EN ISO 11139:2018

SLOVENSKI STANDARD
01-december-2018
Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri
sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO 11139:2018)
Sterilization of health care products - Vocabulary of terms used in sterilization and
related equipment and process standards (ISO 11139:2018)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der
Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird (ISO
11139:2018)
Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de
procédés de stérilisation et les équipements connexes (ISO 11139:2018)
Ta slovenski standard je istoveten z: EN ISO 11139:2018
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11139
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2018
EUROPÄISCHE NORM
ICS 01.040.11; 11.080.01
English Version
Sterilization of health care products - Vocabulary of terms
used in sterilization and related equipment and process
standards (ISO 11139:2018)
Stérilisation des produits de santé - Vocabulaire des Sterilisation von Produkten für die
termes utilisés dans les normes de procédés de Gesundheitsfürsorge - Vokabular, das bei der
stérilisation et les équipements connexes (ISO Sterilisation und zugehöriger Ausrüstung sowie in
11139:2018) Prozessnormen verwendet wird (ISO 11139:2018)
This European Standard was approved by CEN on 1 September 2018.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11139:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11139:2018) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2019, and conflicting national standards shall
be withdrawn at the latest by March 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to CEN Internal Regulations, terms and definition are always developed for a specific subject
of the relevant standard/specification of the relevant working group. The working group uses the
advice of the terminology working group to ensure that new terms and definitions are in line with the
regulations and not in conflict with existing terms and definitions. Whenever possible, terms and
definitions can be taken form the terminology standard EN ISO 11139.
ISO 11139 mentions a „White Paper“ in the ISO Foreword. CEN does not endorse this „White Paper“ for
the following reasons:
 there was no official standardisation request for the preparation of such a document,
 the document has not been developed according to CEN Internal Regulations and
 the document is outside the scope of EN ISO 11139.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11139:2018 has been approved by CEN as EN ISO 11139:2018 without any modification.
INTERNATIONAL ISO
STANDARD 11139
First edition
2018-08
Sterilization of health care products —
Vocabulary of terms used in
sterilization and related equipment
and process standards
Stérilisation des produits de santé — Vocabulaire des termes utilisés
dans les normes de procédés de stérilisation et les équipements
connexes
Reference number
ISO 11139:2018(E)
©
ISO 2018
ISO 11139:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 11139:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
Annex A (informative) Summary of standards in which each term is included in their
respective Clause 3 .33
Bibliography .45
ISO 11139:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This first edition of ISO 11139 cancels and replaces ISO/TS 11139:2006, which has been technically
revised.
The main changes compared with the previous edition are as follows:
— all the terms and definitions have been reviewed based on existing documents in the field and future
needs, and have been revised accordingly for consistency of use;
NOTE This vocabulary is now the source document for these terms.
— additional terms and definitions have been added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved

ISO 11139:2018(E)
Introduction
This document provides the fundamental vocabulary for sterilization of health care products and
associated equipment. It provides the foundation for other standards on cleaning, disinfecting,
sterilizing, and aseptic processing of health care products together with associated equipment and
ancillary products used in ensuring effective application of these processes. This document is intended
to help the user to understand the vocabulary of cleaning, disinfecting, sterilizing, and aseptically
processing health care products, in order to be able to implement the related standards effectively.
This document contains the terms and definitions that apply to all standards on cleaning, disinfecting,
sterilizing, and aseptic processing of health care products together with associated equipment
and ancillary products developed by ISO/TC 198 and other European standards in the same field of
application.
The terms and definitions are arranged in alphabetical order in English.
ISO/TC 198 has produced a white paper describing the principles used to develop this compilation
of terms and definitions and proposals on its use in the development of new and revised standards
for disinfecting, sterilizing, and aseptic processing of health care products together with associated
equipment and ancillary products. This white paper is available through the International Organization
for Standardization.
The Bibliography includes the standards referenced in Annex A. If a term has been dropped in a current
revision, reference has not been made.
