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.
BS EN 14180 on low temperature steam and formaldehyde sterilizers is useful for:
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.
BS EN 14180:2014 supersedes EN 14180:2003+A2:2009, which is withdrawn.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:
EN 14180:2014