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EN 285:2006+A2:2009 Standard

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  Keywords:

#loads #metal #european #test #medical

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sterilization - Steam sterilizers - Large sterilizers

  Purpose

his European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 285:2006"

  Related Standards

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EN ISO 10993-11:2009

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EN ISO 10993-9:2009

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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN ISO 10993-7:2008/AC:2009

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

EN ISO 10993-7:2008

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

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