For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization
part of the eto gas sterilization process during which ethylene oxide and/or its
reaction products desorb from the medical device until predetermined levels are reached
Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room.
3.2 aeration area
either a chamber or a room in which aeration occurs
3.3 Bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO/TS 11139:2006, definition 2.2]
3.4 biological indicator
test system containing viable microorganisms providing a defined resistance to a specified eto gas sterilization process
3.5 Calibration
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 realized by standards
3.6 chemical indicator
test system that reveals a change in one or more pre-defined process variables
based on a chemical or physical change resulting from exposure to a process
[SOURCE: ISO/TS 11139:2006, definition 2.6]
treatment of product within the eto gas sterilizationtion cycle, but prior to ethylene
oxide admission, to attain a predetermined temperature and relative humidity
Note 1 to entry: This part of the ethylene oxide sterilization cycle can be carried out either at atmospheric pressure or under vacuum.
Note 2 to entry: See 3.27, preconditioning
3.8 D value
D10 value
time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated conditions
[SOURCE: ISO/TS 11139:2006, definition 2.11] ?
Note 1 to entry: For the purposes of this International Standard, the D value is the exposure time required to achieve 90 % inactivation of the population of the test organism.
3.9 Development
act of elaborating a specification
[SOURCE: ISO/TS 11139:2006, definition 2.13]
3.10 dew point
The temperature at which the saturation water vapour pressure is equal to the
partial pressure of the water vapour in the atmosphere
Note 1 to entry: Any cooling of the atmosphere below the dew point would produce water condensation.
3.11 Establish
determine by theoretical evaluation and confirm by experimentation
[SOURCE: ISO/TS 11139:2006, definition 2.17]
9ISO 11135-2014
3.12 ethylene oxide (EO) injection time
duration of the stage beginning with the first introduction of the EO (mixture) into the chamber to the completion of that injection
3.13 exposure time
period for which the process parameters are maintained within their specified tolerances
[SOURCE: ISO/TS 11139:2006, definition 2.18]
Note 1 to entry: For the purpose of calculation of cycle lethality, it is the period of ethylene oxide sterilization between the end of EO injection and the beginning of EO removal.
3.14 Fault
one or more of the process parameters lying outside of its/their specified
tolerance(s)
[SOURCE: ISO/TS 11139:2006, definition 2.19]
3.15 Flushing
procedure by which the ethylene oxide is removed from the load and chamber
by either multiple alternate admissions of filtered air, inert gas or steam and evacuations of the chamber or continuous passage of filtered air, inert 10ISO 11135-2014 gas or steam through the load and chamber
3.16 fractional cycle
a cycle in which the exposure time to EO gas is reduced compared to that
specified in the ethylene oxide sterilization process
3.17 half cycle
a cycle in which the exposure time to EO gas is reduced by 50 % compared to that specified in the ethylene oxide sterilization process
3.18 health care facility
governmental and private organizations and institutions devoted to the
promotion and maintenance of health, and the prevention and treatment of
diseases and injuries
EXAMPLE A health care facility can be a hospital, nursing home, extended care facility, free-standing surgical centre, clinic, medical office, or dental office.
3.19 health care product
medical device(s), including in vitro diagnostic medical device(s), or medicinal product(s), including biopharmaceutical(s)
11ISO 11135-2014
[SOURCE: ISO/TS 11139:2006, definition 2.20]
3.20 installation qualification
process of obtaining and documenting evidence that equipment has been provided
and installed in accordance with its specification
[SOURCE: ISO/TS 11139:2006, definition 2.22]
3.21 medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,
— investigation, replacement or modification or support of the anatomy or of a physiological process,
— control of conception,
— disinfection of medical devices,
— providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means
[SOURCE: ISO 13485:2003, definition 3.7]
?
