not apply to:
— protectors intended for protection from specific hazards, e.g., impact from high speed particles,
harmful artificial optical radiation, dusts, molten metals, heat, flame, hot solids, harmful gases,
vapours (refer to ISO 16321 parts 1 to 3);
— protectors specifically for sports (refer to ISO 18527 series);
— protectors for lasers (refer to ISO 19818-1);
— respiratory protection against aerosols (refer to ISO 16900 series);
Note 1 Guidance relating to the specific selection, use and maintenance is provided in Annex A.
Note 2 Where eye and face protection is incorporated in protective equipment, such as a hood, full face
respirators, PAPR hoods and headtops, the relevant requirements of this standard apply to the components
providing eye and face protection.
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 18526-1, Eye and face protection — Test methods — Part 1: Geometrical optical properties
ISO 18526-2, Eye and face protection — Test methods — Part 2: Physical optical properties
ISO 18526-3, Eye and face protection — Test methods — Part 3: Physical mechanical properties
ISO 18526-4, Eye and face protection — Test methods — Part 4: Headforms
ISO 16321-1, Eye and face protection for occupational use — Part 1: General requirements
ISO 4007, Personal protective equipment — Eye and face protection — Vocabulary
ISO 21987, Ophthalmic optics — Mounted spectacle lenses
ISO 15190:2020, Medical laboratories — Requirements for safety
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
CAS 518-47-8
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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
aerosol (aerosolized)
colloidal suspension of liquid or solid particles dispersed in a gas (usually air), smoke or
fog
[SOURCE: ISO 15190: 2020, 3.2, modified – put in the singular and domain was added]
3.2
airborne
any biological material that is in the air (suspended or travelling)
Note 1 to entry: The biological material can include splashes, spurts, sprays, aerosols and droplets
3.3
airborne transmission
spread of an infectious agent caused by the dissemination of droplet nuclei (aerosols) that remain
infectious when suspended in the air over long distances and time
3.4
biological hazard
biological substance(s) that pose(s) a threat to the health of living organisms, primarily that of humans.
Note 1 to entry: This can include medical waste or samples of a microorganism, virus, or toxin (from a biological
source) that can affect human health.
3.5
cleaning
process to remove any type of contamination,
Note 1 to entry: The contamination can be visible or not
3.6
decontamination
procedure that eliminates or reduces microbial or toxic agents to a safe level with respect to the
transmission of infection or other adverse effects
3.7
disinfection
process to reduce the number of microorganisms (3.9), but not usually of bacterial spores, without
necessarily killing or removing all organisms
[SOURCE: ISO 15190: 2020; 3.9]
3.8
droplet
very small drop of liquid
Note 1 to entry: A small drop, such as a particle of moisture discharged from the mouth during coughing,
sneezing, speaking or released by agitation or spillage of a liquid source.
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
Note 2 to entry: These can transmit pathogens and cause infection by dispersion into the air.
Note 3 to entry: Particles intermediate in size between drops and aerosol can contain infectious microorganisms
and tend to quickly settle from the air such that risk of disease transmission is usually limited to persons in close
proximity to the droplet source.
Note 4 to entry: Particle size impacts on the amount of time it will remain in the air and this can potentially
change whilst suspended in air (due to evaporation)
3.9
microorganisms
microscopic organisms including protozoa and other parasites, fungi, archaea, bacteria, unicellular
algae, viruses and viroids
3.10
infectious microorganism
microorganism (3.9) capable of invading a susceptible host and multiplying in it
Note 1 to entry: Infectious microorganisms can but need not, cause a disease
3.11
pathogen
an infectious organism, usually microscopic, capable of causing disease in a host
3.12
re-usable
product intended to be cleaned and disinfected for multiple use
3.13
single use
use by a single person within a specified time frame or exposure situation
Note 1 to entry: Single use products are generally not appropriate for disinfection
3.14
splash
liquid scattered through the air or onto something
3.15
spray
very small drops of liquid carried in the air
3.16
spurt
sudden fast stream of liquid
EXAMPLE cough of mucus, leak from laboratory process, spurt from blood vessel in surgical/paramedical
settings
3.17
sterile
free from viable microorganisms
Note 1 to entry: In practice, no such statement regarding the absence of microorganisms can be proven.
3.18
sterilization
validated process used to render a product free from viable microorganisms
Note 1 to entry: The number of microorganisms that survive a sterilization process can be expressed in terms of
probability. While the probability may be reduced to a very low number, it can never be reduced to zero.
