Eye and face protection - Part 4: Protection against biological hazards (ISO/FDIS 16321-4:2025)

This document specifies minimum requirements for light-weight protectors designed to provide protection for the eyes or eyes and face from biological hazards, such as pathogenic micro-organisms in human or other animal bodily fluids that can deposit onto the face or eyes.
NOTE 1        Typical scenarios for use include healthcare, retail and transport settings.
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 cover the respiratory equipment required for protection against aerosols, which can be used in conjunction with these eye protectors, and for which other standards apply.
This document does not apply to
—     protectors intended for protection from specific hazards, e.g. mechanical hazards, harmful artificial optical radiation, dusts, molten metals, heat, flame, hot solids, harmful gases, vapours (refer to ISO 16321-1 to ISO 16321-3),
—     protectors specifically for sports (refer to the ISO 18527 series),
—     protectors for lasers (refer to ISO 19818-1), and
—     respiratory protection against aerosols (refer to ISO/TS 16975-4).
NOTE 2        Guidance related to the specific selection, use and maintenance is provided in Annex A.
NOTE 3        Where eye and face protection is incorporated in protective equipment, such as a hood, full face respirators, powered air purifying respirators (PAPR) hoods and headtops, the relevant requirements of this document apply to the components providing eye and face protection.

Augen- und Gesichtsschutz für betriebliche Anwendungen - Teil 4: Zusätzliche Anforderungen zum Schutz vor biologischen Gefahren (ISO/FDIS 16321‑4:2025)

Dieses Dokument legt die Mindestanforderungen an Schutzgeräte fest, die zum Schutz der Augen oder der Augen und des Gesichts vor biologischen Gefährdungen, wie z.B. menschlichen oder tierischen Körperflüssig
keiten und Mikroorganismen, bestimmt sind.
Dieses Dokument legt die Anforderungen für Produkte oder Komponenten fest, die sowohl zum einmaligen Gebrauch (Einweg) als auch zur Wiederverwendung (desinfizierbar) bestimmt sind.
Dieses Dokument gilt für alle afokalen (Plan-Sichtscheiben) und Schutzgeräte in Form von Korrektionssicht
scheiben und deren Komponenten.
Dieses Dokument gilt nicht für:
- Schutzgeräte zum Schutz vor bestimmten Gefährdungen, z.B. Stöße von Teilchen mit hoher Geschwindig
keit, schädliche künstliche optische Strahlung, Staub, geschmolzene Metalle, Hitze, Flammen, heiße
körper, schädliche Gase, Dämpfe (siehe ISO16321, Teil1 bis3);
- Schutzgeräte, die speziell für sportliche Aktivitäten vorgesehen sind (siehe Normreihe ISO18527);
- Schutzgeräte für den Umgang mit Lasern (siehe ISO19818-1);
- Atemschutz gegen Aerosole (siehe Normreihe ISO16900).
ANMERKUNG1 Eine Anleitung zur richtigen Auswahl, Verwendung und Pflege ist in AnhangA enthalten.
ANMERKUNG2 Wenn Augen- und Gesichtsschutz in Schutzausrüstungen wie Kapuze, Atemschutzgeräte, die das ganze Gesicht bedecken, Gebläseatemschutz-Geräte (en: powered air-purifying respirator, PAPR) und Kopfbedeckungen inte
griert sind, gelten die entsprechenden Anforderungen dieser Norm für die Komponenten, die Augen und Gesicht schützen.

Protection des yeux et du visage à usage professionnel - Partie 4: Exigences complémentaires pour la protection contre les risques biologiques (ISO/FDIS 16321-4:2025)

Le présent document spécifie les exigences minimales applicables aux protecteurs légers conçus pour protéger les yeux ou les yeux et le visage contre les risques biologiques, tels que les micro-organismes pathogènes présents dans les fluides corporels humains ou d'autres animaux et qui peuvent se déposer sur le visage ou les yeux.
NOTE 1        Les scénarios types d'utilisation comprennent les soins de santé, le commerce de détail et les transports.
Le présent document spécifie les exigences relatives aux produits ou composants à usage unique (jetables) et réutilisables (désinfectables).
Le présent document s'applique à tous les protecteurs équipés de verres afocaux (non correcteurs) et de verres correcteurs, ainsi qu'à leurs composants.
Le présent document ne couvre pas l'équipement respiratoire requis pour la protection contre les aérosols, qui peut être utilisé conjointement avec ces protecteurs de l'œil, et pour lequel d'autres normes s'appliquent.
Le présent document ne s'applique pas:
—     aux protecteurs destinés à protéger contre des risques spécifiques, par exemple les risques mécaniques, les rayonnements optiques artificiels nocifs, les poussières, les métaux fondus, la chaleur, les flammes, les solides chauds, les gaz nocifs, les vapeurs (voir ISO 16321-1 à ISO 16321-3);
—     aux protecteurs spécialement destinés à un usage sportif (voir la série ISO 18527);
—     aux protecteurs contre le rayonnement laser (voir ISO 19818-1); et
—     à la protection respiratoire contre les aérosols (voir ISO/TS 16975-4).
NOTE 2        Des recommandations relatives au choix, à l'utilisation et à l'entretien spécifiques sont fournies à l'Annexe A.
NOTE 3        Lorsque la protection des yeux et du visage est intégrée à un équipement de protection, tel qu'une capuche, un masque complet, les capuches et interfaces respiratoires d'appareil de protection respiratoire d’épuration d’air propulsé (PAPR), les exigences pertinentes du présent document s'appliquent aux composants qui offrent une protection des yeux et du visage.

Zaščita za oči in obraz - 4. del: Zaščito pred biološkimi nevarnostmi (ISO/FDIS 16321-4:2025)

General Information

Status
Not Published
Public Enquiry End Date
22-Oct-2023
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
22-Aug-2025
Due Date
10-Oct-2025
Completion Date
08-Sep-2025
Draft
oSIST prEN ISO 16321-4:2023 - BARVE
English language
35 pages
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Standards Content (Sample)


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
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
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 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
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 16321-4:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
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 .
...

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