The Principles of Medical Device Decontamination

Terminology and Definitions

A form of protein thought to be the causative agent of transmissible spongiform encephalopathies [TSEs] e.g. Creutzfeldt-Jakob disease [CJD]. The protein is remarkably resistant to conventional methods of disinfection and sterilisation. Transfer of sterile contents from its sterile barrier system using conditions and procedures that minimize the risk of microbial contamination

Abnormal protein

Aseptic technique

Population of viable microorganisms on or in a product and/or sterile barrier system

Bioburden

A chemical agent, which under defined conditions is capable of killing bacteria.

Biocide

Test system containing viable microorganisms providing a specified resistance to a specified sterilisation process. Chemical compound that forms stable, water soluble complexes on reaction with metal ions. Disinfection achieved by the action of one or more chemical. Test system that reveals change in one or more pre-specified process variables, based on a chemical or physical change resulting from exposure to a process

Biological Indicator

Chelant

Chemical disinfection

Chemical Indicator

Removal of contaminants to the extent necessary for further processing or for intended use.

Cleaning

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