Sterilization Validation Services Glossary of Terms

TERM DEFINITION
Bacteria Living single cell w/out organized nucleus (>0.22 micron).
Biological Indicator (BI) A test system containing viable microorganisms providing a
defined resistance to a specified sterilization process
Cleaning Physical removal of organic soil from an item to the extent necessary for
further processing or for the intended use.
Disinfectant An agent that destroys pathogenic and other kinds of microorganisms by
chemical or physical means. A disinfectant destroys most recognized pathogenic
microorganisms, but not necessarily all microbial forms, such as bacterial spores.
Decontamination A process that destroys pathogens and other microorganisms by physical
or chemical means. Decontamination processes do not ensure the same margin of safety
associated with sterilization processes. The lethality of the decontamination process may
vary, depending on the nature of the disinfectant, which leads to the following
subcategories:
a. High Level Decontamination: A lethal process utilizing a sterilant under less than
sterilizing conditions. The process kills all forms of microbial life except for
large numbers of bacterial spores.
b. Intermediate Level Decontamination: A lethal process utilizing an agent that kills
viruses, mycobacteria, fungi and vegetative bacteria, but no bacterial spores.
c. Low Level Decontamination: A lethal process utilizing an agent that kills vegetative
forms of bacteria, some fungi, and lipid viruses.
Germicide An agent that destroys microorganisms, especially pathogenic organisms.
Other terms with the suffix –cide(e.g., virucide, fungicide, bactericide, sporicide, tuberculocide) indicate an agent that destroys the microorganism identified by the
prefix.
Microbial contamination Living (viable) organism.
Physical/chemical sterilization process indicator A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device. (21CFR 880.2800(b))
Process Validation Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
Reprocessing Validated processes used to render a medical device that has been previously used or contaminated, fit for a subsequent single use on another patient. These processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization.
Reusable Medical Device A device intended for repeated use either on the same or different patients, with appropriate cleaning and other reprocessing between uses.
Single Use Device (SUD) A SUD is a device that is intended for one use or on a single patient during a single procedure.
Spore (or endospore) The dormant state of a microorganism, typically a bacterium or fungus, which exhibits a lack of biosynthetic activity, reduced respiratory activity, and has resistance to heat, radiation, desiccation and various chemical agents.
Sterilant An agent that destroys all viable forms of microbial life.
Sterile State of being free from viable microorganisms.
Sterilization A validated process used to render product free from viable microorganisms.
Sterilization wrap A sterilization wrap (pack, sterilization wrapper, bag, or
accessories) is a device intended to be used to enclose another medical device that is to
be sterilized by a health care provider. It is intended to allow sterilization of the
enclosed medical device and also to maintain sterility of the enclosed device until
used. (21 CFR 880.6850)