INTERNATIONAL STANDARD ISO 11139:2018(E)
Sterilization of health care products — Vocabulary of terms
used in sterilization and related equipment and process
standards
1 Scope
This document defines terms in the field of the sterilization of health care products including related
equipment and processes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
A
measure of microbiological lethality delivered by a moist heat disinfection process expressed in terms
of the equivalent time in seconds at 80 °C with reference to a microorganism with a z value of 10 K
3.2
absolute pressure
pressure for which the zero value is associated with absolute vacuum
3.3
absorbed dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
3.4
access device
means by which entry to restricted parts of equipment is achieved
Note 1 to entry: This can be by dedicated key, code, or tool.
3.5
action level
value from monitoring that necessitates immediate intervention
3.6
active ingredient
chemical or biological component that is included in the formulation of a health care product to achieve
the intended purpose
3.7
aeration
part of the sterilization cycle during which the sterilizing agent and/or its reaction products desorb
from the health care product until predetermined levels are reached
ISO 11139:2018(E)
3.8
air break
physical separation in water supply pipes to prevent back flow from equipment
3.9
air detector
device designed to detect the presence of non-condensable gases in the chamber or in a stream of steam
and condensate
3.10
airlock
enclosure with interlocked doors designed to maintain pressure control between adjacent areas
3.11
alert level
value from monitoring providing early warning of deviation from specified conditions
3.12
analyte
chemical substance that is the subject of chemical analysis
3.13
aseptic presentation
transfer of sterile contents from its sterile barrier system using conditions and procedures that
minimize the risk of microbial contamination
3.14
aseptic processing
handling of sterile product, containers, and/or devices in a controlled environment in which the air
supply, materials, equipment, and personnel are regulated to maintain sterility
3.15
aseptic processing area
APA
facilities for aseptic processing, consisting of several zones
3.16
aseptic technique
conditions and procedures used to minimize the risk of the introduction of microbial contamination
3.17
assurance of sterility
qualitative concept comprising all activities that provide confidence that product is sterile
3.18
automatic controller
device that directs the equipment sequentially through required stages of the cycle in response to
programmed cycle parameters
3.19
bacterial challenge test
technical operation performed to evaluate the capability of a filter to retain
microorganisms from a liquid bacterial suspension under specified conditions
3.20
bacteriostasis/fungistasis test
technical operation performed to detect the presence of substances that inhibit microbial multiplication
2 © ISO 2018 – All rights reserved

ISO 11139:2018(E)
3.21
batch
defined quantity of a product intended or purported to be uniform in character and quality produced
during a specified cycle of manufacture
3.22
bedpan washer-disinfector
washer-disinfector for human waste containers that additionally empties and flushes
3.23
bioburden
population of viable microorganisms on or in a product and/or sterile barrier system
3.24
bioburden correction factor
numerical value applied to a viable count to compensate for incomplete removal of microorganisms
from a product and/or failure to culture microorganisms
3.25
bioburden estimate
value established by applying a correction factor to a bioburden count
3.26
bioburden spike
individual bioburden value that is significantly greater than other bioburden values in a set
3.27
bio-decontamination
removal and/or reduction of biological contaminants to an acceptable level
3.28
biological contaminant
cell or biological entity other than the intended components present in product
EXAMPLE Viruses, bacteria, fungi, protozoa, multicellular parasites, contaminating eukaryotic cells,
aberrant proteins known as prions, endotoxins, or active DNA/RNA.
Note 1 to entry: This can include extrinsic and/or intrinsic contaminants.
Note 2 to entry: A biological entity is a functional assembly of biological molecules or structures, and could be an
enzyme complex, a membranous structure, ribosomes, etc., or a combination thereof, that is kept assembled to
maintain its biological functionality.
