absorbent surgical towel | Typically, a low-lint 100 % cotton surgical towel woven with a plain weave (1:1) |
ambulatory care | Short-term treatment of medical, dental, or surgical needs within 24 hours in a medical office or clinic |
asepsis | Prevention of contact with microorganisms |
bacterial count | Method of estimating the number of bacteria per unit sample |
bioburden | Population of viable microorganisms on a product and/or a package. |
biofilm | Accumulated biomass of bacteria and extracellular material that is tightly adhered to a surface and connot be removed easily (Donlan,2002) |
biological indicator (BI) | Test system containing viable microorganisms providing a defined resistance to a specified sterilization process. |
Bowie-Dick test | Diagnostic test of a dynamic-air-removal steam sterilizer’s ability to remove air from the chamber and prevent air re-entrainment |
case/cassette | Sterilization containment device that consists of a lid and base tray that has perforations to allow the sterilant to penetrate and that is enclosed in a sterilization wrap (or sterilization pouches suitable for specified sterilization method) to maintain sterility. |
catalase | Enzyme found in almost all cells except for certain anaerobic bacteria |
chemical indicators (CIs) | Devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or are used in specific tests of sterilization equipment |
chemical vapor sterilization | Specific sterilization process that uses a solution of alcohol, water, and inert ingredients, with trace formaldehyde (less than 0.25 %), which is heated to produce an unsaturated vapor with temperature, pressure, and exposure time within specified limits. |
cleaning | Removal of contamination from an item to the extent necessary for further processing or for the intended use. |
clinical soil | Substance consisting of the inorganic, organic, and biological matter typically found on medical instruments after clinical use |
container system, rigid sterilization | Sterilization containment device designed to hold medical devices for sterilization, storage, transportation, and aseptic presentation of contents |
containment device | Reusable rigid sterilization container, instrument case, cassette, or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization |
contaminated | State of having been actually or potentially in contact with microorganisms |
culture | Growth of microorganisms in or on a nutrient medium that supports their multiplication; to grow microorganisms in or on such a medium. |
culture medium | Substance or preparation used to grow and cultivate microorganisms |
cycle, steam sterilization, dynamic-air-removal type | One of two types of sterilization cycles in which air is removed from the chamber and the load by means of a series of pressure and vacuum excursions (prevacuum cycle) or by means of a series of steam flushes and pressure pulses above atmospheric pressure (steam-flush pressure-pulse [SFPP] cycle). |
cycle, steam sterilization, gravity-displacement type | Type of sterilization cycle in which incoming steam displaces residual air through a port or drain in or near the bottom (usually) of the sterilizer chamber |
cycle, sterilization | Defined sequence of operational steps designed to achieve sterilization and carried out in a sealed chamber. See also cycle time. |
cycle time | Total elapsed time of a sterilization cycle from the time the process is initiated until the cycle is completed |
D value | Time or dose required to achieve inactivation of 90 % of a population of a test microorganism under stated exposure conditions |
decasing/breakout area or space | Unpacking area or space where products are removed from their external shipping containers before being taken into the preparation and packaging area or the sterile storage area |
decontamination | According to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy blood-borne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.” [29 CFR 1910.1030] |
decontamination area | Area of a health care facility designated for collection, retention, and cleaning of soiled and/or contaminated items |
disinfection | Process that kills pathogenic and other microorganisms by physical or chemical means |
distilled water | Water that has been heated to the boiling point, vaporized, cooled, condensed into a liquid condensate, and collected so that no impurities are reintroduced. |
drying time | Time required to dry steam-sterilized items before they are handled |
dust cover | Protective plastic bag used to maintain the sterility of an item by protecting it from environmental contamination such as moisture, dust, and lint; also known as a sterility maintenance cover |
entrainment | Collecting or transporting of solid particles or a second fluid or vapor by the flow of the primary fluid or vapor |
eukaryotic cell | Cell with a true nucleus containing chromosomes. The cells of higher plants and animals fungi, protozoa, and most algae are eukaryotic. |
expiration date | Date that is calculated by adding a specific period of time to the date of manufacture or sterilization of a medical device or component and that defines its estimated useful life. |
expiration statement | Statement, also known as a day-to-day expiration date, indicating that the contents of a package are sterile indefinitely unless the integrity of the package is compromised |
exposure time | Period for which the process parameters are maintained within their specified tolerances |
flash sterilization | Process designed for the steam sterilization of patient care items for immediate use |
foot-candle | Standard unit of illumination equivalent to the light produced by one standard candle at a distance of 1 foot |
gasket, container | Pliable strip that serves as a seal between the lid and the base of a reusable rigid sterilization container to prevent entry of microorganisms |
Gram-negative bacteria | Bacteria that are decolorized when stained by Gram’s method, but take on the color of the counterstain |
Gram-positive bacteria | Bacteria that are not decolorized by Gram’s method, but retain the original violet color |
Gram’s method of staining | Method of differential staining used in microbiological identification. |
heat sink | Heat-absorbent material; a mass that readily absorbs heat. |
heat-up time | Time required for the entire load to reach the selected sterilizing temperature after the chamber has reached that temperature |
high-level disinfection | Process that kills all microbial organisms but not necessarily large numbers of bacterial spores |
huck towel | All-cotton surgical towel with a honeycomb-effect weave. |
implant/implantable device | According to FDA, “device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also ‘implants.’ ” [21 CFR 812.3(d)]. |
incubator | Apparatus for maintaining a constant and suitable temperature for the growth and cultivation of microorganisms |
infectious microorganisms | Microorganisms capable of producing disease in the appropriate hosts |
installation qualification (IQ) | Process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specifications. |
intermediate-level disinfection | Process that kills viruses, mycobacteria, fungi, and vegetative bacteria, but not necessarily bacterial spores. |
