SIST EN ISO 11139:2018
(Main)Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018)
Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards (ISO 11139:2018)
This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO/TC 198 "Sterilization of healthcare products", CEN/TC 204 "Sterilization of medical devices", and CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices".
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular, das bei der Sterilisation und zugehöriger Ausrüstung sowie in Prozessnormen verwendet wird (ISO 11139:2018)
Dieses Dokument definiert Begriffe aus dem Bereich der Sterilisation von Produkten für die Gesundheitsfürsorge einschließlich der zugehörigen Ausrüstung und Verfahren.
Stérilisation des produits de santé - Vocabulaire des termes utilisés dans les normes de procédés de stérilisation et les équipements connexes (ISO 11139:2018)
Le présent document définit les termes employés dans le domaine de la stérilisation des produits de santé, y compris les équipements et processus connexes.
Sterilizacija izdelkov za zdravstveno nego - Slovar izrazov, ki se uporabljajo pri sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO 11139:2018)
Ta mednarodni standard določa pogoje na področju sterilizacije izdelkov za zdravstveno nego, ki se uporabljajo v standardih ISO/TC 198 Sterilizacija izdelkov za zdravstveno nego, CEN/TC 204 Sterilizacija medicinskih pripomočkov ter CEN/TC 102 Sterilizatorji in povezana oprema za obdelavo medicinskih pripomočkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11139:2018
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
SIST EN ISO 11139:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11139:2018
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SIST EN ISO 11139:2018
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.
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SIST EN ISO 11139:2018
EN ISO 11139:2018 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11139:2018
EN ISO 11139:2018 (E)
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.
3
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SIST EN ISO 11139:2018
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SIST EN ISO 11139:2018
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
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SIST EN ISO 11139:2018
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
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Phone: +41 22 749 01 11
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 11139:2018
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
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SIST EN ISO 11139:2018
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
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SIST EN ISO 11139:2018
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
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SIST EN ISO 11139:2018
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SIST EN ISO 11139:2018
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
0
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 2018 – All rights reserved 1
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SIST EN ISO 11139:2018
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
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SIST EN ISO 11139:2018
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.]
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SIST EN ISO 11139:2018
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
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SIST EN ISO 11139:2018
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 2018 – All rights reserved 5
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SIST EN ISO 11139:2018
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
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SIST EN ISO 11139:2018
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 2018 – All rights reserved 7
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SIST EN ISO 11139:2018
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
10
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
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SIST EN ISO 11139:2018
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 11139:2017
01-oktober-2017
Sterilizacija izdelkov za zdravstveno nego - Slovar - Izrazi, ki se uporabljajo pri
sterilizaciji in ustrezni opremi ter pri procesnih standardih (ISO/DIS 11139:2017)
Sterilization of health care products - Vocabulary - Terms used in sterilization and related
equipment and process standards (ISO/DIS 11139:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Vokabular -Begriffe, die bei der
Sterilisation und zugehörigen Geräten sowie in Prozessnormen verwendet werden
(ISO/DIS 11139:2017)
Stérilisation des produits de santé - Vocabulaire (ISO/DIS 11139:2017)
Ta slovenski standard je istoveten z: prEN ISO 11139
ICS:
01.040.11 Zdravstveno varstvo Health care technology
(Slovarji) (Vocabularies)
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11139:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11139:2017
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oSIST prEN ISO 11139:2017
© ISO 2017 – All rights reserved
ISO /TC 198
Date: 2017-06-05
ISO/DIS 11139:2017(E)
ISO/TC 198/WG 5
Secretariat: AAMI (for ANSI)
Sterilization of health care products — Vocabulary - terms used in
sterilization and related equipment and process standards
Stérilisation des produits de santé — Vocabulaire
DIS stage
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oSIST prEN ISO 11139:2017
ISO/DIS 11139:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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ISO/DIS 11139:2017(E)
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Bibliography . 46
Annex A (informative) . 50
Excluded terms . 50
Annex B (informative) . 56
Graphical example of the different time definitions in moist heat disinfection and sterilization
processes to illustrate the use of the terms . 56
Graphical representation of examples of the different period definitions used in a resistometer test . 57
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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 on 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 Committees ISO/TC 198, Sterilization of healthcare products
and CEN/TC102 Sterilizers and associated equipment for processing of medical devices.
