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kSIST FprEN 455-3:2023

(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.
NOTE   Medical gloves labelled as single use are medical devices for single use only according to the Regulation (EU) 2017/745. A single use medical device means a device that is intended to be used on one individual during a single procedure.

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

General Information

Status
Not Published
Public Enquiry End Date
17-May-2022
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
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

Revised
SIST EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
19-Jan-2023
Revised
SIST EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
18-Jan-2023
Revised
SIST EN 455-3:2015 - Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Effective Date
18-Dec-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 455-3:2022
01-maj-2022
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: prEN 455-3
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN 455-3:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 455-3:2022

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oSIST prEN 455-3:2022


DRAFT
EUROPEAN STANDARD
prEN 455-3
NORME EUROPÉENNE

EUROPÄISCHE NORM

February 2022
ICS 11.140 Will supersede 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 draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 205.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Turkey and
United Kingdom.

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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 455-3:2022 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 455-3:2022
prEN 455-3:2022 (E)
Contents Page
European foreword . 5
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 Requirements . 8
4.1 General . 8
4.2 Chemicals . 8
4.3 Endotoxins . 8
4.4 Powder-free gloves . 9
4.5 Proteins, leachable .
...

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