SIST EN 455-1:2020+A2:2024

SLOVENSKI STANDARD
01-december-2024
Medicinske rokavice za enkratno uporabo - 1. del: Zahteve in preskusi za
ugotavljanje odsotnosti lukenj (vključno z dopolnilom A2)
Medical gloves for single use - Part 1: Requirements and testing for freedom of holes
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 1: Anforderungen und
Prüfung auf Dichtheit
Gants médicaux non réutilisables - Partie 1 : Exigences et essais pour la détection de
l'absence de trous
Ta slovenski standard je istoveten z: EN 455-1:2020+A2:2024
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 455-1:2020+A2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 11.140 Supersedes EN 455-1:2020+A1:2022
English Version
Medical gloves for single use - Part 1: Requirements and
testing for freedom of holes
Gants médicaux non réutilisables - Partie 1 : 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 16 December 2021 and includes Amendment 2 approved by CEN on 12 August
2024.
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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-1:2020+A2:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Requirement . 5
5 Water tightness test for detection of holes . 6
5.1 Referee testing . 6
5.2 Routine testing . 6
6 Sampling, inspection level and AQL. 6
7 Test report . 6
Annex ZA (informative) #Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered$ . 8

European foreword
This document (EN 455-1:2020+A2:2024) 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 March 2025, and conflicting national standards shall
be withdrawn at the latest by March 2025.
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 455-1:2020+A1:2022$.
This document includes Amendment 1 approved by CEN on 23 February 2022 and Amendment 2
approved by CEN on 12 August 2024.
The start and finish of text introduced or altered by amendment is indicated in the text by tags !"
and #$.
In comparison with the previous 2000 edition, the following main changes have been introduced to the
2020 edition:
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.
This document has been prepared under a standardisation request addressed to CEN and CENELEC by
the European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
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.
A list of all parts in a series can be found on the CEN website.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
1 Scope
This document specifies requirements and gives the test method for medical gloves for single use in
order to determine freedom from holes.
2 Normative references
#The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (inc
...