labeling | Any legend, work, or mark attached to, included in, belonging to, or accompanying any medical device or product |
liquid-proof material | Material historically considered to provide the highest level of barrier protection According to ANSI/AAMI PB70, a liquid-proof material would be defined as a Level 4 barrier material |
liquid-resistant material | Material that inhibits the penetration of liquids. According to ANSI/AAMI PB70, a liquid-resistant material would be defined as a Level 1, 2, or 3 barrier material. |
lot control number (load control number) | Numbers, letters, or a combination of both, by which a particular group of products can be traced to a particular manufacturing or sterilization operation |
low-level disinfection | Process that kills most vegetative bacteria, some viruses, and some fungi, but not mycobacteria or bacterial spores. |
master product | (Sterilization) product designated as representative of all members of a product family This product has the most difficult-to-sterilize attributes of any member of the family |
microbicidal process | Process designed to provide a particular level of microbial lethality (kill). |
microorganism | Entity, encompassing bacteria, fungi, protozoa, and viruses, of microscopic size. |
minimum recommended concentration (MRC) | minimum concentration at which the manufacturer of a liquid chemical sterilant or high-level disinfectant tested the product and validated its performance |
muslin | Broad term describing a wide variety of plain-weave cotton or cotton/polyester fabrics having approximately 140 threads per square inch approximately 140 threads per square inch |
nonrestricted area | Area where traffic is not limited and where attire is not prescribed |
nonreturn/nonrecirculating ventilation system | Ventilation system that exhausts 100 % of the air supplied to a space to the outside environment. |
occupational exposure | Contact, through inhalation, ingestion, skin contact, or absorption, with a potentially hazardous material during the course of employment. Occupational exposure to hazardous materials including chemical and biological agents and potentially infectious materials, is regulated by OSHA |
office-based health care facility | Health care facility designed for short-term treatment of ambulatory patients (e.g., freestanding surgical centers, clinics, and medical and dental offices |
operational qualification (OQ) | Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures |
organizing case | Reusable metal or plastic containment device that organizes and protects instruments and components in specified locations within the device, and that is usually wrapped with an approved wrapping material |
paper–plastic packaging | Single-use packaging, including preformed pouches, with a clear plastic side to permit visibility of the contents and an opaque paper side that can be penetrated by air or steam or other sterilant |
par level | Optimum supply level, usually applicable to inventory, that is based on predetermined quotas established from usage studies |
parenteral | Situated or occurring outside of the intestines; injection of substances into the body through any route other than the alimentary canal (e.g., subcutaneous, intravenous, intramuscular, or intrathecal injection |
pasteurization | Disinfection process using hot water at temperatures of 65 °C to 77 °C (150 °F to 170 °F) for a contact time of at least 30 minutes (min). |
performance qualification (PQ) | Process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with |
preconditioned | Held at room temperature (20 °C to 23 °C [68 °F to 73 °F]) and at a relative humidity ranging from 30 % to 60 % for a minimum of 2 hours |
process challenge device (PCD) | Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process |
processing area | Area of a health care facility in which decontaminated, clean instruments, and other medical and surgical supplies are inspected, assembled into sets and trays, and wrapped, packaged, or placed into rigid sterilization container systems for subsequent sterilization |
product family | (Sterilization) group or subgroup of product that is characterized by similar attributes, such as mass, material, construction, set weight, shapes, lumens, and packaging system, and that presents a similar challenge to the sterilization process |
pyrogen | Fever-producing substance |
restricted area | Area where access and traffic are limited to authorized personnel and where attire might be prescribed. |
reusable medical device | Device intended for repeated use on different patients, with appropriate decontamination and other processing between uses. |
saturated steam | Water vapor in a state of equilibrium between condensation and evaporation |
shelf life | When the term is used with respect to a sterilized medical device, the period of time during which the item is considered safe to use |
steam purity | Degree to which steam is free of dissolved and suspended particles, water treatment chemicals, and other contaminants |
steam quality | Steam characteristic reflecting the dryness fraction (weight of dry steam present in a mixture of dry saturated steam and entrained water) and the level of noncondensable gas (air or other gas that will no condense under the conditions of temperature and pressure used during the sterilization process |
steam sterilization | Sterilization process that uses saturated steam under pressure, for a specified exposure time and at a specified temperature, as the sterilizing agent. |
sterile | Free from viable microorganisms |
sterile storage area | Area of a health care facility designed to store clean and sterile items and protect them from contamination |
sterility assurance level (SAL) | Probability of a single viable microorganism occurring on an item after sterilization. |
sterilization | Validated process used to render a product free from viable microorganisms |
sterilization area | Area of a health care facility where sterilization activities take place. |
sterilizer | Apparatus used to sterilize medical devices, equipment, and supplies by direct exposure to the sterilizing agentsterilizing agent |
sterilizer, steam | Sterilizer that uses saturated steam under pressure as the sterilant |
strike-through | Passage of a liquid that could contain microorganisms through a barrier product, including its seams and/or points of attachment |
superheat | Temperature excess above the temperature of saturated steam at the same pressure. |
table-top sterilizer | Compact steam sterilizer that has a chamber volume of not more than 2 cubic feet and that generates its own steam when distilled or deionized water is added by the user |
terminal sterilization | Validated process whereby product within its primary package is sterilized |
treated water | Water that has been processed to reduce impurities |
user verification | Documented procedures, performed in the user environment, for obtaining, recording,and interpreting the results required to establish that predetermined specifications have been met |
validation | Documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications |