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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 9170-1:2008

Medical devices Directive (93/42/EEC)

Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 917...

EN ISO 10993-6:2009

Medical devices Directive (93/42/EEC)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

EN ISO 15883-4:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endo...

EN ISO 15883-3:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste contai...

EN ISO 15883-2:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instrumen...

EN ISO 15883-1:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)

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