kSIST FprEN ISO 374-5:2024
(Main)Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO/FDIS 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)
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
- Public Enquiry End Date
- 30-Dec-2022
- Technical Committee
- OVP - Personal protecting equipment
- Current Stage
- 5020 - Formal vote (FV) (Adopted Project)
- Start Date
- 24-Apr-2024
- Due Date
- 12-Jun-2024
- Completion Date
- 05-Jun-2024
Relations
- Effective Date
- 18-Jan-2023
- Effective Date
- 23-Jun-2021
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.
Frequently Asked Questions
kSIST FprEN ISO 374-5:2024 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO/FDIS 374-5:2024)". This standard covers: 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
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
kSIST FprEN ISO 374-5:2024 is classified under the following ICS (International Classification for Standards) categories: 01.040.13 - Environment. Health protection. Safety (Vocabularies); 13.340.40 - Hand and arm protection. The ICS classification helps identify the subject area and facilitates finding related standards.
kSIST FprEN ISO 374-5:2024 has the following relationships with other standards: It is inter standard links to SIST EN ISO 374-5:2017, SIST EN ISO 374-5:2017. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
kSIST FprEN ISO 374-5:2024 is associated with the following European legislation: EU Directives/Regulations: 2016/425; Standardization Mandates: M/571, M/571 AMD 1. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase kSIST FprEN ISO 374-5:2024 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
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
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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 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
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 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
...
Die Standardisierung von Schutzhandschuhen, insbesondere in Bezug auf Gefahrstoffe und Mikroorganismen, wird durch das Dokument kSIST FprEN ISO 374-5:2024 präzise geregelt. Dieser Standard legt die Anforderungen und Prüfmethoden für Schutzhandschuhe fest, die darauf abzielen, Benutzer vor Mikroorganismen zu schützen. Der Fokus auf Mikroorganismen-Risiken ist besonders relevant, da in vielen Branchen, wie dem Gesundheitswesen und der Lebensmittelindustrie, ein effektiver Schutz unerlässlich ist. Ein wesentlicher Stärke dieses Standards liegt in der klaren Definition der Terminologie und der Festlegung von Leistungskriterien, die es Herstellern ermöglichen, Schutzhandschuhe zu produzieren, die höchsten Sicherheitsanforderungen genügen. Die detaillierten Testmethoden stellen sicher, dass die Handschuhe nicht nur theoretisch, sondern auch in praktischen Anwendungen effektiv gegen Mikroorganismen wirken. Dies erhöht das Vertrauen der Anwender in die Sicherheit der Produkte. Zudem ist die Relevanz des Standards kSIST FprEN ISO 374-5:2024 in einem Umfeld, in dem chemische, mechanische und thermische Risiken ebenfalls häufig auftreten, von großer Bedeutung. Während dieser Standard spezifisch auf mikrobiologische Risiken eingeht, erinnert er auch daran, dass zusätzliche Schutzmerkmale in Betracht gezogen werden sollten. Hierbei wird auf die Notwendigkeit verwiesen, die entsprechenden spezifischen Leistungssstandards zu konsultieren, um einen umfassenden Schutz zu gewährleisten. Insgesamt bietet das Dokument eine essentielle Grundlage für die Hersteller von Schutzhandschuhen und trägt dazu bei, die Sicherheit am Arbeitsplatz signifikant zu erhöhen. Die Einhaltung der Normen ist entscheidend, um sowohl den gesetzlichen Anforderungen als auch den Erwartungen der Verbraucher gerecht zu werden.
The kSIST FprEN ISO 374-5:2024 standard is a pivotal document that delineates the requirements and test methods for protective gloves aimed at safeguarding users from micro-organism risks. This standard is particularly relevant in settings where exposure to harmful biological agents is a concern, enhancing workplace safety and health. One of the key strengths of this standard is its comprehensive approach to terminology and performance evaluation for protective gloves. By clearly defining micro-organism risks, it establishes a foundation for the effective use and testing of gloves, ensuring that they meet necessary safety benchmarks. The detailed performance requirements provided facilitate manufacturers in developing gloves that can adequately protect against various types of biological threats. Furthermore, the standard's range of applicability is noteworthy, as it underscores that while it focuses on micro-organisms, other protection features-like chemical, mechanical, and thermal risks-can be addressed by referring to additional specific performance standards. This multilevel approach signifies the standard's versatility and its importance within the broader framework of personal protective equipment regulations. The alignment of kSIST FprEN ISO 374-5:2024 with international standards enhances its credibility and relevance in the global market. By adhering to the protocols established in this document, manufacturers can ensure that their products are compliant with international safety norms, thereby increasing marketability and trust among users. The inclusion of specific test methods not only promotes consistency across products but also ensures that users can rely on the gloves’ effectiveness against micro-organisms. As the relevance of health and safety standards continues to grow, particularly in the context of global health concerns, the importance of such a standard cannot be overstated. In summary, the kSIST FprEN ISO 374-5:2024 standard serves as a critical instrument for establishing safety measures against micro-organism risks through protective gloves, endowed with clear terminology and robust performance requirements essential for industry compliance and user protection.
