SIST EN ISO 374-5:2017
(Main)Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (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)
ISO 374-5:2016 specifies the requirements and test methods for protective gloves intended to protect the user against micro-organisms.
NOTE If other protection features is to be needed, e.g. chemical risks, mechanical risks, thermal risks, electrostatic dissipation etc., the appropriate specific performance standard is to be used in addition. Further information on protective gloves standards can be found in the EN 420.
Schutzhandschuhe gegen gefährliche Chemikalien und Mikroorganismen - Teil 5: Terminologie und Leistungsanforderungen für Risiken durch Mikroorganismen (ISO 374-5:2016)
Dieser Teil von ISO 374 legt ein Prüfverfahren für den Widerstand gegen Penetration von Handschuhen fest, die vor Mikroorganismen schützen.
ANMERKUNG Wenn weitere Schutzmerkmale, z. B. chemische Risiken, mechanische Risiken, thermische Risiken, elektrostatische Entladung, erforderlich sind, muss zusätzlich die entsprechende spezifische Leistungsnorm verwendet werden. Weitere Informationen zu Schutzhandschuh-Normen können in EN 420 gefunden werden.
Gants de protection contre les micro-organismes - Partie 5: Terminologie et exigences de performance pour des risques par des micro-organisme (ISO 374-5:2016)
L'ISO 374-5:2016 spécifie une méthode d'essai permettant de déterminer la résistance à la pénétration des gants qui protègent contre les micro-organismes.
NOTE Si d'autres fonctions de protection doivent être couvertes, par exemple les risques mécaniques, les risques thermiques, la dissipation électrostatique, etc., il convient que la norme de performance spécifique appropriée soit utilisée en complément. Des informations supplémentaires sur les normes concernant les gants de protection peuvent se trouver dans l'EN 420.
Varovalne rokavice za zaščito pred nevarnimi kemikalijami in mikroorganizmi - 5. del: Izrazje in zahtevane lastnosti za zaščito pred tveganji, povezanimi z mikroorganizmi (ISO 374-5:2016)
Ta evropski standard določa preskusno metodo za rokavice, odporne proti predrtju, ki ščitijo pred mikroorganizmi. OPOMBA: Če je treba zajeti tudi druge zaščitne lastnosti, npr. kemične nevarnosti, mehanske nevarnosti, toplotne nevarnosti, elektrostatično razelektritev itd., je treba uporabiti tudi ustrezne standarde zmogljivosti, npr. EN 374-1, EN 388, EN 407, EN 16350 idr.
General Information
- Status
- Published
- Public Enquiry End Date
- 19-Jul-2015
- Publication Date
- 31-Jan-2017
- Technical Committee
- OVP - Personal protecting equipment
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 03-Jan-2017
- Due Date
- 10-Mar-2017
- Completion Date
- 01-Feb-2017
Relations
- Effective Date
- 18-Jan-2023
- Effective Date
- 23-Jun-2021
Overview
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) defines terminology, performance criteria and test methods for gloves intended to protect users from micro-organisms (bacteria, viruses, fungi). Published by CEN/ISO, this standard is part of the ISO 374 series addressing glove performance for biological and chemical hazards. It clarifies sampling, penetration and virus-resistance requirements and marking rules for certified gloves.
Key Topics and Requirements
- Scope and terminology: Defines “protective gloves against micro-organisms” and key terms for bacteria, virus and fungi.
- Sampling: Test specimens are taken from the palm area; for gloves ≥ 400 mm with a protective cuff, an additional sample is taken with its centre 80 mm from the cuff end. Seams in the hand area must be tested.
- Penetration testing: Gloves must not leak when tested per EN 374-2:2014 (clauses 7.2 and 7.3).
- Viral protection: Virus-protective gloves require testing according to ISO 16604:2004 Procedure B using the Phi-X174 bacteriophage; acceptable performance is no detectable transfer (< 1 PFU/ml) in the assay titre.
- Performance matrix:
- Gloves protecting against bacteria and fungi must meet general and penetration requirements.
- Gloves protecting against viruses, bacteria and fungi must meet general, penetration and virus-resistance requirements.
- Marking and information: Marking follows EN 420:2009; pictograms are specified for bacteria/fungi and for virus+bacteria+fungi protection. Manufacturers must supply relevant information with the product.
- Complementary standards: If other hazards (chemical, mechanical, thermal, electrostatic) are relevant, the appropriate performance standards must be applied in addition.
Practical Applications
- Selection and certification of medical, laboratory and clinical-use gloves where protection from infectious agents is required.