[SOURCE: ISO/TS 11139:2006, 2.47 – modified by addition of note to entry.]
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
3.19
Mean transmittance in the range 450 to 650 nm, τ
m,450-650
650 nm
 
 
τττ=  τ ()λλ d  +1
 
m,450-650 ∑
 
dλ
 
 450 nm 
where
τ(λ) is the spectral transmittance at wavelength λ and
dλ is the wavelength interval of the measurements
4 General requirements for protectors
4.1 General
Only those requirements that are different from or supplement the ISO 16321-1 specifications are given
in this document.
The following requirements from ISO 16321-1: 2021 shall be met:
— 4.2 Physiological compatibility
— 4.3 Construction and adjustment
— 4.5 Headform(s)
— 4.6 Mandatory and optional requirements
— 5.1 Field of view
— 5.2 Refractive power and prismatic power for plano lenses
— 5.3 Mounted prescription lenses
— 5.4 Single-vision ready-to-wear near-vision lenses (lenses with positive spherical power)
— 6.5 Scattered light
— 6.7 Anti-reflective coated lenses, optional
— 7.2 Headbands and harnesses
— 7.3 Quality of material and surface of mounted and unmounted lenses, visors and filters
— 7.8 Resistance to ignition
— 7.13 Resistance to fogging of lenses or filters (optional).
The additional requirements given in this document shall be met.
4.2 Ambient temperature
The protectors described in this document are intended for use at normal ambient temperatures
(23 ± 5) °C.
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
4.3 Replacement of components
Components of the protector that are intended for replacement, such as the face shield or headband,
shall be able to be replaced without compromising the compliance of the product.
Note 1 Components of a protector requiring the use of tools for their replacement should not be considered
replaceable.
4.4 Robustness
4.4.1 Principle
To ensure that no secondary hazard is generated from a blunt impact, complete eye protectors shall be
tested for robustness in accordance with this clause.
4.4.2 Testing
Eye protectors shall be tested in accordance to ISO 18526-3: 2020, 7.3.1, at (23 ± 5) °C, using a steel ball
+0,03
of nominal diameter 16 mm and mass not less than 16 g dropped from a height of 1,27 m at the
()
following impact points:
a) the left eye, frontal;
b) the right eye, frontal.
Frontal impact; The ball is directed perpendicular to the frontal plane through the two corneal apices
(denoted by X in Figures 1 and 2) to anywhere within an area of (10 ± 1) mm radius centred on the
corneal apex. This is carried out for the right and the left eyes.
The headform may be moved horizontally and vertically to select any single impact point lying within
this (10 ± 1) mm of the specified impact centres. New protectors may be used for each individual
impact. In the case of failure after multiple impacts on the same test sample, one new test sample for
each individual impact point shall be used.
4.4.3 Failure criteria
After testing for robustness from the front in accordance with Clause 4.4.1, the following defects shall
not be allowed when inspected in accordance with ISO 18526-3:2020, 6.1:
a) cracking through the entire thickness into two or more pieces; or
b) the protector separates into two or more pieces; or
c) material becomes detached from the surface opposite to that impacted.
Protectors complying with ISO 16321-1: 2021; - 7.4 exceed these requirements and therefore do not
need to be re-assessed to their robustness.
Note 1 A deformation of the lens is allowed.
EDITORIAL NOTE: The intention of this clause is to ensure that no secondary hazard is introduced from cracked
or fractured lenses. Comment is invited specifically on the appropriateness of this clause.
4.5 Cleaning
The procedure for cleaning to maintain the visual performance of the protector during use, as described
in the information to be supplied by the manufacturer and using the manufacturer's recommended
process and products, if any, shall not impair the performance of the protectors. Compliance with the
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
requirements shall be carried out after subjecting the protector to the cleaning procedures according
to the information to be supplied by the manufacturer.
Note 1 Certain cleaning methods may cause deterioration of the protector. This could be seen as impaired
optical performance (e.g., development of opacity of the lens) and reduced mechanical strength of the frame or
lens holder (increased brittleness).
4.6 Product disinfection for re-usable protectors
4.6.1 Principle
This clause applies to protectors intended to be disinfected and re-used. A minimum of two protectors
shall be tested according to the method provided by the manufacturer.
