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EN 455-2:2009 +A2:2013 Standard

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  Keywords:

#size #lot #attention #associated #drawn

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 455-2:2009"

  Reference

This standard superseed the "EN 455-2:2009 +A1:2011".

Anyway is still possible use the "EN 455-2:2009 +A1:2011" until October 31st, 2014

  Related Standards

EN 455-4:2009

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EN 60601-1-6:2010

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EN ISO 81060-1:2012

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EN 27740:1992/AC:1996

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Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 27740:1992/A1:1997

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Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 1422:1997 +A1:2009

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Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

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