- Procurement specifications for healthcare facilities, diagnostic labs, biotechnology, pharmaceutical manufacturing, food safety and emergency responders.
- Test laboratories and manufacturers use the standard to design sampling plans, run penetration and viral-resistance tests, and label compliant gloves.
Who Uses This Standard
- PPE manufacturers and product developers
- Test laboratories and conformity assessment bodies
- Safety managers, procurement officers and compliance teams in healthcare, laboratory and industrial settings
- Regulators and certification bodies implementing EN/ISO requirements
Related Standards
- EN 374-2:2014 - Determination of resistance to penetration
- EN 420:2009 - Protective gloves - General requirements and test methods
- ISO 16604:2004 - Viral penetration test (Phi-X174 bacteriophage)
Keywords: EN ISO 374-5:2016, protective gloves, micro-organisms, virus protection, bacteria, fungi, penetration testing, EN 374-2, ISO 16604, EN 420, PPE, glove marking.
Frequently Asked Questions
SIST EN ISO 374-5:2017 is a standard 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 374-5:2016)". This standard covers: ISO 374-5:2016 specifies the requirements and test methods for protective gloves intended to protect the user against micro-organisms. NOTE If other protection features is to be needed, e.g. chemical risks, mechanical risks, thermal risks, electrostatic dissipation etc., the appropriate specific performance standard is to be used in addition. Further information on protective gloves standards can be found in the EN 420.
ISO 374-5:2016 specifies the requirements and test methods for protective gloves intended to protect the user against micro-organisms. NOTE If other protection features is to be needed, e.g. chemical risks, mechanical risks, thermal risks, electrostatic dissipation etc., the appropriate specific performance standard is to be used in addition. Further information on protective gloves standards can be found in the EN 420.
SIST EN ISO 374-5:2017 is classified under the following ICS (International Classification for Standards) categories: 13.340.40 - Hand and arm protection. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 374-5:2017 has the following relationships with other standards: It is inter standard links to kSIST FprEN ISO 374-5:2024, kSIST FprEN ISO 374-5:2024. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 374-5:2017 is associated with the following European legislation: EU Directives/Regulations: 2016/425, 89/686/EEC; Standardization Mandates: M/031. 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 SIST EN ISO 374-5:2017 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
01-marec-2017
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Protective gloves against dangerous chemicals and micro-organisms - Part 5:
Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
Schutzhandschuhe gegen gefährliche Chemikalien und Mikroorganismen - Teil 5:
Terminologie und Leistungsanforderungen für Risiken durch Mikroorganismen (ISO 374-
5:2016)
Gants de protection contre les micro-organismes - Partie 5: Terminologie et exigences
de performance pour des risques par des micro-organisme (ISO 374-5:2016)
Ta slovenski standard je istoveten z: EN ISO 374-5:2016
ICS:
13.340.40 Varovanje dlani in rok Hand and arm protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 374-5
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 01.040.13; 13.340.40
English Version
Protective gloves against dangerous chemicals and micro-
organisms - Part 5: Terminology and performance
requirements for micro-organisms risks (ISO 374-5:2016)
Gants de protection contre les micro-organismes - Schutzhandschuhe gegen Chemikalien und
Partie 5: Terminologie et exigences de performance Mikroorganismen - Teil 5: Terminologie und
pour des risques par des micro-organisme (ISO 374- Leistungsanforderungen für Risiken durch
5:2016) Mikroorganismen (ISO 374-5:2016)
This European Standard was approved by CEN on 24 September 2016.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 374-5:2016 E
worldwide for CEN national Members.
Contents Page
Europen foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 89/686/EEC . 4
Europen foreword
This document (EN ISO 374-5:2016) has been prepared by Technical Committee CEN/TC 162
“Protective clothing including hand and arm protection and lifejackets", the secretariat of which is held
by DIN, in collaboration with Technical Committee ISO/TC 94 "Personal safety - Protective clothing and
equipment".