Protectors intended to be re-usable shall be subjected to the disinfection procedure specified by
the manufacturer. In the absence of a specified disinfection method, protectors shall be exposed to
the following chemicals; 70 % Ethanol, Benzalkonium chloride (0,5 % ± 0,05) %, Didecyl dimethyl
ammonium chloride (0,5 % ± 0,05) %, Polyhexamethylene biguanide (PHMB) (0,10 % ± 0,05) %.
Products intended to be re-used shall be marked with the appropriate marking according to Clause 8.
Note 1 Protectors should only to be re-used when it is acceptable according to local guidelines and standards.
Where the manufacturer claims that the product is able to be disinfected, appropriate information should be
provided according to Clause 9.
Note 2 Certain disinfection methods may cause deterioration of the protector. This could be seen as impaired
optical performance (e.g., development of opacity of the lens) and reduced mechanical strength of the frame
or lens holder (increased brittleness). If the disinfection method specified is known to cause deterioration of
the product, the manufacturer should specify the number of disinfection cycles that the product is capable of
withstanding without deterioration of its intended performance.
4.6.2 UV-C disinfection
Products intended to be disinfected with the use of a UV-C radiation source (of wavelengths between
100 nm and 280 nm) shall comply with the requirements set out in (4.6.4) following disinfection with
a UV-C system or radiation source that has been tested to achieve the relevant disinfection standard.
4.6.3 Disinfection by other means
Products intended to be disinfected by other means that have been tested to achieve relevant disinfectant
standard, such as automated hydrogen peroxide process, shall comply with the requirements set out in
(4.6.4).
NOTE The appropriate disinfection method adopted must comply with local regulations and standards e.g.,
EN 17272: 2020.
4.6.4 Testing
A minimum of two protectors shall be tested for each chemical or method of disinfection.
After disinfection, including exposure to chemicals disinfectants in accordance with ISO 18526-3:2020,
6.17, followed by thorough rinsing in clean water and drying, the protectors shall continue to fulfil the
following requirements:
a) there shall be no visible distortion of the protector when assessed in accordance with
ISO 18526-3:2020, 6.6;
b) wide-angle scatter shall continue to comply with ISO 16321-1:2021, 6.5;
c) transmittance characteristics shall continue to comply with the requirements specified in 5.1,
including optional claims (if specified);
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
d) robustness shall continue to comply with 4.4;
e) one protector shall be assessed on one subject for aspects of practical performance. Continued
operation of any incorporated mechanisms shall be assessed. When worn by a trained observer,
the security of fastenings and retention shall be assessed when tested in accordance with
ISO 18526-3:2020, 6.5.
Products intended to be re-usable shall not include any components that are likely to absorb chemicals
or other irritants e.g., open cell foam. Products intended to be reusable shall be marked with the
appropriate marking according to Clause 8.
5 Physical optical properties for protectors
5.1 Transmittance
5.1.1 Lenses without deliberate filtering action
The transmittance of lenses without deliberate filtering action (i.e., without declared scale numbers)
shall comply with 5.1.2 and 5.1.3.
5.1.2 Luminous transmittance of lenses without deliberate filtering action
Lenses shall have a luminous transmittance, τ , not less than 80 % when tested according to
v, D65
ISO 18526-2:2020, Clause 7.
NOTE 1 this corresponds to a Category 0 sunglare eye protector in ISO 16321-1.
For lenses with a thickness of more than 2,0 mm and for multiple glazed protectors, the luminous
transmittance shall be not less than 75 %.
5.1.3 Assessment of colour
The spectral transmittance, τ(λ), in the range 450 nm and 650 nm, shall be not less than 0,80 τ ,
m,450-650
where τ is the mean spectral transmittance in the range 450 nm to 650 nm, when tested in
m,450-650
accordance with ISO 18526-2:2021, Clause 6.
NOTE Compliance with this clause guarantees compliance with the detection of signal lights requirement in
ISO 16321-1:2021, 6.1.
5.2 Sunglare filters
5.2.1 General
Sunglare filters are intended to reduce solar glare to a comfortable level and solar ultraviolet radiation
to a safe level. Sunglare filters shall be tested in accordance with ISO 18526-2:2020, Clauses 6, 7 and 8.
The UV requirements in Table 1 shall be met as appropriate.
5.2.2 Luminous and spectral transmittance and scale numbers
The luminous transmittance, as shown in Table 1, is based on the spectral distribution for CIE
standard illuminant D65 (see ISO 11664-2) and the CIE 1931 standard colorimetric observer (2°)
(see ISO/CIE 11664-1). The scale number for the UV filter is determined by the value of its luminous
transmittance in accordance with Table 1.