3.29
biological indicator
test system containing viable microorganisms providing a specified resistance to a specified
sterilization process
3.30
block
group of channels comprising part of an endoscope with specified lengths, diameters, and
interconnections
3.31
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity
values with measurement uncertainties provided by measurement standards and corresponding
indications with associated measurement uncertainties and, in a second step, uses this information to
establish a relation for obtaining a measurement result from an indication
[SOURCE: ISO/IEC Guide 99:2007, 2.39, modified — The notes to entry have been deleted.]
ISO 11139:2018(E)
3.32
calorifier
closed vessel, at a pressure greater than atmospheric, in which water is indirectly heated by the flow of
heated fluid through a heat exchanger
3.33
carrier
supporting material on or in which test microorganisms are deposited
3.34
cell-based
containing or consisting of prokaryotic or eukaryotic cells or cell derived biological entities
Note 1 to entry: A biological entity is a functional assembly of biological molecules or structures, and could be an
enzyme complex, a membranous structure, ribosomes, etc., or a combination thereof that is kept assembled to
maintain its biological functionality.
3.35
cell-processing area
CPA
area for processing cell-based materials consisting of different zones for processing and, where
applicable, for containment
3.36
chamber
part of equipment in which a load is processed
3.37
chamber pre-heating
process that raises the temperature of internal chamber surfaces prior to the commencement of an
operating cycle
3.38
chamber reference temperature
temperature at a specified point within the chamber
3.39
change control
assessment and determination of the appropriateness of a proposed alteration to product, process, or
equipment
3.40
channel separator
device used to keep apart interconnected fluid pathways
EXAMPLE A device inserted in a trumpet valve cylinder where multiple channels meet in order to separate
the air and water pathways in the air/water valve assembly.
3.41
chemical compatibility
capability of process fluids and filter materials to be used together, under the specified process
conditions, without adverse effects on either the fluids or filter materials
3.42
chemical disinfection
disinfection achieved by the action of one or more chemicals
3.43
chemical indicator
test system that reveals change in one or more pre-specified process variables based on a chemical or
physical change resulting from exposure to a process
4 © ISO 2018 – All rights reserved

ISO 11139:2018(E)
3.43.1
chemical indicator system
combination of a chemical indicator and a specific test load
3.44
chemical indicator endpoint
completion of a specified change after a chemical indicator has been exposed to specified conditions
3.45
clean
visually free of soil and below specified levels of analytes
3.46
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
3.47
cleaning agent
physical or chemical entity, or combination of entities, having activity to render an item clean
3.48
clean-in-place
CIP
cleaning of internal surfaces of parts of equipment or an entire process system, without or with
minimal, disassembly
3.49
clinical use
use of a health care product during a procedure on a patient
3.50
closed system
means to prevent egress of hazardous agents and ingress of extrinsic
contamination
3.51
closure
means used to complete a sterile barrier system where no seal is formed
3.52
closure integrity
characteristics of a closure to minimize the risk of ingress of microorganisms
3.53
colony forming unit
CFU
visible aggregation of microorganisms arising from a single cell or multiple cells
3.54
combination product
entity presented as a single health care product that physically, chemically, or otherwise brings together
or mixes items regulated under separate legislation
Note 1 to entry: The entity could be a combination of medical device and medicinal product or biopharmaceutical
product.
ISO 11139:2018(E)
3.55
combined standard measurement uncertainty
standard measurement uncertainty that is obtained using the individual standard measurement
uncertainties associated with the input quantities in a measurement model
[SOURCE: ISO/IEC Guide 99:2007, 2.31, modified — The admitted term and the Note 1 to entry have
been deleted.]
3.56
come-down period
time elapsed from the termination of the exposure period to an established null
reaction point
3.57
come-up period
time elapsed from the introduction of the sterilizing agent to the attainment of the
specified conditions
3.58
conditioning
treatment of product prior to the exposure phase to attain a specified temperature, relative humidity,
or other process variable throughout the load
3.59
containment
combination of buildings, engineering functions, equipment, and work practices that allow safe handling
of hazardous biological or chemical substances, and prevent accidental release of these substances to
the external environment
3.60
containment area
designated location consisting of a cell processing area and an associated degowning room
3.61
containment facility
combination of manufacturing rooms including the containment area and associated rooms within a
physical containment barrier
Note 1 to entry: This can include airlocks, access and support rooms, laboratories, and interconnecting corridors.