This second edition cancels and replaces the first edition ISO/TS 11139:2006, which has been
technically and editorially modified and expanded to include additional terms.
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Introduction
There are of the order of 80 standards in the sterilization and associated areas in the ISO and EN series.
Most of these standards use terms that are used in other standards. ISO/TS 11139 was published in
2006 with a selected list of common terms used in the field. The current version of the Vocabulary
standard has extended its scope to cover all the terms used in each of the current standards, their
revisions in process, and new draft standards. By this means, authors of new standards will be able to
identify terms already in use, and therefore reduce the risk of the same term or abbreviation being used
in a different way.
Under each definition the standards in which the term has been used is referenced. However, the terms
in this document have many instances where the definitions have been updated from the originally
published definitions, and it is expected that the definitions used in individual existing standards will be
updated as each standard is revised. Where a term has been used already in more than one standard it
has required the different ISO and CEN Working Groups employing the same term to agree on a
common definition. There are also instances where the term has been modified as well.
Some terms that have been listed in existing standards, but that are in common usage and in standard
dictionaries have been recommended that they do not need a definition in a sterilization standard:
these terms have been listed in Annex A with the reason for exclusion indicated.
In a Vocabulary standard there are some general rules that have been applied to terms in this
International Standard where they have been used in more than one of the reviewed standards, and
authors of new standards are asked to review their definitions to ensure that these general rules are
followed. For example there should be no requirements included in the definition. The words in the
term should ideally not be repeated in the definition, nor should the definition be circular (e.g. Air
Removal: removal of air).
The membership of the Working Group working on this International Standard has included the
Convenors of the ISO TC198 “Sterilization of healthcare products”, CEN TC204 “Sterilization of medical
devices”, and CEN TC102 “Sterilizers and associated equipment for processing of medical devices”
Working Groups.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 11139:2017(E)
Sterilization of health care products — Vocabulary - terms used in
sterilization and related equipment and process standards
1 Scope
This International Standard defines terms in the field of sterilization of healthcare products used in the standards
developed by ISO TC198 “Sterilization of healthcare products”, CEN TC204 “Sterilization of medical devices”, and
CEN TC102 “Sterilizers and associated equipment for processing of medical devices”.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
A
0
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
[Term used in: ISO 15883-1:2009 + A1:2014; ISO15883-2:2009; ISO15883-3:2009]
3.2
absolute pressure
pressure for which the zero value is associated with absolute vacuum
[Term used in: EN 285:2015; EN 764-1:2004]
3.3
absorbed dose
quantity of ionizing radiation energy imparted per unit mass of a specified material
[Term used in: ISO 11137-1:2015; ISO/TS 13004:2014]
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
[Term used in: EN 285:2015; EN 14180:2014]
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3.5
action level
value from monitoring that necessitates immediate intervention
[Term used in: ISO 13408-1:2015]
3.6
active ingredient
chemical or biological component that is included in the formulation of a healthcare product in sufficient
concentration to achieve the intended therapeutic purpose of the specific product