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
Table 1 — Transmittance requirements of sunglare filters
Scale number Wavelength range from 280 nm to 400 nm Visible spectral
range
Maximum solar Maximum solar Maximum mean Luminous Trans-
UV-B transmittance UV-A transmittance transmittance mittance
280 nm ≤ λ ≤ 315 nm 315 nm ≤ λ ≤ 380 nm 380 nm ≤ λ ≤ 400 nm τ
v, D65
(%) (%) (%) 380 nm ≤ λ ≤ 780 nm
(%)
G0 0,03 τ 0,5 τ 0,75 τ 100 > τ ≥ 80
v, D65 v, D65 v, D65 v, D65
G1 0,03 τ 0,5 τ 0,75 τ 80 > τ ≥ 43
v, D65 v, D65 v, D65 v, D65
G2 0,03 τ 0,25 τ 0,5 τ 43 > τ ≥ 18
v, D65 v, D65 v, D65 v, D65
G3 0,03 τ 0,25 τ 0,5τ 18 > τ ≥ 8
v, D65 v, D65 v v, D65 v, D65
NOTE 1: UV filters protect the wearer against solar ultraviolet radiation whilst permitting any visual task to be performed
safely and accurately. In particular, it is necessary to take care that the colour of the filter permits any necessary perception
of colour such as the detection of signal lights, markings and indicators and the evaluation of colour matches. UV filters
that do not conform to these criteria could lead to difficulties for users. For further information about the selection of the
correct protector refer to Annex A.
NOTE 2: The eye protectors have not been assessed for protection against UV-C exposure.
5.2.3 Marking of sunglare filters
Sunglare filters that meet the transmittance requirements given in Table 1 shall be marked by code
letters G. Filters that meet additionally the requirement that the spectral transmittance, τ in the range
v,
shall be within the range 1,20 τ to 0,80 τ when tested in accordance
450 nm to 650 nm, m,450-650 m,450-650
with ISO 18526-2: 2021, 6 shall be marked by code letters GS.
6 Physical and mechanical requirements for protectors
6.1 Area to be protected
The eye protector (combined lens and frame) shall cover the specified minimum area to be protected,
when assessed in accordance with ISO 18526-3:2020, 6.3 and 6.4 and the nominated headform.
Figures 1 and 2 and Tables 2 and 3 describe the minimum areas to be protected that are required
for the individual coverage areas defined as Level I or II, or II+. The dimensions of the headforms are
defined in ISO 18526-4.
Level I: Basic, eyes only
Level II: Eyes, nose and mouth, with the nasal and mouth protection area defined by the area ABCD.
Level II+: Eyes, nose and mouth (extended wear), with the rectangular nasal and mouth protection area
defined by the box ABCD.
NOTE 1 Annex A provides guidance about different environments in which hazards exist and about the
appropriate level of protection.
NOTE 2 Level II protection may be provided by a combination of PPE. Where aerosol protection is required,
nose and mouth protection should be tested in accordance with the relevant ISO 16900 standards.
NOTE 3 Level II+ protection is provided for periods of extended wear that may result in a secondary hazard
for the wearer associated with biological hazards being transported into the mouth, e.g., from sweat dripping
down.
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
6.1.1 Area to be protected: Level I
Key
1 frontal eye protection zone
2 lateral eye protection zone
3 front surface of protector lens
corneal apices (centres of the ellipse)
lateral canthus
resting point of the sides
a−e As defined in Table 2.
Figure 1 — Minimum area to be protected for Level I eye protector
Table 2 — Dimensions of orbital protection zone (Level I) for individual headforms based on
interpupillary distance and corneal apex position
Tolerance on dimensions ±0,5 mm
Dimensions in mm
Dimensions Headform
1-C12 1-S 1-M 1-L 2-S 2-M 2-L
see Figure 1
a
a 58 60 64 68 63 64 70
b 24 36 40 42 33 35 40
c 20 25 28 29 23 24 28
d 8 9 12 13 7 8 9
e 10 mm around lateral canthus location 10 mm around lateral canthus location
a
Dimension a is the same as dimension D in ISO 18526-4:2020, Table 2 and Table 3.
NOTE There are no dimensions available for headforms 2-C12.
