SIST EN 455-2:2015
(Main)Medical gloves for single use - Part 2: Requirements and testing for physical properties
Medical gloves for single use - Part 2: Requirements and testing for physical properties
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 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.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften
Diese Norm legt Anforderungen und Prüfmethoden der physikalischen Eigenschaften medizinischer Hand-schuhe zum einmaligen Gebrauch (d. h. Operationshandschuhe und Untersuchungs-/Behandlungshandschuhe) fest, um sicherzustellen, dass bei Gebrauch ausreichender Schutz vor Kontamination für Patient und Anwender gewährleistet und aufrechterhalten wird.
Diese Norm legt keine Chargengröße fest. Es wird auf die Schwierigkeiten verwiesen, die mit der Verteilung und Kontrolle sehr großer Chargen verbunden sein können. Die empfohlene maximale Einzelchargengröße für die Herstellung beträgt 500 000.
Gants médicaux non réutilisables - Partie 2: Propriétés physiques: exigences et essais
La présente Norme européenne spécifie les exigences et méthodes d'essai relatives aux propriétés physiques des gants médicaux non réutilisables (c'est-à-dire des gants de chirurgie et des gants d'examen et de soins), afin de garantir qu'ils assurent et conservent pendant toute la durée de leur utilisation un niveau de protection suffisant contre toute contamination croisée, à la fois pour le patient et pour l'utilisateur.
La présente Norme ne spécifie pas la taille du lot. L’attention est attirée sur les difficultés pouvant être liées à la distribution et à la vérification de lots de volume très important. La taille maximale recommandée d’un lot de production est de 500 000 unités.
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnosti
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnostiMedizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen EigenschaftenGants médicaux non réutilisables - Partie 2: Propriétés physiques: exigences et essaisMedical gloves for single use - Part 2: Requirements and testing for physical properties11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 455-2:2015SIST EN 455-2:2015en,fr,de01-julij-2015SIST EN 455-2:2015SLOVENSKI
STANDARDSIST EN 455-2:2010+A2:20131DGRPHãþD
SIST EN 455-2:2015
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2
April 2015 ICS 11.140 Supersedes EN 455-2:2009+A2:2013English Version
Medical gloves for single use - Part 2: Requirements and testing for physical properties
Gants médicaux non réutilisables - Partie 2 : Exigences et essais pour propriétés physiques
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 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 worldwide for CEN national Members. Ref. No. EN 455-2:2015 ESIST EN 455-2:2015
EN 455-2:2015 (E) 2 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
SIST EN 455-2:2015
EN 455-2:2015 (E) 3 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. SIST EN 455-2:2015
EN 455-2:2015 (E) 4 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
...
SLOVENSKI STANDARD
oSIST prEN 455-2:2013
01-september-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: prEN 455-2
ICS:
11.140 Oprema bolnišnic Hospital equipment
oSIST prEN 455-2:2013 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 455-2:2013
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oSIST prEN 455-2:2013
EUROPEAN STANDARD
DRAFT
prEN 455-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2013
ICS 11.140 Will supersede 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: Propriétés Medizinische Handschuhe zum einmaligen Gebrauch - Teil
physiques: exigences et essais 2: Anforderungen und Prüfung der physikalischen
Eigenschaften
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, 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.
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
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 455-2:2013: E
worldwide for CEN national Members.
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oSIST prEN 455-2:2013
prEN 455-2:2013 (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 .6
5.1 General .6
5.2 Force at break .6
5.3 Force at break after challenge testing .7
6 Test report .7
7 Labelling .8
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC concerning medical devices . 10
2
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oSIST prEN 455-2:2013
prEN 455-2:2013 (E)
Foreword
This document (prEN 455-2:2013) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede 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) new clause for labelling requirements included;
b) normative references revised;
c) new clause 7 "labelling" introduced;
d) exception for nitrile in Table 3 for median values of force of break deleted;
e) 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
3
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oSIST prEN 455-2:2013
prEN 455-2:2013 (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 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 ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information
to be supplied - Part 1: General requirements
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 laying 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 materials of the same specifications, common equipment and
packed in the same type of individual container
[SOURCE: EN 455-4:2009]
4
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oSIST prEN 455-2:2013
prEN 455-2:2013 (E)
4 Dimensions
4.1 General
When measured as described in 4.2 and 4.3 taking 13 samples
...
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