FprEN ISO 374-5

Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO/FDIS 374-5:2024)

This document specifies the requirements and test methods for protective gloves intended to protect the user against micro-organisms.
NOTE            If other protection features are needed, e.g. chemical risks, mechanical risks, thermal risks, electrostatic dissipation etc., the appropriate specific performance standard is used in addition. Further information on protective gloves standards can be found in the ISO 21420:2020+Amd 1:2022

Schutzhandschuhe gegen gefährliche Chemikalien und Mikroorganismen - Teil 5: Terminologie und Leistungsanforderungen für Risiken durch Mikroorganismen (ISO/FDIS 374-5:2024)

Dieses Dokument legt die Anforderungen und Prüfverfahren für Schutzhandschuhe fest, die zum Schutz von Anwendern gegen Mikroorganismen vorgesehen sind.
ANMERKUNG   Wenn weitere Schutzmerkmale, z. B. chemische Risiken, mechanische Risiken, thermische Risiken, elektrostatische Entladung, erforderlich sind, wird zusätzlich die entsprechende spezifische Leistungsnorm verwendet. Weitere Informationen zu Schutzhandschuh-Normen können in ISO 21420:2020+Amd 1:2022 gefunden werden.

Gants de protection contre les produits chimiques dangereux et les micro-organismes - Partie 5: Terminologie et exigences de performance pour les risques par les micro-organismes (ISO/FDIS 374-5:2024)

Le présent document spécifie les exigences et les méthodes d'essai pour les gants de protection destinés à protéger l'utilisateur contre les micro-organismes.
NOTE            Si d'autres fonctions de protection sont nécessaires, par exemple les risques mécaniques, les risques thermiques, la dissipation électrostatique, etc., la norme de performance spécifique appropriée est utilisée en complément. Des informations supplémentaires sur les normes concernant les gants de protection sont disponibles dans l'ISO 21420:2020+Amd 1:2022

Varovalne rokavice za zaščito pred nevarnimi kemikalijami in mikroorganizmi - 5. del: Izrazje in zahtevane lastnosti za zaščito pred tveganji, povezanimi z mikroorganizmi (ISO/FDIS 374-5:2024)

General Information

• Status: Not Published
• Publication Date: 15-Sep-2024
• ICS: 01.040.13 - Environment. Health protection. Safety (Vocabularies)
• ICS: 13.340.40 - Hand and arm protection
• Technical Committee: CEN/TC 162 - Protective clothing including hand and arm protection and lifejackets
• Drafting Committee: CEN/TC 162/WG 8 - Protective gloves
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 13-Jun-2024
• Completion Date: 13-Jun-2024
• Directive: 2016/425 - Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC
• Mandate: M/571 - COMMISSION IMPLEMENTING DECISION of 19.11.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards personal protective equipment in support of Regulation (EU) 2016/425 of the European Parliament and of the Council
• Mandate: M/571 AMD 1 - Personal Protective Equipement
• Ref Project: kSIST FprEN ISO 374-5:2024 - Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO/FDIS 374-5:2024)

Relations

• Revises: EN ISO 374-5:2016 - Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
• Effective Date: 19-Jan-2023

Overview

FprEN ISO 374-5 (ISO 374-5) defines terminology, performance requirements and test methods for protective gloves against micro‑organisms. The standard is part of the ISO 374 series on gloves for dangerous chemicals and micro‑organisms and is intended to ensure gloves form an effective barrier to bacteria, viruses and fungi. It also explains marking and information manufacturers must supply, and how this work relates to PPE regulatory requirements.

Key topics and technical requirements

• Scope: Requirements and test methods for gloves intended to protect the user against micro‑organisms. If other hazards (chemical, mechanical, thermal, electrostatic) apply, additional specific standards should be used.
• Sampling: Test specimens are taken from the palm area; for gloves ≥ 400 mm with a protective cuff, an additional sample near the cuff is required. Seamed hand areas are included in sampling.
• Penetration testing: Whole‑glove tests (fingers, palm, back, cuff) use ISO 374‑2 methods to check for leaks-gloves must not leak.
• Viral challenge: Virus protection is verified by ISO 16604 Procedure B using the Phi‑X174 bacteriophage. Acceptable performance is no detectable transfer (<1 PFU/ml) in the assay titre.
• Dexterity: Gloves must meet a minimum dexterity performance (at least level 1) when tested per ISO 21420 (clause 6.2), balancing protection and usability.
• Marking and labelling: A mandatory micro‑organism pictogram (ISO 7000 symbol) is required. Where applicable, manufacturers must indicate compliance and provide standardized warnings such as “Not tested against viruses” (if not tested) or “For single use only” (if no decontamination info).
• Manufacturer information: Reusable gloves require decontamination instructions; otherwise the glove is intended for single use and must be labelled accordingly.

