EN 455-1:2020

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

European foreword
This document (EN 455-1:2020) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices”, the secretariat of which is held by DIN.
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 November 2020, and conflicting national standards
shall be withdrawn at the latest by November 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 455-1:2000.
Compared to the previous edition the following main changes have been introduced:
a) The term 3.1 “medical gloves for single-use” has been amended by a Note to entry;
b) The term 3.2 “hole” has been added;
c) In 5.1 the referee testing has been enhanced to cover the issue on extension of the glove when it is
filled with water;
d) In Clause 6 the first paragraph has been slightly changed to accommodate the EU commission rules
for referencing ISO standards which are not available as EN standards;
e) Due to that there is currently no standardization request by the EU commission for this part of
EN 455 the harmonization process to provide presumption of conformity to the Medical Device
Regulation (MDR) cannot be applied. However, to provide at least guidance on the relationship
between this European Standard and the General Safety and Performance Requirements of
Regulation (EU) 2017/745 [OJ L 117] aimed to be covered, an Annex A has been added.
EN 455 consists of the following parts under the general title “Medical gloves for single use”:
— Part 1: Requirements and testing for freedom from holes;
— Part 2: Requirements and testing for physical properties;
— Part 3: Requirements and testing for biological evaluation;
— Part 4: Requirements and testing for shelf life determination.
The following part is under development:
— Part 5: Extractable chemical residues.
According to the CEN-CENELEC Internal Regulations, the national standards
...