NOTE: This is an ideal condition, which can deviate towards either superheated steam or to wet steam. This deviation is quantified by the determination of the Dryness Value. NOTE: The holding time follows immediately after the equilibration time. The extent of the holding time is related to the sterilization temperature NOTE: These temperatures are usually stated in whole degrees Celsius.
Active drain:
A drain, which is situated at the lowest part of the sterilizer chamber to control the discharge of air/non-condensable gases or air and condensate from the sterilizer chamber.
Air detector:
A device used to determine that sufficient air or other non-condensable gases have been removed from the chamber.
Air removal:
Removal of air from the sterilizer chamber and sterilizer load sufficient to facilitate steam penetration.
Automatic controller:
Device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the cycle(s).
Automatic control test:
A test designed to show that the operating cycle functions correctly as evidenced by the values of the cycle variables indicated and recorded by the instruments fitted to the sterilizer.
Bioburden:
Population of viable micro-organisms on a product and/or package.
Biological indicator:
An inoculated carrier contained within its primary pack ready for use.
Calibration:
The set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realised by standards.
Chamber depth:
Depth of the sterilizer chamber which is available for the sterilizer load.
Chamber height:
Height of the sterilizer chamber which is available for the sterilizer load.
Chamber width:
Width of the sterilizer chamber which is available for the sterilizer load
Chamber temperature:
Lowest temperature prevailing in the sterilizer chamber.
Chemical Indicator:
A device designed to show, usually by a change of colour; whether specified values of one or more cycle variables nave been attained.
Disinfection:
A process used to reduce the number of viable micro-organisms in a load but which may not necessarily inactivate some viruses and bacterial spores.
Dedicated steam supply:
Supply of steam produced for a sterilizer, or group of sterilizers, by a dedicated generator.
Door:
Lid or similar device provided as a means of closing and sealing the sterilizer chamber.
Double ended sterilizer:
Sterilizer in which there is a door at each end of the sterilizer chamber.
Dryness value:
A dimensionless quantity approximating to the dryness fraction, derived to determine whether steam is of the correct dryness for sterilization purposes. A dryness value of 1.0 represents dry saturated steam.
Dry saturated steam:
Steam with a temperature and pressure corresponding to the vaporisation curve of water.
D-value:
Decimal reduction value (for biological indicators". The time in minutes required to secure inactivation of 90% of the test organisms under stated exposure conditions.
Equilibration time:
Period which elapses between the attainment of the sterilization temperature in the sterilizer chamber and the attainment of the sterilization temperature at all points within the load.
Fail safe:
Attribute of sterilizer design, component or its associated services that minimises a possible safety hazard.
Fault:
Recognition by the automatic controller that the pre-set cycle variables for the sterilization cycle have not been attained.
Holding time:
Period for which the temperature of all points within the sterilizer is held within the sterilization temperature band.
Inoculated carrier:
A carrier on which a defined number of test organisms has been deposited.
Installation test:
Series of checks and tests performed after installation of the sterilizer in the place of use.
Loading door:
Door in a double ended sterilizer through which the sterilizer load is put into the sterilizer chamber prior to sterilization.
Medical device:
The definition given in EN 46001 applies.
Moist heat:
Heat that is derived from water, either as a liquid or as steam under pressure.
Parametric release:
Declaring product as 'sterile' based on physical process data rather than on the basis of sample testing or biological indicator results.
Performance qualification:
Obtaining and documenting evidence that the equipment as commissioned will produce acceptable product when operated in accordance with the process specification.
Plateau period:
Equilibration time plus the holding time.
Primary standard:
Standard that is designated or widely acknowledged as having the highest metrological qualities and whose values are accepted without reference to other standards.
Product compatibility:
Ability of the sterilization cycle to achieve the intended results without detrimental effect on the product.
Non-condensable gas:
Air and other gas which will not condense under the conditions of steam sterilization.
Pressure vessel:
A vessel describing the sterilizer chamber, jacket (if fitted), door(s) and components that are in permanent connection with the sterilizer chamber.
Recommissioning:
Procedure to confirm that the sterilizer functions in accordance with its specification and that data established during commissioning remain valid.
Reference measurement point:
Reference point for which documented evidence is available to demonstrate that it has a known relationship to the temperature of the coolest part of the sterilizer chamber.
Reference load:
Specified load made up to represent the most difficult combination of products to be sterilized.
Reference standard:
Standard, generally having the highest metrological quality available at a given location or in a given organisation, from which measurements made there are derived.
Safety hazard:
Potentially detrimental effect on persons or the surroundings arising directly from either the sterilizer or its load.
Saturated steam:
Water vapour at a temperature corresponding to the boiling point of the source liquid.
Small steam sterilizers:
Steam sterilizer which is unable to accommodate a sterilization module.
Sterile:
Condition of a medical device that is free from viable micro-organisms.
Sterilization:
Process undertaken to render a sterilizer load sterile.
Sterilization cycle:
Automatic sequence of operating stages performed in a sterilizer for the purpose of sterilization.
Sterilization: temperature:
Minimum temperature of the sterilization temperature band.
Sterilization temperature band:
Range of temperatures, expressed as the sterilization temperature and the maximum allowable temperature which may prevail throughout the load during the holding time.
Sterilizer:
Apparatus designed to achieve sterilization.
Sterilizer chamber:
That part of the sterilizer which receives the sterilizer load.
Sterilizer load:
Goods that are to be sterilized simultaneously in the same sterilizer chamber.
Superheated steam:
Steam whose temperature, at any given pressure, is higher than that indicated by the vaporisation curve of water.
Test organism:
Micro-organisms used for the manufacture of inoculated carriers.
Type test:
Series of tests to establish the working data for a sterilizer type.
Unloading door:
Door in a double ended sterilizer through which the sterilized load is removed from the sterilizer chamber after a sterilization cycle.
Usable space:
Space inside the sterilizer chamber which Is not restricted by fixed parts and which is consequently available to accept the sterilizer
load.
NOTE: The usable space is expressed in terms of chamber height, chamber width and chamber depth.
Validation:
Documented procedure for obtaining, recording and interpreting data required to show that a process will consistently comply with predetermined specifications.
Works test:
Series of tests performed at the manufacturer's works to demonstrate compliance of each sterilizer with its specification.