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2017, and conflicting national standards shall be
withdrawn at the latest by May 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 374-5:2016 has been approved by CEN as EN ISO 374-5:2016 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 89/686/EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 89/686/EEC on the approximation of the laws of the
Member States relating to personal protective equipment.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of
this standard given in Table ZA confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations
Table ZA — Correspondence between this European Standard and Directive (Add the reference
and title of the Directive)
Essential Requirements (ERs) of Directive 89/686/EEC Clause(s)/ Qualifying
subclause(s remarks/
) of this EN Notes
1.4 Information supplied by the manufacturer Clause 7
PPE bearing one or more identification or recognition Clause 6
marks
2.12.
directly or indirectly relating to health and safety
Protection against dangerous substances and infective 5.2, 5.3 5.4
3.10
agents
3.10.2
Protection against cutaneous and ocular contact
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 374-5
First edition
2016-10-15
Protective gloves against dangerous
chemicals and micro-organisms —
Part 5:
Terminology and performance
requirements for micro-organisms
risks
Gants de protection contre les micro-organismes —
Partie 5: Terminologie et exigences de performance pour des risques
par des micro-organisme
Reference number
ISO 374-5:2016(E)
©
ISO 2016
ISO 374-5:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 374-5:2016(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 . 2
5 Performance requirement . 3
5.1 General requirements .
...
Die SIST EN ISO 374-5:2017 ist ein entscheidendes Dokument zur Normierung von Schutzhandschuhen, die speziell gegen Mikroorganismen gerichtet sind. Mit ihrem klar definierten Anwendungsbereich bietet diese Norm eine umfassende Richtlinie für die Anforderungen und Prüfmethoden, die bei der Entwicklung und Prüfung von Schutzhandschuhen zu beachten sind. Stärken der Norm liegen in der systematischen Aufstellung von terminologischen Definitionen sowie den Performance-Anforderungen, die die Sicherheit und Wirksamkeit dieser Schutzhandschuhe gewährleisten. Die Norm ist nicht nur relevant für Hersteller, sondern auch für Anwender, die im Gesundheitswesen oder in anderen Bereichen arbeiten, in denen ein Risiko durch Mikroorganismen besteht. Die spezifischen Anforderungen aus der ISO 374-5:2016 sind darauf ausgelegt, den Schutz des Benutzers optimal zu garantieren. Zudem ist es wichtig zu beachten, dass, wenn zusätzliche Schutzfunktionen benötigt werden, wie z.B. gegen chemische, mechanische oder thermische Risiken, die entsprechenden spezifischen Leistungsstandards herangezogen werden müssen. Dies hebt die Flexibilität und Anpassungsfähigkeit der Norm hervor, die in Kombination mit anderen Standards wie EN 420 eine ganzheitliche Sicherheitslösung bietet. Die Relevanz der SIST EN ISO 374-5:2017 wird durch die steigenden Anforderungen an persönliche Schutzausrüstungen unterstrichen, insbesondere in Zeiten, in denen die Exposition gegenüber gefährlichen Mikroorganismen an Bedeutung gewinnt. Die klare Struktur der Norm unterstützt Hersteller dabei, Produkte zu entwickeln, die nicht nur den aktuellen Sicherheitsanforderungen entsprechen, sondern auch das Vertrauen der Nutzer in die Qualität und Sicherheit ihrer Schutzausrüstung stärken.
The standard SIST EN ISO 374-5:2017 offers a comprehensive framework for assessing and ensuring the performance of protective gloves against micro-organism risks. Its primary focus on terminology and performance requirements specifically tailored to micro-organisms reflects its significance in various industries where worker safety is paramount, such as healthcare, laboratories, and food processing. One of the notable strengths of this standard is its detailed specification of requirements and test methods that establish a baseline for the effectiveness of gloves in protecting users from micro-organisms. This ensures that manufacturers adhere to stringent criteria that enhance the reliability and performance of their products. By setting clear guidelines, the standard helps mitigate occupational exposure to harmful pathogens, which is crucial in today’s health-conscious environment. Additionally, the relevance of SIST EN ISO 374-5:2017 is underscored by its emphasis on the necessity of complementary standards for other risks. While it provides a focused approach to micro-organism protection, it acknowledges that additional protective features may be required for risks associated with chemicals, mechanics, or thermal exposure, among others. This layered approach empowers users to select gloves that meet comprehensive safety requirements, enhancing overall protection. Furthermore, integration with EN 420 for additional glove performance specifications reinforces the standard’s credibility and facilitates a holistic understanding of protective glove usage across various applications. The alignment with broader international benchmarks ensures that users are equipped with gloves that meet recognized safety standards, thereby fostering confidence in the protection they provide. In summary, SIST EN ISO 374-5:2017 is a critical standard in the realm of protective gloves, particularly concerning risks posed by micro-organisms. Its clarity, comprehensive test methodologies, and compatibility with other protective standards distinctly position it as an essential resource for manufacturers and users focused on safety and health in environments prone to microbial exposure.
