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SIST EN 455-3:2024

(Main)

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for
single use. It gives requirements for labelling and the disclosure of information relevant to the test
methods used.

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische Bewertung

Dieser Teil von EN 455 legt Anforderungen für die Bewertung der biologischen Sicherheit von medizinischen Handschuhen zum einmaligen Gebrauch fest. Er enthält Anforderungen an die Kennzeichnung und die Informationsangaben entsprechend den angewendeten Prüfverfahren.
ANMERKUNG   Medizinische Handschuhe, die für den einmaligen Gebrauch gekennzeichnet sind, sind Medizinprodukte für den einmaligen Gebrauch nach der Verordnung (EU) 2017/745. Ein Medizinprodukt zum einmaligen Gebrauch bezieht sich auf ein Produkt, das für die Verwendung an einer einzigen Person an einem einzigen Tag vorgesehen ist.

Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation biologique

La présente partie de l’EN 455 spécifie les exigences permettant d’évaluer la sécurité biologique des gants médicaux non réutilisables. Elle mentionne les exigences d’étiquetage des gants et de diffusion des informations concernant les méthodes d’essai utilisées.
NOTE   Conformément au règlement (UE) 2017/745, les gants médicaux étiquetés non réutilisables sont des dispositifs médicaux à usage unique. Un dispositif médical à usage unique désigne un dispositif conçu pour être utilisé sur une personne physique au cours d’une procédure unique.

Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za biološko ovrednotenje

Ta del standarda EN 455 določa zahteve za ovrednotenje biološke varnosti medicinskih rokavic za
enkratno uporabo. Določa zahteve za označevanje in razkrivanje informacij, ki so pomembne za uporabljene preskusne metode.

General Information

Status
Published
Public Enquiry End Date
17-May-2022
Publication Date
08-Feb-2024
ICS
11.140 - Hospital equipment
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
24-Jan-2024
Due Date
30-Mar-2024
Completion Date
09-Feb-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
EN 455-3:2023 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

Relations

Replaces
SIST EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
01-Mar-2024

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SLOVENSKI STANDARD
SIST EN 455-3:2024
01-marec-2024
Nadomešča:
SIST EN 455-3:2015
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskušanje za
biološko ovrednotenje
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und
Prüfung für die biologische Bewertung
Gants médicaux non réutilisables - Partie 3 : Exigences et essais pour évaluation
biologique
Ta slovenski standard je istoveten z: EN 455-3:2023
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455-3:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 455-3:2024

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SIST EN 455-3:2024


EN 455-3
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2023
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-3:2015
English Version

Medical gloves for single use - Part 3: Requirements and
testing for biological evaluation
Gants médicaux non réutilisables - Partie 3 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour évaluation biologique Teil 3: Anforderungen und Prüfung für die biologische
Bewertung
This European Standard was approved by CEN on 29 October 2023.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-3:2023 E
worldwide for CEN national Members.

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SIST EN 455-3:2024
EN 455-3:2023 (E)
Contents Page
European foreword . 5
Introduction . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Requirements . 9
4.1 General . 9
4.2 Chemicals . 9
4.3 Endotoxins . 10
4.4 Powder-free gloves . 10
4.5 Proteins, leachable . 10
4.6 Labelling . 10
5 Test methods .
...

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