EN 455-2:2009+A2:2013
(Main + Amendment)Medical gloves for single use - Part 2: Requirements and testing for physical properties
General Information
- Abstract
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.
- Status
- Withdrawn
- Publication Date
- 05-Feb-2013
- Withdrawal Date
- 22-Sep-2026
- Technical Committee
- CEN/TC 205 - Non-active medical devices
- Drafting Committee
- CEN/TC 205/WG 3 - Medical gloves
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 29-Apr-2015
- Completion Date
- 23-Sep-2026
- Directive
- Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 149 OJ Date: 16-May-2014
Relations
- Effective Date
- 18-Jan-2023
- Effective Date
- 06-May-2015
- Effective Date
- 25-Aug-2026
- Refers
ISO 188:2007 - Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests - Effective Date
- 25-Aug-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 455-2:2009+A2:2013 is a standard published by the European Committee for Standardization (CEN). Its full title is "Medical gloves for single use - Part 2: Requirements and testing for physical properties". This standard covers: 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.
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.
EN 455-2:2009+A2:2013 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 455-2:2009+A2:2013 has the following relationships with other standards: It is inter standard links to EN 455-2:2009+A1:2011, EN 455-2:2015, ISO 23529:2004, ISO 188:2007, EN 13171:2012/FprA1, EN 4159:2011, EN 62541-3:2015, CEN ISO/TS 14823:2008, EN ISO 11616:2012, EN 1789:2007+A2:2014, EN ISO 14816:2005, EN ISO 11615:2012, CEN ISO/TS 19139:2009, EN ISO 21549-6:2008, CEN ISO/TS 18234-7:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 455-2:2009+A2:2013 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 455-2:2009+A2:2013 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische 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 455-2:2009+A2:2013SIST EN 455-2:2010+A2:2013en,fr,de01-maj-2013SIST EN 455-2:2010+A2:2013SLOVENSKI
STANDARDSIST EN 455-2:2010+A1:20111DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 455-2:2009+A2
February 2013 ICS 11.140 Supersedes EN 455-2:2009+A1:2011
English 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 and includes Amendment 1 approved by CEN on 3 January 2011 and Amendment 2 approved by CEN on 8 January 2013.
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
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 455-2:2009+A2:2013: E SIST EN 455-2:2010+A2:2013
#Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning Medical Devices$ . 11
[EN 455-4:2009] SIST EN 455-2:
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