Note 2 to entry: A containment facility uses a series of barriers (primary, secondary, and tertiary) to minimize
the escape of hazardous agents to facility workers, the general population, and the environment, e.g. isolators (if
necessary, negative pressure type); biological safety cabinets (Class I, II or III); negative air pressure cleanroom;
personnel protective clothing; appropriate work practices; appropriate disposal of hazardous waste; restriction
of access to the facility.
3.62
continuous process machine
equipment that moves one work unit at a time between each step of the process with the product
generally remaining in motion
Note 1 to entry: This is contrasted with batch process equipment, which would expose the entire batch to each
step of the process, one step at a time.
3.63
control
regulation of variables within specified limits
6 © ISO 2018 – All rights reserved

ISO 11139:2018(E)
3.64
correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in advance of, in conjunction with, or after a corrective action.
[SOURCE: ISO 9000:2015, 3.12.3, modified — The Note 2 to entry has been deleted.]
3.65
corrective action
action to eliminate the cause of a nonconformity and to prevent recurrence
Note 1 to entry: There can be more than one cause for a nonconformity.
Note 2 to entry: Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent
occurrence.
[SOURCE: ISO 9000:2015, 3.12.2, modified – Note 3 to entry has been deleted]
3.66
coverage factor
number larger than one by which a combined standard measurement uncertainty is multiplied to
obtain an expanded measurement uncertainty
Note 1 to entry: A coverage factor is usually symbolized k.
[SOURCE: ISO/IEC Guide 99:2007, 2.38]
3.67
critical processing zone
location within the aseptic processing area in which product and critical surfaces are exposed to the
environment
3.68
critical surface
surface that might come into direct contact with a product, including its containers or closures, posing
a risk of contamination
3.69
culture collection number
unique identification of a test organism allocated by a recognized culture collection
3.70
culture condition
combination of growth media and manner of incubation used to promote germination, growth, and/or
multiplication of microorganisms
Note 1 to entry: The manner of incubation can include the temperature, time, and any other conditions specified
for incubation.
3.71
cycle complete
message from the automatic controller that the operating cycle has ended successfully
3.72
cycle parameter
value of a cycle variable including its tolerance used for control, monitoring, indication, and recording
of an operating cycle
ISO 11139:2018(E)
3.73
cycle time
period of time an irradiation container spends in each dwell position in a gamma process,
used as a control parameter for dose
3.74
cycle variable
property used to control, monitor, indicate, or record an operating cycle
3.75
D value
D value
time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test
microorganisms
3.76
dead leg
area of entrapment in vessel or piping that is not easily accessed
3.77
depyrogenation
process used to remove or deactivate pyrogenic substances to a specified level
Note 1 to entry: Pyrogenic substances include bacterial endotoxins.
3.78
desorption
removal of the sterilizing agent from the chamber and the load at the end of the exposure phase
3.79
development
act of elaborating a specification
3.80
dew point
temperature at which the saturation water vapour pressure is equal to the partial pressure of the water
vapour in the atmosphere
3.81
direct support zone
protective area directly surrounding a critical processing zone
3.82
disinfectant
chemical or combination of chemicals used for disinfection
3.83
disinfecting agent
physical or chemical agent used for disinfection
3.84
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
3.85
disinfection temperature
minimum temperature on which the evaluation of the disinfection efficacy is based
8 © ISO 2018 – All rights reserved

ISO 11139:2018(E)
3.86
disinfection time
period for which the process variable(s) is/are maintained at or above that/those specified
Note 1 to entry: Examples of process variables include temperature of the load, disinfectant concentration in the
chamber.