kSIST FprEN ISO 374-5:2024は、有害な化学物質や微生物からの保護のための手袋に関する重要な標準です。この標準は、微生物リスクに対する保護手袋の要求事項および試験方法を明確に定義しており、使用者が安全に作業を行うための基準を提供しています。 このドキュメントの主な強みは、その範囲の明確さと実用性です。微生物リスクに特化しているため、医療現場や研究施設、さらには食品産業など、多岐にわたる分野での応用が期待されます。また、さまざまな環境での使用に対して、具体的な性能要件を設けることで、使用者の安全を強化しています。 さらに、この標準は他の保護機能が必要な場合、例えば化学的リスクや機械的リスク、熱的リスク、静電気放散などに対応するために、適切な特定の性能基準と併用されることを推奨しています。これは、包括的な安全対策を希望する企業や機関にとって、非常に有用な情報となります。 ISO 21420:2020+Amd 1:2022に基づく保護手袋の標準に関する詳細情報も提供しているため、興味を持つユーザーにとって、この標準は更なる理解を深める助けとなるでしょう。総じて、kSIST FprEN ISO 374-5:2024は、現代の安全要求に応えるための基盤となる重要な文書であり、その関連性は今後ますます高まると考えられます。
kSIST FprEN ISO 374-5:2024 표준은 위험한 화학 물질과 미생물로부터 사용자를 보호하기 위한 보호 장갑의 성능 요건 및 시험 방법을 명확히 규정하고 있습니다. 이 표준의 주요 초점은 미생물 위험으로부터의 보호에 있으며, 이는 의료, 실험실 및 기타 관련 산업에서의 필수적인 안전 요구사항으로, 관련 산업에 큰 기여를 합니다. 표준의 강점은 그 명확한 용어 정의와 요구사항에 있으며, 이는 사용자가 올바른 보호 장갑을 선택하는 데 도움을 줍니다. 또한, 다양한 테스트 방법은 장갑의 성능을 객관적으로 평가할 수 있도록 해주며, 이를 통해 사용자 안전을 극대화하는 데 기여합니다. 이 문서는 ISO 21420:2020+Amd 1:2022와 같이 다른 특정 보호 기능을 추가로 요구할 경우 참고할 수 있는 기준을 제시하고 있어, 종합적인 안전성 확보에 중요한 역할을 합니다. kSIST FprEN ISO 374-5:2024의 실용성은 특히 미생물에 대한 위험에 초점을 맞추고 있는 만큼, 바이러스, 세균 및 기타 미생물에 대한 보호가 필수적인 현재의 상황에서 그 재적합성은 더욱 강조됩니다. 이 표준은 사용자가 적절한 보호를 받을 수 있도록 하기 위한 실질적인 기준을 제공하여, 산업별로 필요한 보호 장갑의 성능 요구를 충족할 수 있도록 돕습니다.
La norme kSIST FprEN ISO 374-5:2024 se concentre sur les gants de protection contre les micro-organismes, spécifiant les exigences et les méthodes de test nécessaires pour garantir que ces gants assurent une protection adéquate à l'utilisateur. Cette normalisation est particulièrement pertinente dans un contexte où la sécurité face aux risques biologiques est primordiale, notamment dans les secteurs de la santé, de l'industrie alimentaire et de la recherche scientifique. Un des points forts de cette norme réside dans sa précision et son exhaustivité concernant la terminologie et les exigences de performance. Elle permet d'établir des critères clairs pour évaluer l'efficacité des gants de protection, ce qui est essentiel pour assurer une sécurité optimale des utilisateurs. Les méthodes de test incluses dans le document garantissent une évaluation rigoureuse des capacités de protection des gants contre divers micro-organismes, renforçant ainsi la confiance des utilisateurs dans les équipements de protection individuelle. Il est également important de noter que la norme 374-5 ne couvre pas seulement les risques liés aux micro-organismes, mais elle souligne aussi la nécessité d'utiliser d'autres normes spécifiques si des exigences en matière de risques chimiques, mécaniques ou thermiques sont à considérer. Cela démontre l'intégration harmonieuse de kSIST FprEN ISO 374-5:2024 avec d'autres références pertinentes telles qu’ISO 21420:2020+Amd 1:2022, façonnant ainsi un cadre robuste pour la protection des utilisateurs dans des situations diversifiées. En résumé, kSIST FprEN ISO 374-5:2024 s'avère être une norme essentielle pour les professionnels ayant besoin de garantir la sécurité face aux risques biologiques, tout en offrant une liaison précieuse avec d'autres normes lorsqu'une protection supplémentaire est requise. Cette norme, par son détail et sa clarté, démontre une forte inadaptabilité à l'évolution des besoins de sécurité dans des environnements à risque.
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