[Term used in: ISO 18362:2016]
3.7
aeration
part of the sterilization cycle during which the sterilizing agent and/or its reaction products desorb from the
medical device until predetermined levels are reached
[Term used in: EN 1422:2014; EN 14180:2014; ISO 11135:2014; ISO/DIS 25424:2017]
3.8
air break
physical separation in water supply pipes to prevent back flow from equipment
[Term used in: ISO/DIS 15883-4:2016]
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
[Term used in: ISO 17665-1:2006]
3.10
airlock
enclosure with interlocked doors designed to maintain pressure control between adjacent areas
[Term used in: ISO 13408-1:2015]
3.11
alert level
value from monitoring providing early warning of deviation from specified conditions
[Term used in: ISO 13408-1:2015]
3.12
analyte
chemical substance that is the subject of chemical analysis
[Term used in: ISO/FDIS 15883-4:2017; ISO/CD 15883-5:2017]
3.13
aseptic presentation
transfer of sterile product using conditions and procedures that minimise the risk of microbial contamination
[Term used in: ISO/DIS 11607-1:2017]
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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
[Term used in: EN 556-2:2015; ISO 13408-1:2015]
3.15
aseptic processing area
APA
facilities for aseptic processing, consisting of several zones
[Term used in: 13408-1:2015]
3.16
aseptic technique
conditions and procedures used to minimise the risk of the introduction of microbial contamination
[Term used in: ISO/DIS 11138-7:2017; ISO 13408-1:2015; ISO 18362:2016]
3.17
assurance of sterility
qualitative concept comprising all activities that provide confidence that product is sterile
[Term used in: ISO/TS 19930:2017]
3.18
automatic controller
device that directs the equipment sequentially through required stages of the cycle in response to programmed
cycle parameters
[Term used in: EN 285:2015; EN 1422:2014; EN 13060:2014; EN 14180:2014; ISO 15883-1:2009 + A1:2014; ISO 17665-
1:2006]
3.19
bacterial challenge test
technical operation performed to evaluate the capability of a filter to retain organisms from
a liquid bacterial suspension under defined conditions
[Term used in: ISO/CD 13408-2:2016]
3.20
bacteriostasis/fungistasis test
technical operation performed to detect the presence of substances that inhibit microbial multiplication
[Term used in: ISO 11737-2:2009]
3.21
batch
defined quantity of product intended or purported to be uniform in character and quality, which has been
produced during a defined cycle of manufacture
[Term used in: ISO 11137-2:2015; ISO/FDIS 11737:2017; ISO/TS 13004:2014; ISO 14160:2011; ISO 20857:2013]
3.22
bedpan washer-disinfector
washer-disinfector for human waste containers that additionally empties and flushes
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[Term used in: ISO 15883-1:2009 + A1:2014]
3.23
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[Term used in: EN 556-1:2001; EN 556-2:2015; ISO 11135:2014; ISO 11137-1:2015; ISO 11137-2:2015; ISO/DIS 11138-
7:2017; ISO/DIS 11607-1:2017; ISO/FDIS 11737:2017; ISO 11737-2:2009; ISO/TS 13004:2014; ISO 13408-1:2015; ISO/CD
13408-2:2016; ISO 14160:2011; ISO 14937:2009; ISO 15883-1:2009 + A1:2014; ISO 17665-1:2006; ISO/TS 19930:2017; ISO
20857:2013; ISO/DIS 25424:2017]
3.24
bioburden correction factor
numerical value applied to a viable count to compensate for incomplete removal of microorganisms from product
and/or failure to culture of microorganisms
[Term used in: ISO/FDIS 11737:2017]
3.25
bioburden estimate
value established by applying a correction factor to a bioburden count
[Term used in: ISO/FDIS 11737:2017]
3.26
bioburden spike
an individual bioburden value that is significantly greater than other bioburden values in a set
[Term used in: ISO/FDIS 11737:2017]
3.27
bio-decontamination
removal and/or reduction of biological contaminants to an acceptable level
[Term used in: ISO 13408-1:2015; ISO 13408-6:2011 + A1:2013]
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.
