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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

Wednesday 25th of March 2020

  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 27740:1992/A1:1997

Medical devices Directive (93/42/EEC)

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

EN 27740:1992/AC:1996

Medical devices Directive (93/42/EEC)

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

EN 1820:2005 +A1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

EN ISO 5840:2009

Medical devices Directive (93/42/EEC)

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

EN 13060:2014

Medical devices Directive (93/42/EEC)

Small steam sterilizers

EN ISO 13408-2:2011

Medical devices Directive (93/42/EEC)

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

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