3.87
dose mapping
measurement of dose distribution and variability in material irradiated under specified
conditions
3.88
dose uniformity ratio
ratio of the maximum to the minimum absorbed dose within the irradiation container
3.89
dosimeter
device having a reproducible, measurable response to radiation that can be used to measure the
absorbed dose in a given system
3.90
dosimetry
measurement of absorbed dose by the use of dosimeters
3.91
dosimetry system
interrelated elements used for determining absorbed dose, including dosimeters, instruments,
associated reference standards, and procedures for their use
3.92
double-ended
having separate doors for loading and unloading in separate areas
3.93
drying stage
part of an operating cycle that is dedicated to removing moisture from the load
3.94
endoscope connector
device to interface with the fluid entry port of a channel of an endoscope that, where applicable, includes
the tubing connected to the channel irrigation system of the washer-disinfector
3.95
endoscope leak test
set of actions to identify a loss of integrity
3.96
endoscope port
part of an endoscope to which the irrigation system of the washer-disinfector is connected to irrigate
all or part of a channel
3.97
endoscope product family
group of endoscopes with comparable design, including the number, construction, and purpose of the
different endoscope channels
ISO 11139:2018(E)
3.98
endoscope surrogate device
item designed to represent construction elements of endoscope specific characteristics affecting the
flow conditions in endoscope channels
Note 1 to entry: Elements can include channel length and diameter, connectors, channel separators, port closures,
return valves, etc.
3.99
endoscope type test group
endoscopes for which the general channel design and specific characteristics affecting the flow
conditions in the endoscope are similar
Note 1 to entry: The general channel design includes lengths and diameters. Characteristics affecting the flow
conditions in the endoscope are, for example, connectors, channel separators, port closures, return valves.
Note 2 to entry: Similar implies that small variations can be possible. Endoscopes that show small variations in
channel specifications that do not lead to a significant variation in the flow and pressure characteristic through
the channels could be in the same endoscope type test group.
3.100
endoscope washer-disinfector
washer-disinfector intended to clean and disinfect loads comprising flexible endoscopes
3.101
endotoxin
lipopolysaccharide component of the cell wall of Gram-negative bacteria that is heat stable and elicits a
variety of inflammatory responses in animals and humans
3.102
environmental control
application of engineering and/or procedural systems to maintain conditions in a defined space within
specified limits
3.103
environmental isolate
microorganism cultured from processing or manufacturing environments
3.104
EO-cartridge
hermetically sealed container that holds a predetermined weight of ethylene oxide (EO) for single use
Note 1 to entry: The EO-cartridge is designed to be used in low volume chambers and/or to be activated while in
the flexible sterilization bag, releasing EO.
3.105
equilibration time
period between the attainment of defined sterilization process parameters at the reference
measurement point and the attainment of the specified sterilization process parameters at all points
within the load
3.106
equipment maintenance
combination of all technical and associated administrative actions intended to keep equipment at a
state in which it can perform its required function, or restore it to such a state
3.107
establish
determine by theoretical evaluation and confirm by experimentation
10 © ISO 2018 – All rights reserved

ISO 11139:2018(E)
3.108
excipient
chemical or biological component other than an active ingredient that is included in a formulation
3.109
expanded measurement uncertainty
product of a combined standard measurement uncertainty and a factor larger than the number one
Note 1 to entry: The factor depends upon the type of probability distribution of the output quantity in a
measurement model and on the selected coverage probability.
Note 2 to entry: The term “factor” in this definition refers to a coverage factor.
[SOURCE: ISO/IEC Guide 99:2007, 2.35, modified — The admitted term has been modified, and Note 3
to entry has been deleted.]
