EN 455-2:2009/FprA1

Medical gloves for single use - Part 2: Requirements and testing for physical properties

This Amendment provides an updated Table 3 "The median values of force at break" to minimize the possible interpretation and misunderstandings regarding the values given in the appropriate table of EN 455-2:2009.
Scope of the mother text:
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

Gants médicaux non réutilisables - Partie 2: Propriétés physiques: Exigences et essais

Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za ugotavljanje fizikalnih lastnosti - Dopolnilo

General Information

• Status: Not Published
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 3 - Medical gloves
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 02-Dec-2010
• Due Date: 19-Dec-2011
• Completion Date: 02-Dec-2010
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 455-2:2010/kFprA1:2010 - Medical gloves for single use - Part 2: Requirements and testing for physical properties

Relations

• Merged Into: EN 455-2:2009+A1:2011 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 19-Jan-2023
• Amends: EN 455-2:2009 - Medical gloves for single use - Part 2: Requirements and testing for physical properties
• Effective Date: 12-Jun-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 455-2:2010/kFprA1:2010
01-november-2010
Medicinske rokavice za enkratno uporabo - 2. del: Zahteve in preskusi za
ugotavljanje fizikalnih lastnosti - Dopolnilo
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 455-2:2009/FprA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 455-2:2010/kFprA1:2010 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 455-2:2010/kFprA1:2010

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SIST EN 455-2:2010/kFprA1:2010


EUROPEAN STANDARD
FINAL DRAFT
EN 455-2:2009
NORME EUROPÉENNE

EUROPÄISCHE NORM
FprA1
September 2010
ICS 11.140
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 amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 205.

This draft amendment A1, if approved, will modify the European Standard EN 455-2:2009. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.

This draft amendment 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, Croatia, 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
...