Practical applications and users

This standard is intended for:

• Glove manufacturers designing and certifying microbiological protective gloves
• Test laboratories performing penetration and viral challenge tests
• PPE conformity assessors and notified bodies referencing EU Regulation (EU) 2016/425
• Occupational health and safety professionals in healthcare, laboratories, pharmaceuticals, food processing, cleaning and emergency response who specify gloves for biological risks

Using ISO 374‑5 helps ensure products provide validated barrier protection while meeting regulatory and market expectations for biological PPE.

Related standards

• ISO 374‑2: Determination of resistance to penetration
• ISO 16604: Viral penetration test (Phi‑X174)
• ISO 21420: General requirements and test methods for protective gloves
• ISO 7000: Graphical symbols for marking
• Other parts of ISO 374 (Part 1, Part 4, Part 6) for chemical risks, degradation and sector‑specific requirements

Keywords: protective gloves, micro‑organisms, ISO 374‑5, viral penetration, bacteria, fungi, ISO 374‑2, ISO 16604, ISO 21420, PPE, glove marking.

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 374-5:2022
01-december-2022
Varovalne rokavice za zaščito pred nevarnimi kemikalijami in mikroorganizmi - 5.
del: Izrazje in zahtevane lastnosti za zaščito pred tveganji, povezanimi z
mikroorganizmi (ISO/DIS 374-5:2022)
Protective gloves against dangerous chemicals and micro-organisms - Part 5:
Terminology and performance requirements for micro-organisms risks (ISO/DIS 374-
5:2022)
Schutzhandschuhe gegen gefährliche Chemikalien und Mikroorganismen - Teil 5:
Terminologie und Leistungsanforderungen für Risiken durch Mikroorganismen (ISO/DIS
374‑5:2022)
Gants de protection contre les produits chimiques dangereux et les micro-organismes -
Partie 5: Terminologie et exigences de performance pour les risques par les micro-
organismes (ISO/DIS 374-5:2022)
Ta slovenski standard je istoveten z: prEN ISO 374-5
ICS:
13.340.40 Varovanje dlani in rok Hand and arm protection
oSIST prEN ISO 374-5:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 374-5:2022
oSIST prEN ISO 374-5:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 374-5
ISO/TC 94/SC 13 Secretariat: SNV
Voting begins on: Voting terminates on:
2022-10-12 2023-01-04
Protective gloves against dangerous chemicals and micro-
organisms —
Part 5:
Terminology and performance requirements for micro-
organisms risks
Gants de protection contre les produits chimiques dangereux et les micro-organismes —
Partie 5: Terminologie et exigences de performance pour les risques contre les micro-organismes
ICS: 01.040.13; 13.340.40
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 374-5:2022(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 2022

oSIST prEN ISO 374-5:2022
ISO/DIS 374-5:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 374-5
ISO/TC 94/SC 13 Secretariat: SNV
Voting begins on: Voting terminates on:

Protective gloves against dangerous chemicals and micro-
organisms —
Part 5:
Terminology and performance requirements for micro-
organisms risks
Gants de protection contre les produits chimiques dangereux et les micro-organismes —
Partie 5: Terminologie et exigences de performance pour les risques contre les micro-organismes
ICS: 01.040.13; 13.340.40
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
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: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 374-5:2022(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 2022

oSIST prEN ISO 374-5:2022
ISO/DIS 374-5:2022(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Sampling . 2
4.1 Sampling for viral penetration testing . 2
4.2 Sampling for bacteria/fungi penetration testing . 3
5 Performance requirement.3
5.1 General requirements . 3
5.2 Dexterity . 3
5.3 Penetration . 3
5.4 Protection against viruses . 3
5.5 Requirements for different protection types of gloves . 3
6 Marking . . 3
6.1 Marking of gloves protecting against bacteria and fungi . 4
6.2 Marking of gloves protecting against viruses, bacteria and fungi . 4
7 Information supplied by the manufacturer . 4
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Regulation (EU) 2016/425 aimed to be covered .6
iii
oSIST prEN ISO 374-5:2022
ISO/DIS 374-5:2022(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
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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
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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 on 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 the following URL: www.iso.org/iso/foreword.html.
ISO 374-5 was prepared by the European Committee for Standardization (CEN) in collaboration with
ISO Technical Committee ISO/TC 94, Personal safety — Protective clothing and equipment, Subcommittee
SC 13 Protective clothing in accordance with the Agreement on technical cooperation between ISO and
CEN (Vienna Agreement).
ISO 374 consists of the following parts, under the general title Protective gloves against dangerous
chemicals and
...