[Term used in: ISO 18362:2016]
3.29
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[Term used in: EN 1422:2014; EN 13060:2014; EN 14180:2014; ISO 11135:2014; ISO 11137-1:2015; ISO 11138-1:2017;
ISO/DIS 11138-7:2017; ISO/CD 11138-8:2015; ISO 14937:2009; ISO 17665-1:2006; ; ISO/FDIS 18472:2017; ISO/TS
19930:2017; ISO 20857:2013; ISO/DIS 25424:2017]
3.30
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block
group of channels comprising part of an endoscope with specified lengths, diameters and
interconnections
[Term used in: ISO/DIS 15883-4:2016]
3.31
calibration
operation that, under specified conditions, in a first step, establishes a relation between the quantity values with
measurement uncertainties provided by the 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: VIM:2012]
[Term used in: EN 1422:2014; EN 13060:2014; ISO 11135:2014; ISO 11137-1:2015; ISO 15883-1:2009 + A1:2014; ISO 17665-
1:2006; ISO/FDIS 18472:2017; ISO 20857:2013; ISO/DIS 25424:2017]
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
[Term used in: ISO 15883-1:2009 + A1:2014]
3.33
carrier
supporting material on or in which test microorganisms are deposited
[Term used in: ISO 11138-1:2017; ISO/CD 11138-8:2015; ISO 14160:2011]
3.34
cell-based
containing or consisting of pro- or eukaryotic cells or cell derived biological entities
[Term used in: ISO 18362:2016]
3.35
cell-processing area
CPA
area for processing cell-based materials consisting of different zones for processing and, where applicable, for
containment
[Term used in: ISO 18362:2016]
3.36
chamber
part of equipment in which a load is processed
[Term used in: EN 285:2015; EN 13060:2014; EN 14180:2014; ISO 15883-1:2009 + A1:2014; ISO 17665-1:2006]
3.37
chamber pre-heating
raising the temperature of internal chamber surfaces prior to the commencement of an operating cycle
[Term used in: EN 14180:2014]
3.38
chamber reference temperature
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temperature at a defined point within the chamber
[Term used in: ISO 11140-4:2007]
3.39
change control
assessment and determination of the appropriateness of a proposed alteration to product, process or equipment
[Term used in: ISO 11137-1:2015; ISO 14937:2009; ISO/TS 19930:2017; ISO 20857:2013; ISO/DIS 25424:2017]
3.40
channel separator
device that is used to keep apart interconnected fluid pathways
Note 1 to entry: For 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
[Term used in: ISO/DIS 15883-4:2016]
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
[Term used in: ISO/CD 13408-2:2016]
3.42
chemical disinfection
removal or reduction of microorganisms achieved by the action of one or more chemicals
[Term used in: ISO 15883-1:2009 + A1:2014]
3.43
chemical indicator
test system that reveals change in one or more pre-defined process variables based on a chemical or physical
change resulting from exposure to a process
[Term used in: EN 13060:2014; ISO 11135:2014; ISO 11140-1:2014; ISO 11140-5:2007; ISO 14937:2009; ISO 15882:2008; ISO
17665-1:2006; ISO/FDIS 18472:2017:2016; ISO/TS 19930:2017; ISO 20857:2013; ISO/DIS 25424:2017]
3.44
chemical indicator endpoint
completion of a defined change after a chemical indicator has been exposed to specified conditions
[Term used in: ISO 11140-1:2014; ISO 15882:2008]
3.45
clean
visually free of soil and quantified as being below specified levels of analytes
[Term used in: ISO/CD 15883-5:2017]
3.46
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
[Term used in: ISO 13408-1:2015; ISO 15883-1:2009 + A1:2014; ISO/FDIS 17664-1:2017]
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3.47
cleaning agent
physical or chemical entity, or combination of entities, having sufficient activity to render an item clean
[Term used in: ISO 13408-4:2011]
3.48
clean-in-place
CIP
cleaning of internal surfaces of parts of equipment or an entire process system, without or with minimal,
disassembly
[Term used in: ISO 13408-4:2011]
3.49
clinical use
use of a medical device during a procedure on a patient
[Term used in: ISO/CD 15883.5:2017]
3.50
closed system
means to prevent egress of hazardous agents and ingress of extrinsic contamination
[Term used in: ISO 18362:2016]
3.51
closure integrity
characteristic of the closure to minimize the risk of ingress of microorganisms demonstrated under test conditions
which consider sterilization process, handling, distribution, transport and storage
[Term used in: ISO/DIS 11607-1:2017]
3.52
colony forming unit
CFU
visible unit of growth of microorganisms arising from a single cell or multiple cells
[Term used in: ISO 11138-1:2017; ISO/DIS 15883-4:2016]
3.53
combination product
entity presented as a single healthcare product that physically, chemically or otherwise brings together or mixes
items regulated under separate legislation
Note 1 to entry: The entity might be a combination of medical device and medicinal product or biopharmaceutical.
