This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.

se/std-80005894

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
 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

ISO 11139:2018(E)


COPYRIGHT PROTECTED DOCUMENT

© 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

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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 2018 – All rights reserved  iii

 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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.

© ISO 2018 – All rights reserved  v

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894
This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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
A0
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
<radiation> 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 2018 – All rights reserved  1

 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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
<aseptic processing> 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

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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
<endoscope> 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 2018 – All rights reserved  3

 This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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
<biological indicator> 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
<endoscope> 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
<filter> 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

This preview is downloaded from www.sis.se. Buy the entire standard via https://www.sis.se/std-80005894

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
<aseptic processing> means to prevent egress of hazardous agents and ingress of extrinsic
contamination
3.51
closure
<packaging> means used to complete a sterile barrier system where no seal is formed
3.52
closure integrity
<packaging> 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 2018 – All rights reserved  5