Need help?

EN 455-2:2009/A2:2013 Standard

wave
Save  

  Keywords:

#size #lot #attention #associated #drawn

  Directive

Medical devices Directive (93/42/EEC)

  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 supersedes 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 13795-2:2019

Medical devices Directive (93/42/EEC)

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

EN ISO 81060-1:2012

Medical devices Directive (93/42/EEC)

Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)

EN ISO 11990:2018

Medical devices Directive (93/42/EEC)

Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)

EN ISO 25424:2019

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

EN 1820:2005+A1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

EN 1422:1997+A1:2009

Medical devices Directive (93/42/EEC)

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

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN 455-2:2009/A2:2013 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0