Sterilization and disinfection

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 ISO 11737-2:2009
Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process

BS EN ISO 11737-1:2006
Sterilization of medical devices. Microbiological methods. Determination of a population of microorganisms on products

BS EN ISO 14161:2009
Clinical investigation of medical devices for human subjects. General requirements

BS EN 285:2006+Amendment 2 2009
Sterilization. Steam sterilizers. Large sterilizers

BS EN ISO 15883-1:2006
Washer-disinfectors. General requirements, terms and definitions and tests

BS EN ISO 15883-2:2006
Washer-disinfectors. Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

BS EN ISO 15883-4:2008
Washer-disinfectors. Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

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

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

PAS 5748:2011
Cleanliness in healthcare facilities. Hospitals. Specification
Read more about the new standard for hospital cleanlinessReturn to the healthcare and medical devices homepage

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