3.22 microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
Note 1 to entry: A specific standard might not require demonstration of the
effectiveness of the eto gas sterilization process in inactivating all types of
microorganisms, identified in the definition above, for validation and/or
routine control of the eto gas sterilization process.
3.23 operational qualification
process of obtaining and documenting evidence that installed equipment
operates within predetermined limits when used in accordance with its
operational procedures
[SOURCE: ISO/TS 11139:2006, definition 2.27]
3.24 overkill approach
approach using eto gas sterilization process that delivers a minimum of 12 Spore Log
Reduction (SLR) to a biological indicator having a resistance equal to or greater than the product bioburden
3.25 parametric release
declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances
[SOURCE: ISO/TS 11139:2006, definition 2.29]
Note 1 to entry: This method of process release does not include the use of biological indicators.
3.26 performance qualification
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification
[SOURCE: ISO/TS 11139:2006, definition 2.30]
treatment of product, prior to the eto gas sterilization cycle, in a room or chamber to attain specified conditions for temperature and relative humidity
3.28 process challenge device
item designed to constitute a defined resistance to aeto gas sterilization process and used to assess performance of the process
[SOURCE: ISO/TS 11139:2006, definition 2.33]
Note 1 to entry: For the purpose of this International Standard, a PCD can
be product, simulated product or other device that is inoculated directly or
indirectly. See 7.1.6 and D.7.1.6.
Note 2 to entry: In this International Standard, a distinction is made between an internal PCD and an external PCD. An internal PCD is used to demonstrate that the required product SAL is achieved. A PCD located within the confines of the product or product shipper case is an internal PCD, whereas a PCD located between shipper cases or on the exterior surfaces of the load is an external PCD. An external PCD is an item designed to be used for microbiological
monitoring of routine production cycles.
3.29 process parameter
specified value for a process variable
Note 1 to entry: The specification for a eto gas sterilization process includes the
process parameters and their tolerances.
[SOURCE: ISO/TS 11139:2006, definition 2.34]
3.30 process variable
condition within a ethylene oxide sterilization process, changes in which alter microbicidal effectiveness
EXAMPLE?Time, temperature, pressure, concentration, humidity, wavelength.
[SOURCE: ISO/TS 11139:2006, definition 2.35]
3.31 processing category
collection of different product or product families that can be sterilized
together
Note 1 to entry: All products within the category have been determined to present an equal or lesser challenge to the ethylene oxide sterilization process than the process challenge device for that group.
3.32 Product
result of a process
[SOURCE: ISO 9000:2005, definition 3.4.2]
Note 1 to entry: For the purposes of ethylene oxide sterilization standards, product is
tangible and can be raw material(s), intermediate(s), sub-assembly(ies) and
health care products.
3.33 product family
group of product possessing characteristics that allow them to be sterilized
using defined process conditions
3.34 product load volume
defined space within the usable chamber volume occupied by product
3.35 recognized culture collection
depository authority under the Budapest Treaty on The International
Recognition of the Deposit of
Microorganisms for the Purposes of Patent and Regulation
[SOURCE: ISO/TS 11139:2006, definition 2.38]
3.36 reference microorganism
microbial strain obtained from a recognized culture collection
3.37 Requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified process
3.38 reusable medical device
medical device designated or intended by the manufacturer as suitable for
reprocessing and re-use
Note 1 to entry: This is not a medical device that is designated or intended
by the manufacturer for single use only.
3.39 Services
supplies from an external source, needed for the correct function of equipment
EXAMPLE Electricity, water, compressed air, drainage.
[SOURCE: ISO/TS 11139:2006, definition 2.41]
3.40 single-use medical device
medical device designated or intended by the manufacturer for one-time use only
3.41 Specify
stipulate in detail within an approved document
3.42 Spore-log-reduction log of initial spore population, N0, minus the log of the final population, Nu
[SOURCE: ISO 14161:2009, definition 3.19]
Note 1 to entry: Describing the reduction in the number of spores on a
biological indicator or inoculated item produced by exposure to specified
conditions.