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
6.1.2 Area to be protected: Level II and Level II+
Key
1 frontal eye protection zone
2 lateral eye protection zone
3 front surface of protector lens
corneal apices (centres of the ellipse)
lateral canthus
resting point of the sides
a−g
As defined in Table 3.
x, z
ABCD extended coverage Level II and level II+ (editing note – to be changed for the next stage for clarification)
Figure 2 — Minimum area to be protected for Level II and Level II+ protector
Table 3 — Dimensions of protection zone (Level II and II+) for individual headforms based on
interpupillary distance and corneal apex position
Tolerance on dimensions ±0,5 mm
Dimensions in mm
Dimensions Headform
1-C12 1-S 1-M 1-L 2-S 2-M 2-L
see Figure 1
a
a 58 60 64 68 63 64 70
b 32 36 40 42 33 35 40
c 26 30 33 35 27 29 33
d 8 9 12 13 7 8 9
e 10 mm around lateral canthus location 10 mm around lateral canthus location
f 17 19 21 24 20 22 22
g 29 30 32 34 32 32 35
z 44 57 64 67 54 57 62
x 64 80 89 92 77 82 87
a
Dimension a is the same as dimension D in ISO 18526-4:2020, Table 2 and Table 3.
NOTE There are no dimensions available for headforms 2-C12.
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
6.2 Protection against spurt and spray
Complete protectors shall meet the requirements for Level I, II or II+ coverage (depending on which is
claimed) when tested in accordance with the method specified in clause 7 using the orientations and
aim points defined below:
a) Straight shot: Headform vertical and forward facing with the aim point at the midpoint of the line
between the two corneal vertices;
b) Up shot: Headform rotated about the horizontal axis through the midpoint of the 2 corneal vertices
to face (30 ± 1)° upwards with the aim point (25,0 ± 0,5) mm below the midpoint of the line between
the two corneal vertices;
c) Down shot: Headform rotated about the horizontal axis through the midpoint of the 2 corneal
vertices to face (30 ± 1)° downwards with the aim point (50,0 ± 0,5) mm above the midpoint of the
line between the two corneal vertices;
d) Left shot: Headform rotated about the vertical axis passing through the midpoint of the 2 corneal
vertices to face (55 ± 1)° to the right with the aim point to be the lateral canthus of the left eye (+ in
Figure 1); and
e) Right shot: Headform rotated about the vertical axis passing through the midpoint of the 2 corneal
vertices to face (55 ± 1)° to the left with the aim point to be the lateral canthus of the right eye (+
in Figure 1). Upon testing, protectors shall be considered to be satisfactory, if when observed by a
trained observer using a UV-A source to illuminate, if necessary, no biofluid simulant can be seen in
the area to be protected (Level I or II).
6.3 Protection from aerosols (optional)
6.3.1 General
Where aerosol transmission is possible, there is an increased risk not only to the eyes and face, but also
to the respiratory system. PPE that reduces the risks for both hazards to an acceptable level shall be
considered.
6.3.2 Aerosol Protection for Level I Area to be protected
Where aerosol protection is claimed, when tested in accordance with ISO 18526-3: 2020. 6.15,
protectors shall be considered satisfactory if no pink or crimson coloration appears in the area covered
by the protector. No account shall be taken of any such coloration up to a distance of 6 mm inside the
edges of the protector.
6.3.3 Aerosol protection for Level II or II+ Area to be protected
Where aerosol protection is claimed for Level II or II+, then a combination of PPE providing protection
to the eyes, that complies with 6.3.1, and protection to the respiratory system that complies with the
appropriate standard for respiratory protection should be considered.
NOTE For additional information, including information about appropriate respiratory protection and
issues relating to compatibility, please refer to relevant national standards and health authority guidelines; these
include:
ISO 1715: 2009, Selection, use and maintenance of respiratory devices
ISO 15190:2020 Medical laboratories — Requirements for safety
ISO TS 20141 Personal Safety— Personal Protective Equipment — Guidelines on Compatibility Testing of
PPE.
oSIST prEN ISO 16321-4:2023
ISO/DIS 16321-4:2023(E)
7 Spurt and spray test
7.1 Principle
This test is intended to demonstrate that a protector prevents spurts and sprays of liquid from reaching
the specified area to be protected as defined in 6.1.
7.2 Reagents, materials and apparatus
7.2.1 Headform
The appropriate headform complying to ISO 18526-4 covered by a layer of polyurethane.
7.2.2 Volumetric flask
Volumetric flask of nominal capacity 1,0 l.
7.2.3 Magnetic stirrer
Magnetic stirrer (or other equivalent equipment) appropriate to the size of the volu
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