SIST EN 455-2:2015

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SLOVENSKI STANDARD
01-julij-2015
1DGRPHãþD
SIST EN 455-2:2010+A2:2013
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za
ugotavljanje fizikalnih lastnosti
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und
Prüfung der physikalischen Eigenschaften
Gants médicaux non réutilisables - Partie 2: Propriétés physiques: exigences et essais
Ta slovenski standard je istoveten z: EN 455-2:2015
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10

EUROPEAN STANDARD
EN 455-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2015
ICS 11.140 Supersedes EN 455-2:2009+A2:2013
English Version
Medical gloves for single use - Part 2: Requirements and testing
for physical properties
Gants médicaux non réutilisables - Partie 2 : Exigences et Medizinische Handschuhe zum einmaligen Gebrauch - Teil
essais pour propriétés physiques 2: Anforderungen und Prüfung der physikalischen
Eigenschaften
This European Standard was approved by CEN on 24 January 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-2:2015 E
worldwide for CEN national Members.

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 455-2:2015 (E)
Contents Page
Foreword .3
1 Scope .4
2 Normative references .4
3 Terms and definitions .4
4 Dimensions .5
4.1 General .5
4.2 Length .5
4.3 Width .5
5 Strength .7
5.1 General .7
5.2 Force at break .7
5.3 Force at break after challenge testing .9
6 Test report . 10
7 Labelling . 10
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC concerning medical devices . 11

Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
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EN 455-2:2015 (E)
Foreword
This document (EN 455-2:2015) 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 October 2015 and conflicting national standards shall be withdrawn at
the latest by October 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 455-2:2009+A2:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this document.
With respect to EN 455-2:2009+A2:2013 the following changes are:
a) normative references revised;
b) new Clause 7 "labelling" introduced;
c) exception for nitrile in Table 3 for median values of force of break deleted;
d) Annex ZA updated.
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
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Posebna objava SIST z dovoljenjem CEN, CENELEC, ISO in IEC: Za potrebe zagotavljanja brezplačnega dostopa do vsebin standardov v času epidemije COVID-19.
Samo za branje. Kopiranje in posredovanje prepovedano. © SIST 2020-04-10
EN 455-2:2015 (E)
1 Scope
This European Standard specifies requirements and gives test methods for physical properties of single-use
medical gloves (i.e. surgical gloves and examination/procedure gloves) in order to ensure that they provide
and maintain in use an adequate level of protection from cross contamination for both patient and user.
This European Standard does not specify the size of a lot. Attention is drawn to the difficulties that can be
associated with the distribution and control of very large lots. The recommended maximum individual lot size
for production is 500 000.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
EN 455-4:2009, Medical gloves for single use — Part 4: Requirements and testing for shelf life determination
EN 1041:2008+A1:2013, Information supplied by the manufacturer of medical devices
EN ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied —Part 1: General requirements (ISO 15223-1:2012)
ISO 188:2007, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 23529:2010, Rubber — General procedures for preparing and conditioning test pieces for physical test
methods
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
medical gloves for single use
gloves intended for use in the medical field to protect patient and user from cross-contamination
3.2
surgical gloves
sterile, anatomically shaped medical gloves with the thumb positioned towards the palmar surface of the index
finger rather than lying flat, and intended for use in invasive surgery
3.3
examination gloves
procedure gloves
sterile or non-sterile medical gloves, which may or may not be anatomically shaped, intended for conducting
medical examinations, diagnostic and therapeutic procedures and for handling contaminated medical material
3.4
lot
collection of gloves of the same design, colour, shape, size and formulation, manufactured at essentially the
same time, using the same process, raw materia
...