3.110
expiry date
date by which product should be used
3.111
exposure phase
cycle stage between the introduction of the sterilizing or disinfecting agent into the chamber and when
the agent is removed
3.112
extrinsic contamination
ingress of viable or non-viable extraneous material during the manufacturing process
3.113
F value
measure of microbiological lethality delivered by a heat process expressed in terms of the equivalent
time, in minutes, at a specified temperature with reference to microorganisms with a specified z value
3.113.1
F value
measure of microbiological lethality delivered by a moist heat sterilization process expressed in terms
of the equivalent time, in minutes, at a temperature of 121,1 °C with reference to microorganisms with
a z value of 10 K
3.113.2
F value
BIO
expression of the resistance of a biological indicator calculated as the product of the logarithm of the
initial population of microorganisms and the D value
3.113.3
F value
H
measure of microbiological lethality delivered by a dry heat sterilization process expressed in terms
of the equivalent time, in minutes, at a temperature of 160 °C with reference to microorganisms with a
z value of 20 K
3.114
facultative organism
microorganism capable of both aerobic and anaerobic metabolism
3.115
fail safe
attribute of equipment, or its associated services, that ensures that a malfunction will not give rise to a
hazardous situation
ISO 11139:2018(E)
3.116
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified
tolerance(s)
3.117
filter
construct of porous material through which a fluid is passed to remove viable and/or non-viable
particles
3.118
filter integrity test
non-destructive physical technical operation that can be correlated to the bacterial retention capability
of a filter assembly
3.119
flexible sterilization bag
container constructed from a malleable membrane that acts as the sterilization
chamber
Note 1 to entry: The material from which the flexible sterilization bag is manufactured can be either permeable
or impermeable to EO gas.
3.120
fluid
substance that continually deforms (flows) under applied shear force
EXAMPLE Liquid, gas, vapour, plasma.
3.121
flushing
purging
removing by displacement with a fluid
3.122
fraction positive
quotient in which the number of positive tests of sterility is given by the numerator, and the number of
tests performed is given by the denominator
3.123
fractional cycle
operating cycle in which the exposure phase is reduced compared with that specified for the
sterilization cycle
3.124
free draining
allowing the unimpeded flow of liquids towards the discharge point under the influence of gravity
3.125
gas concentration
weight of a specific gas in a given volume
Note 1 to entry: Concentration can be expressed as mg/l or g/m .
3.126
gauge pressure
pressure for which the zero value is associated with atmospheric pressure
3.127
gowning procedure
specified actions for putting on protective garments in a manner commensurate with the cleanliness
level of the room
12 © ISO 2018 – All rights reserved

ISO 11139:2018(E)
3.128
growth promotion test
technical operation performed to demonstrate that a growth medium will support microbial
multiplication
3.129
half cycle
test cycle in which the extent of treatment is reduced by 50 % as compared with an operating cycle
3.130
hazard
potential source of harm
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
3.131
hazardous situation
circumstance in which people, property, or the environment is/are exposed to one or more hazards
[SOURCE: ISO/IEC Guide 51:2014, 3.4]
3.132
health care product
medical device, including in vitro diagnostic medical device, or medicinal product, including
biopharmaceutical
3.133
holding time
period during which process parameters are maintained, within their specified tolerances
3.134
human waste
body fluids and excretions
EXAMPLE Faeces, urine, blood, pus, vomit, mucus.
3.135
human waste container
vessel for holding and transporting human waste
3.136
humidity
measure of water vapour present in a gas
Note 1 to entry: Humidity is usually expressed as absolute humidity (i.e. vapour pressure density), relative
humidity, or dew point.
3.136.1
absolute humidity
measure of water vapour in the air, regardless of temperature
Note 1 to entry: It is expressed as grams of moisture per cubic meter of air (g/m ).
3.136.2
relative humidity
measure of water vapour in the air expressed as a percentage of the maximum for a given temperature
Note 1 to entry: It is expressed as a percent.
ISO 11139:2018(E)
3.137
inactivation curve
graphical representation of decrease in viability of a population of microorganisms with increasing
exposure to a microbicidal agent under stated conditions
3.138
incremental dose
dose within a series of doses applied to a number of product, or portions thereof, and used in a dose
setting method to obtain or confirm the sterilization dose
3.139
indicate
display a value, condition, or stage of process
3.140
indicator exposure period
duration between the initial attainment to the termination of the specified exposure conditions
3.141
indirect dose measurement
measurement of absorbed dose at a location remote from a directly measured dosimeter calculated by
the application of factors
3.142
indirect support zone
location within the aseptic processing area that protects the direct support zone
Note 1 to entry: The required grade of cleanliness of the indirect support zone depends on the aseptic processing
technologies and activities performed.