[Term used in: ISO 13408-1:2015]
3.54
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: VIM:2012]
[Term used in: ISO 11137-3:2017]
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3.55
come-down period
time elapsed from the termination of the exposure period to an established null reaction point
[Term used in: ISO/FDIS 18472:2017]
3.56
come-up period
time elapsed from the introduction of the sterilizing agent to the attainment of the specified
conditions
[Term used in: ISO/FDIS 18472:2017]
3.57
conditioning
treatment of product prior to the exposure phase to attain a specified temperature, relative humidity, or other
process variable throughout the load
[Term used in: EN 1422:2014; EN 14180:2014; ISO 11135:2014; ISO/DIS 25424:2017]
3.58
contained product
load for which the ambient media within a chamber do not come into direct contact with the item to be processed
[Term used in: ISO 17665-1:2006]
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
[Term used in: ISO 18362:2016]
3.60
containment area
designated location consisting of a cell processing area and the associated degowning room
[Term used in: ISO 18362:2016]
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.
[Term used in: ISO 18362:2016]
3.62
continuous process machine
equipment for a process that moves one work unit at a time between each step of the process with the product
generally remaining in motion
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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.
[Term used in: ISO 15883-1:2009 + A1:2014]
3.63
control
regulation of variables within specified limits
[Term used in: EN 1422:2014]
3.64
correction
action to eliminate a detected nonconformity
Note 1 to entry: A correction can be made in conjunction with a corrective action
[SOURCE: ISO 9000:2015]
[Term used in: ISO 11137-1:2015; ISO/FDIS 11737:2017; ISO/TS 13004:2014; ISO 13408-1:2015; ISO 14937:2009; ISO
17665-1:2006; ISO/TS 19930:2017; ISO 20857:2013]
3.65
corrective action
situation 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]
[Term used in: ISO 11137-1:2015; ISO/FDIS 11737:2017; ISO/TS 13004:2014; ISO 13408-1:2015; ISO 14937:2009; ISO
17665-1:2006; ISO/TS 19930:2017; ISO 20857:2013]
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: VIM:2012]
[Term used in: ISO 11137-3:2017]
3.67
critical process parameter
See: process parameter
3.68
critical processing zone
location within the aseptic processing area in which product and critical surfaces are exposed to the environment
[Term used in: ISO 13408-1:2015]
3.69
critical surface
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surface that might come into direct contact with a product, including its containers or closures, posing a risk of
contamination
[Term used in: ISO 13408-1:2015]
3.70
culture collection number
unique identification of a test organism allocated by a recognised culture collection
[Term used in: ISO 11138-1:2017]
3.71
culture conditions
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 may include the temperature, time, and any other conditions specified for
incubation.
[Term used in: ISO 11138-1:2017; ISO/CD 11138-8:2015; ISO/FDIS 11737:2017; ISO 11737-2:2009]
3.72
cycle complete
message from the automatic controller that the operating cycle has ended successfully
[Term used in: EN 285:2015; EN 1422:2014; EN 14180:2014; ISO 15883-1:2009 + A1:2014]
3.73
cycle control recorder
device that records the values of one or more process variables from the automatic controller
[Term used in: ISO 15883-1:2009 + A1:2014]
3.74
cycle parameter
value of a cycle variable including its tolerance used for control, monitoring, indication and recording of an
operating cycle
[Term used in: EN 285:2015; EN 13060:2014; EN 14180:2014]
3.75
cycle time
period of time an irradiation container spends in each dwell position in a gamma process, used as a
control parameter for dose
[Term used in : ISO/WD 11137-4:2107]
3.76
cycle variable
property used to control, monitor, indicate, or record an operating cycle
[Term used in: EN 14180:2014]
3.77
D value
D value
10
time or dose required under stated conditions to achieve inactivation of 90 % of a population of the test
microorganisms
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[Term used in: ISO 11135:2014; ISO 11137-1:2015; ISO 11137-2:2015; ISO 11138-1:2017; ISO/DIS 11138-7:2017; ISO/CD
11138-8:2015; ISO 14160:2011; ISO 15883-1:2009 + A1:2014; ISO 17665-1:2006; ISO 20857:2013; ISO/DIS 25424:2017]
3.78
dead leg
area of entrapment in vessel or piping that is not easily accessed
[Term used in: ISO 13408-4:2011; ISO 13408-5:2011]
3.79
depyrogenation
process used to remove or deactivate pyrogenic substances to a specified level
Note 1 to entry: pyrogenic substances include bacterial endotoxins
[Term used in: ISO 13408-1:2015; ISO 20857:2013]
3.80
desorption
removal of the sterilizing agent from the chamber and the load at the end of the exposure phase
[
...
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