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EN 14180:2003 +A2:2009 Standard

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  Keywords:

#sterilization #european #sterilizing #requirements #standard

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

  Purpose

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

  Publication

Friday 17th of November 2017

  Amendment

This standard is an amendment for "EN 14180:2003"

  Reference

This standard superseed the "EN 14180:2003 +A1:2009".

Anyway is still possible use the "EN 14180:2003 +A1:2009" until March 21st, 2010

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