What is BS EN 14180 - Low temperature steam and formaldehyde sterilizers about?
BS EN 14180 is a European standard on sterilizers for medical purposes that discusses requirements and testing for low temperature and formaldehyde sterilizers to ensure sterilizing of medical devices.
BS EN 14180 outlines the requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agents, and which are working below ambient pressure only and ensures proper routine control of sterilization processes.
These sterilizers are primarily used for the sterilization of heat-labile medical devices in health care facilities.
Who is BS EN 14180 - Low temperature steam and formaldehyde sterilizers for?
BS EN 14180 on low temperature steam and formaldehyde sterilizers is useful for:
- Low temperature steam and formaldehyde sterilizers manufacturers
- Test centres
- Regulatory authorities
Why should you use BS EN 14180 - Low temperature steam and formaldehyde sterilizers?
Low temperature steam and formaldehyde sterilizers are primarily used for the sterilization of medical devices in health care facilities but can also be used during the commercial production of medical devices.
BS EN 14180 guideline assists you with the technical requirements, process control, performance requirements, sound power, vibration, service, and local environment for low temperature steam and formaldehyde sterilizers.
BS EN 14180 provides you with minimum requirements for the performance and design of sterilizers that assists in knowing that the process is capable of sterilizing medical devices. BS EN 14180 also provides you with the minimum requirements for the equipment and control of sterilizers that assist in the validation and routine control of the sterilization processes.
With compliance and obedience to BS EN 14180, you can enhance the efficacy of low temperature and formaldehyde sterilizers for use in the sterilization of medical devices.
What’s changed since the last update?
BS EN 14180:2014 supersedes EN 14180:2003+A2:2009, which is withdrawn. BS EN 14180:2014 has made some technical changes compared to EN 14180:2003+A2:2009. These includes:
- Normative references were updated
- Terms risk assessment, risk analysis, and software validation were added
- Align biological testing with method from EN ISO 25424
- Requirements for heat isolation were updated
- Safety requirements, mainly because of compliance with the machinery directive were added
