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CEN

EN 455-1:2020

(Main)

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1: Anforderungen und Prüfung auf Dichtheit

Dieses Dokument legt Anforderungen und Prüfung auf Dichtheit von medizinischen Handschuhen zum einmaligen Gebrauch fest.

Gants médicaux non réutilisables - Partie1 : Exigences et essais pour la détection de l'absence de trous

Le présent document spécifie des exigences et indique la méthode d’essai permettant de déterminer l'absence de trous dans les gants médicaux non réutilisables.

Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za ugotavljanje odsotnosti lukenj

General Information

Status
Withdrawn
Publication Date
12-May-2020
Withdrawal Date
22-Feb-2022
ICS
11.140 - Hospital equipment
Technical Committee
CEN/TC 205 - Non-active medical devices
Drafting Committee
CEN/TC 205/WG 3 - Medical gloves
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
23-Feb-2022
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 455-1:2020 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

Relations

Replaces
EN 455-1:2000 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Effective Date
15-Jul-2018
Merged Into
EN 455-1:2020+A1:2022 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Effective Date
18-Jan-2023
Amended By
EN 455-1:2020/prA1 - Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Effective Date
05-May-2021

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 455-1:2020
01-september-2020
Nadomešča:
SIST EN 455-1:2001
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
Medizinische Handschuhe zum einmaligen Gebrauch - Anforderungen und Prüfung auf
Dichtheit
Gants médicaux non réutilisables - Partie1 : Exigences et essais pour la détection de
l'absence de trous
Ta slovenski standard je istoveten z: EN 455-1:2020
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455-1:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 455-1:2020

---------------------- Page: 2 ----------------------
SIST EN 455-1:2020


EN 455-1
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2020
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-1:2000
English Version

Medical gloves for single use - Part 1: Requirements and
testing for freedom from holes
Gants médicaux non réutilisables - Partie1 : Exigences Medizinische Handschuhe zum einmaligen Gebrauch -
et essais pour la détection de l'absence de trous Teil 1: Anforderungen und Prüfung auf Dichtheit
This European Standard was approved by CEN on 13 April 2020.

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, Turkey 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-1:2020 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
SIST EN 455-1:2020
EN 455-1:2020 (E)
Contents Page
European foreword . 3
1 Scope . 4
2 Normative references . 4
3 Terms and definitions . 4
4 Requirement . 4
5 Water tightness test for detection of holes . 4
5.1 Referee testing . 4
5.2 Routine testing . 5
6 Sampling, inspection level and AQL. 5
7 Test report . 5
Annex A (informative) Guidance on relationship between this European Standard and the
General Safety and Performance Requirements of Regulation (EU)
2017/745 [OJ L 117] aimed to be covered . 7
Bibliography . 8

2

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...

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