If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:
There is a growing concern over hospital acquired infection; bacteria and viruses can be carried from person to person on the surface of any medical equipment unless it is decontaminated between use. Sterilisation and disinfection reduces the risks of cross infection (the process by which microbes are passed from one infected person, to cause infection in another).
BSI's European and international standards give recommendations on the sterilization of healthcare products, and testing of chemical disinfectants and antiseptics.
BS EN 285 is an amended European Standard that specifies the requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules.
 BS EN 15424:2007
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
BS EN ISO 11135-1:2007
Sterilization of health care products. Ethylene oxide, Requirements for development, validation and routine control of a sterilization process for medical devices |
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BS EN 14885:2006
Chemical disinfectants and antiseptics. Application of European Standards for chemical disinfectants and antiseptics |
BS EN ISO 11137-2 : 2007
Sterilization of health care products. Radiation. Establishing the sterilization dose |
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