Active drain:

Air detector:

Air removal:

Automatic controller:

Automatic control test:

Bioburden:

Biological indicator:

Calibration:

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.

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.

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.

NOTE: The holding time follows immediately after the equilibration time. The extent of the holding time is related to the sterilization temperature

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.

NOTE: These temperatures are usually stated in whole degrees Celsius.

Sterilizer:

Apparatus designed to achieve sterilization.

Sterilizer chamber:

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.