SIST EN 455-2:2010
(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 standard specifies requirements and gives test methods for physical properties of single-use medical gloves in order to ensure and maintain in use an adequate level of protection from cross contamination for both patient and user.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften
Diese Norm legt Anforderungen und Prüfmethoden der physikalischen Eigenschaften medizinischer Handschuhe zum einmaligen Gebrauch (d. h. Operationshandschuhe und Untersuchungshandschuhe) fest, um sicherzustellen, dass bei Gebrauch ausreichender Schutz vor Kontamination für Patient und Anwender gewährleistet und aufrechterhalten wird.
Gants médicaux non réutilisables - Partie 2 : Propriétés physiques : Exigences et essais
La présente partie de la présente Norme 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
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnosti
Ta evropski standard določa zahteve in podaja preskusne metode za ugotavljanje fizikalnih lastnosti medicinskih rokavic za enkratno uporabo (tj. kirurških rokavic ter rokavic za preglede/postopke), ki zagotavljajo, da rokavice omogočajo in med uporabo ohranjajo primerno raven zaščite bolnika in uporabnika pred navzkrižno okužbo. Ta standard ne določa velikosti lota. Upoštevati je treba težave, ki so lahko povezane z dostavo in nadzorom zelo velikih lotov. Največja priporočena velikost posameznega lota za proizvodnjo je 500.000.
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 455-2:2009SIST EN 455-2:2010en,fr,de01-januar-2010SIST EN 455-2:2010SLOVENSKI
STANDARDSIST EN 455-2:20011DGRPHãþD
SIST EN 455-2:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2
November 2009 ICS 11.140 Supersedes EN 455-2:2000English Version
Medical gloves for single use -Part 2: Requirements and testing for physical properties
Gants médicaux non réutilisables - Partie 2 : Propriétés physiques: exigences et essais
Medizinische Handschuhe zum einmaligen Gebrauch -Teil 2: Anforderungen und Prüfung der physikalischen Eigenschaften This European Standard was approved by CEN on 3 October 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2009: ESIST EN 455-2:2010
EN 455-2:2009 (E) 2 Contents Page Foreword . 31 Scope . 42 Normative references . 43 Terms and definitions . 44 Dimensions . 54.1 General. 54.2 Length . 54.3 Width . 55 Strength . 65.1 General. 65.2 Force at break . 65.3 Force at break after challenge testing . 76 Test Report . 8Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning medical devices . 10 SIST EN 455-2:2010
EN 455-2:2009 (E) 3 Foreword This document (EN 455-2:2009) 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 May 2010, and conflicting national standards shall be withdrawn at the latest by May 2010. 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 455-2:2000. 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. 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
SIST EN 455-2:2010
EN 455-2:2009 (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 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 referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests ISO 23529:2004, 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
[EN 455-4:2009] SIST EN 455-2:2010
EN 455-2:2009 (E) 5 4 Dimensions 4.1 General When measured as described in 4.2 and 4.3 taking 13 samples from each lot, the median value obtained for the dimensions shall be as given
...
SLOVENSKI STANDARD
oSIST prEN 455-2:2008
01-julij-2008
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 455-2:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
DRAFT
prEN 455-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2008
ICS 11.140 Will supersede EN 455-2:2000
English Version
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
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 Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland 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.
: This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
Warning
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 455-2:2008: E
worldwide for CEN national Members.
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prEN 455-2:2008 (E)
Contents Page
Foreword.2
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
6 Test Report.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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prEN 455-2:2008 (E)
Foreword
This document (prEN 455-2:2008) 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 455-2:2000.
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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
3
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prEN 455-2:2008 (E)
1 Scope
This Part of this 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
ISO 4648, Rubber, vulcanized or thermoplastic — Determination of dimensions of test pieces and products for
test purposes
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/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
a 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
1
packed in the same type of individual container )
(see pr EN 455-4:2007)
1
) 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.
4
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prEN 455-2:2008 (E)
4 Dimensions
4.1 General
...
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