For Direct Enumeration:
SLR = log N0 log ? Nu
where
N0 is the initial population;
Nu is the final population.
For Fraction Negative:
SLR = log N0 – log [ln (q/ /n)]
where
N0 is the initial population;
q is the number of replicate samples tested;
n is the number of samples negative for growth.
If there are no survivors, the true SLR cannot be calculated. The SLR can be
reported as “greater than” log N0 if one surviving organism is used.
3.43 Sterile
free from viable microorganisms
[SOURCE: ISO/TS 11139:2006, definition 2.43]
3.44 sterile barrier system
minimum package that prevents ingress of microorganisms and allows aseptic
presentation of the product at the point of use
[SOURCE: ISO/TS 11139:2006, definition 2.44]
3.45 Sterility
state of being free from viable microorganisms
Note 1 to entry: In practice, no such absolute statement regarding the absence of microorganisms can be proven.
Note 2 to entry: See 3.47, sterilization.
[SOURCE: ISO/TS 11139:2006, definition 2.45]
3.46 sterility assurance level
probability of a single viable microorganism occurring on an item after
sterilization
Note 1 to entry: The term SAL takes a quantitative value, generally 10-6 or 10-3. When applying this quantitative value to assurance of sterility, an SAL of 10-6 has a lower value but provides a greater assurance of sterility than an SAL of 10-3.
[SOURCE: ISO/TS 11139:2006, definition 2.46]
validated process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial
inactivation is exponential and thus the survival of a microorganism on an individual item can be expressed in terms of probability. While this
probability can be reduced to a very low number, it can never be reduced to zero. ISO 11135-2014
Note 2 to entry: See 3.46, sterility assurance level.
[SOURCE: ISO/TS 11139:2006, definition 2.47]
treatment in a sealed chamber, which includes air removal, conditioning (if used), injection of ethylene oxide, inert gas (if used), exposure to ethylene oxide, removal of ethylene oxide and flushing (if used), and air/inert gas admission
3.49 sterilization load
product to be, or that has been, sterilized together using a given
sterilization process
[SOURCE: ISO/TS 11139:2006, definition 2.48]
series of actions or operations needed to achieve the specified requirements for sterility
[SOURCE: ISO/TS 11139:2006, definition 2.49]
Note 1 to entry: This series of actions or operations includes preconditioning
(if necessary), exposure to the ethylene oxide under defined conditions and any necessary post-treatment required for the removal of ethylene oxide and its by-products. It does not include any cleaning, disinfection or packaging operations that precede the sterilization process.
3.51 sterilization specialist
person with technical knowledge of the sterilization technology being utilized and its effects upon materials and microorganisms
3.52 sterilizing agent
ination of entities having sufficient microbicidal activity to achieve sterility under defined conditions
[SOURCE: ISO/TS 11139:2006, definition 2.50]
3.53 survivor curve
graphical representation of the inactivation of a population of microorganisms with increasing exposure to a microbicidal agent under stated conditions
[SOURCE: ISO/TS 11139:2006, definition 2.51]
3.54 test for sterility
technical operation defined in a Pharmacopoeia performed on product following exposure to a sterilization process
[SOURCE: ISO/TS 11139:2006, definition 2.53]
3.55 test of sterility
technical operation performed as part of development, validation, or
requalification to determine the presence or absence of viable microorganisms on product or portions thereof
[SOURCE: ISO/TS 11139:2006, definition 2.54]
3.56 usable chamber volume
defined space within the sterilizer chamber, which is not restricted by fixed or mobile parts and which is available to accept the sterilization load
Note 1 to entry: The volume allowed for gas circulation around the load inside
the chamber is not included as usable space.
documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications
[SOURCE: ISO/TS 11139:2006, definition 2.55]
3.58 virgin material
material that has not been previously used, or subjected to processing other than for its original production
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