DIN EN 14180:2010
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009

Standard No.
DIN EN 14180:2010
Release Date
2010
Published By
German Institute for Standardization
Status
Replace By
DIN EN 14180:2014
DIN EN 14180 E:2012-06
Latest
DIN EN 14180:2023-04
Replace
DIN EN 14180:2003 DIN EN 14180/A2:2009 DIN EN 14180/A1:2009
Scope
This 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 sterilization of heat labile medical devices in health care facilities.

DIN EN 14180:2010 Referenced Document

  • EN 60584-2 Thermocouples Part 2: Tolerances (Remains Current)
  • EN 60751 Industrial platinum resistance thermometers and platinum temperature sensors
  • EN 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*2019-04-26 Update
  • EN 61326:1997 Electrical Equipment for Measurement@ Control and Laboratory Use - EMC Requirements (Incorporates Amendments A1: 1998@ A2: 2001 and A3: 2003)
  • EN 867-5 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers type B and type S
  • EN 868-5 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods*2018-12-01 Update
  • EN ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements*2017-03-01 Update
  • EN ISO 11138-5 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes*2017-03-01 Update
  • EN ISO 3746 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)*2024-04-19 Update
  • ISO 228-1 Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation

DIN EN 14180:2010 history

  • 2023 DIN EN 14180:2023-04 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023 / Note: Date of issue 2023-03-24*Intended as replacement for DIN EN 14180 (2014-09).
  • 2023 DIN EN 14180:2023 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023
  • 2014 DIN EN 14180:2014-09 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
  • 2014 DIN EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2014
  • 2010 DIN EN 14180:2010 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009
  • 0000 DIN EN 14180/A1:2009
  • 0000 DIN EN 14180:2003
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German version EN 14180:2003+A2:2009



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