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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)

  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

Friday 17th of November 2017

  Amendment

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

  Reference

This standard supersedes the "EN 285:2006 +A1:2008"

Anyway is still possible use the "EN 285:2006 +A1:2008" until March 21st, 2010

  Related Standards

EN ISO 13485:2016/AC:2016

Medical devices Directive (93/42/EEC)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 10651-2:2009

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Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

EN ISO 10993-12:2012

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

EN ISO 10993-11:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

EN ISO 10993-9:2009

Medical devices Directive (93/42/EEC)

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

EN ISO 10993-7:2008/AC:2009

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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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 285:2006/A2:2009 STANDARD

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