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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)

  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 supersedes the "EN 14180:2003 +A1:2009"

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

  Related Standards

EN 12470-2:2000+A1:2009

Medical devices Directive (93/42/EEC)

Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers

EN 80601-2-35:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating device...

EN 60645-1:2001

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometersIEC 60645-1:2001

EN 60645-2:1997

Medical devices Directive (93/42/EEC)

Audiometers - Part 2: Equipment for speech audiometryIEC 60645-2:1993

EN 60645-3:2007

Medical devices Directive (93/42/EEC)

Electroacoustics - Audiometric equipment - Part 3: Test signals of short durationIEC 60645-3:2007

EN 60645-4:1995

Medical devices Directive (93/42/EEC)

Audiometers - Part 4: Equipment for extended high-frequency audiometryIEC 60645-4:1994

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