3.143
influence quantity
quantity that, in a direct measurement, does not affect the quantity that is actually measured, but
affects the relation between the indication and the measurement result
[SOURCE: ISO/IEC Guide 99:2007, 2.52, modified — The examples and the notes to entry have been
deleted.]
3.144
inoculated carrier
supporting material on or in which a specified number of viable test microorganisms has been deposited
3.145
intrinsic contamination
viable and non-viable foreign matter present in cell-based starting material
3.146
irradiation container
holder in which product is transported through the irradiator
Note 1 to entry: The holder can be a carrier, cart, tray, product carton, pallet, or other container.
3.147
irradiator operator
company or body responsible for irradiation of product
3.148
irrigation plan
stipulated direction of flow of process fluids through the specified
channels of an endoscope
14 © ISO 2018 – All rights reserved

ISO 11139:2018(E)
3.149
isolator
enclosure capable of preventing ingress of contaminants by means of physical
separation of the interior from the exterior that is capable of being subject to reproducible interior bio-
decontamination, and where processors always remain separated from the interior of the enclosure by
means of an absolute physical barrier
3.150
isolator system
isolator with transfer system(s) and ancillary equipment
3.151
labelling
label, instructions for use and any other information that is related to identification, technical
description, intended purpose, and proper use of the health care product, but excluding shipping
documents
[SOURCE: ISO 13485:2016, 3.8, modified — The term “medical device” has been replaced by “health
care product”.]
3.152
leachable
substance that can be released from a filter or filter assembly during normal use conditions
3.153
lethal rate
L
measure of inactivation per unit time at temperature, T, expressed in terms of a reference
temperature, T
ref
Note 1 to entry: L is expressed as minutes at the reference temperature, T , per minute at T.
ref
Note 2 to entry: Lethal rate at any temperature can be calculated using the formula:
TT−
()
ref
L=10
z
where
T is the delivered temperature;
T is the reference temperature;
ref
z is the change in temperature that produces a tenfold change in D value.
3.154
liquid transport system
components of equipment used to store, pump, or transport water and/or
solutions, excluding pipework before the air break
3.155
load
product, equipment, or materials to be processed together within an operating cycle
3.156
load configuration
distribution and orientation of a load
3.157
loading door
means of access through which a load is passed into the chamber before processing
ISO 11139:2018(E)
3.158
lumen device
item that consists of tube(s) or pipe(s)
3.159
manual cleaning
removal of contaminants from an item to the extent necessary for further processing or for intended
use without the use of an automated process
3.160
master product
health care product or procedure set used to represent the most difficult to sterilize item in a product
family or processing category
3.161
maximum acceptable dose
dose given in the process specification as the highest dose that can be applied to a specified product
without compromising safety, quality, or performance
3.162
measurement accuracy
closeness of agreement between a measured quantity value and a true quantity value of a measurand
[SOURCE: ISO/IEC Guide 99:2007, 2.13, modified — The admitted terms and the notes to entry have
been deleted.]
3.163
measurement precision
precision
closeness of agreement between indications or measured quantity values obtained by replicate
measurements on the same or similar objects under specified conditions
Note 1 to entry: Measurement precision is usually expressed numerically by measures of imprecision, such as
standard deviation, variance, or coefficient of variation under the specified conditions of measurement.
Note 2 to entry: The “specified conditions” can be, for example, repeatability conditions of measurement,
intermediate precision conditions of measurement, or reproducibility conditions of measurement.
Note 3 to entry: Measurement precision is used to define “measurement repeatability”, “intermediate
measurement precision”, and “measure
...