La norme SIST EN ISO 374-5:2017 est essentielle dans le domaine des équipements de protection individuelle, spécifiquement axée sur les gants protecteurs contre les micro-organismes. En établissant des exigences claires et des méthodes d'essai pour évaluer les performances des gants, cette norme s'assure que les utilisateurs bénéficient d'une protection adéquate lorsqu'ils sont exposés à des agents pathogènes. L'un des points forts de la norme est sa capacité à définir précisément la terminologie utilisée dans le contexte des risques microbiologiques, ce qui facilite la compréhension et l'application des directives par les fabricants et les utilisateurs. En harmonisant le langage autour des exigences de performance, la norme améliore la communication et la conformité au sein de l'industrie. De plus, la SIST EN ISO 374-5:2017 est d'une grande pertinence dans le cadre sanitaire actuel, où la protection contre les micro-organismes est plus cruciale que jamais. En garantissant que les gants répondent à des critères rigoureux de sécurité, cette norme contribue à minimiser les risques de contamination dans des environnements tels que les hôpitaux, les laboratoires et d'autres secteurs sensibles. Il est également important de noter que la norme SIST EN ISO 374-5:2017 ne se limite pas aux seuls risques microbiologiques. Elle souligne la nécessité d'évaluer d'autres caractéristiques de protection, telles que les risques chimiques, mécaniques, thermiques et la dissipation électrostatique, en utilisant les normes spécifiques appropriées. Cela démontre la volonté de la norme de s'inscrire dans un cadre de protection global adaptable aux différents besoins des utilisateurs. En somme, la norme SIST EN ISO 374-5:2017 se positionne comme un outil fondamental pour garantir la sécurité des utilisateurs de gants protecteurs contre les micro-organismes, tout en offrant une base solide pour l'intégration de mesures de protection supplémentaires lorsque cela est nécessaire.
SIST EN ISO 374-5:2017は、危険な化学物質および微生物に対する保護手袋に関する重要な国際規格です。この規格は、微生物のリスクから使用者を保護するために設計された保護手袋の要件と試験方法を明確に定義しています。 この標準の大きな強みは、その包括的な用語集と性能要件にあります。保護手袋がどのように微生物に対して機能するのかを詳細に説明しており、製品開発者やユーザーにとって非常に有益です。また、試験方法に関しても明確に記載されており、実際の使用環境での効果を科学的に検証することが可能です。 さらに、SIST EN ISO 374-5:2017は、保護手袋に関する他の特定の性能基準と組み合わせて使用することで、より広範なリスク管理が可能になる点も注目すべきです。例えば、化学リスク、機械的リスク、熱リスク、静電気放散など、必要に応じて適切な基準を組み合わせることが推奨されています。これにより、製品が多様なリスクに対応できるような設計が促進されます。 総じて、SIST EN ISO 374-5:2017は、微生物リスクからの保護を求めるすべての業界にとって、信頼性の高い指針を提供するものであり、保護手袋の安全性と有効性を確保するための重要な資源です。
SIST EN ISO 374-5:2017 표준은 미생물 위험으로부터 사용자를 보호하기 위한 보호 장갑에 대한 요구 사항 및 시험 방법을 규정하고 있습니다. 이 표준은 사용자의 안전을 최우선으로 고려하여 미생물로 인한 위험을 최소화하기 위한 성능 요건을 상세히 명시합니다. 이 표준의 강점은 그 명확한 용어 정의와 성능 기준 설정입니다. 이는 사용자가 보호 장갑을 선택할 때 올바른 정보를 제공하여, 특정 환경에서의 미생물 공격으로부터 효율적으로 보호할 수 있도록 돕습니다. 특히, 이 표준은 화학적 위험, 기계적 위험, 열적 위험, 정전기 배출과 같은 다른 보호 특성이 필요한 경우, 적절한 특정 성능 표준을 추가로 활용해야 한다는 점을 강조합니다. 이는 사용자가 다양한 위험 요소에 대응할 수 있도록 도와줍니다. SIST EN ISO 374-5:2017의 적합성과 중요성은 현재와 미래의 근무 환경에서 미생물로부터의 위험이 지속적으로 증가하고 있는 상황에서 더욱 강조됩니다. 따라서, 이 표준을 준수하는 보호 장갑은 개인의 건강을 지키고, 감염 예방에 중요한 역할을 할 수 있습니다. 따라서, 이 표준은 보호 장갑의 성능과 안전성을 보장하기 위한 필수적인 기준으로 자리 잡고 있습니다.
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