oSIST prEN ISO 15883-1:2021
(Main)Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO/DIS 15883-1:2020)
This European Standard specifies general performance requirements for washer- disinfectors and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as the accessories which may be required to achieve the necessary performance.
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO/DIS 15883-1:2020)
Diese Europäische Norm legt allgemeine Leistungsanforderungen an Reinigungs-/Desinfektionsgeräte und deren Zubehörteile fest, die für die Reinigung und Desinfektion wiederverwendbarer Medizinprodukte in der medizinischen, zahn- medizinischen, pharmazeutischen und veterinärmedizinischen Praxis bestimmt sind. Sie legt die Leistungsanforderungen für die Reinigung und Desinfektion sowie die Zusatzeinrichtungen fest, die zum Erreichen der erforderlichen Leistung notwendig sein können.
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO/DIS 15883-1:2020)
La présente partie du prEN ISO 15883 précise les exigences générales de performances pour les laveurs désinfecteurs (LD) et leurs accessoires destinés à être utilisés pour nettoyer et désinfecter des dispositifs médicaux réutilisables ou tout autre article utilisé dans le contexte d'activités médicales, pharmaceutiques, dentaires et vétérinaires. Elle précise les exigences de performances pour le nettoyage et la désinfection ainsi que pour les accessoires qui peuvent être nécessaires pour atteindre les performances requises. Les méthodes et l'instrumentation nécessaires pour la validation, le contrôle de routine, la surveillance et la revalidation, réalisés périodiquement et après des réparations essentielles, sont aussi précisées.
Les exigences pour les laveurs désinfecteurs destinés à traiter des charges spécifiques sont précisées dans des parties subséquentes de la présente Norme. Les laveurs désinfecteurs destinés à traiter des charges d'au moins deux types différents doivent satisfaire les exigences de toutes les parties applicables de la présente Norme.
La présente Norme ne précise aucune exigence en ce qui concerne les laveurs désinfecteurs utilisés en blanchisserie ou en restauration générale.
La présente Norme n'inclut aucune exigence pour les laveurs désinfecteurs destinés à stériliser la charge ou considérées comme des stérilisateurs : celles ci sont précisées dans d'autres normes, par exemple EN 285.
Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in preskusi (ISO/DIS 15883-1:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2021
Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in
preskusi (ISO/DIS 15883-1:2020)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
(ISO/DIS 15883-1:2020)
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und
Prüfverfahren (ISO/DIS 15883-1:2020)
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais
(ISO/DIS 15883-1:2020)
Ta slovenski standard je istoveten z: prEN ISO 15883-1
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-12-04 2021-02-26
Washer-disinfectors —
Part 1:
General requirements, terms and definitions and tests
Laveurs désinfecteurs —
Partie 1: Exigences générales, termes et définitions et essais
ICS: 11.080.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15883-1:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
ISO/DIS 15883-1:2020(E)
© ISO 2020
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO/DIS 15883-1:2020(E)
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Performance requirements .10
4.1 General .10
4.2 Cleaning .14
4.2.1 General.14
4.2.2 Pre-wash stage .14
4.2.3 Washing stage .14
4.2.4 Rinsing stage .15
4.3 Disinfection .15
4.3.1 Thermal disinfection .15
4.3.2 Chemical disinfection . .15
4.4 Final rinsing .16
4.5 Drying .16
4.6 Process chemicals .17
4.7 Self-disinfection .17
5 Mechanical and process requirements .18
5.1 Materials, design and manufacture/construction .18
5.1.1 Materials .18
5.1.2 Design and manufacture/construction .19
5.1.3 Load carrier(s) .20
5.2 Safety .20
5.3 Tanks .21
5.4 Loading and unloading doors and their controls .22
5.4.1 General.22
5.4.2 Control of manually operated doors .23
5.4.3 Control of doors of a double-ended WD .23
5.4.4 Internal doors and access ports .23
5.4.5 Continuous process WD without doors .23
5.5 Pipework and fittings .24
5.5.1 General.24
5.6 Spray systems.24
5.7 Dosing systems .25
5.8 Load temperature protection .25
5.9 Process temperature control limits .26
5.10 Switches, gauges and indicating devices .27
5.11 Process verification .27
5.12 Instrumentation and controls .28
5.13 Temperature indicating systems .30
5.14 Pressure indicating systems .30
5.15 Volume indicating devices .31
5.16 Timing equipment .31
5.17 Operating cycle indicating equipment .31
5.18 Recording instruments (if fitted) .32
5.18.1 Requirements for cycle control recorders .32
5.18.2 Requirements for process verification recorders.32
5.19 Control systems .34
5.20 Override of automatic control.35
5.21 Microprocessor control systems.35
ISO/DIS 15883-1:2020(E)
5.22 Fault indication systems .36
5.23 Water supply .36
5.24 Venting and drainage systems .37
5.25 Drainage .37
5.26 Air filters installed within the WD .37
5.27 Load handling and supports for use within the WD .38
5.28 Trolleys .38
5.29 Environment .39
6 Testing for conformity .39
6.1 General .39
6.1.1 Inter-relationship of tests .39
6.1.2 Conformity of WD, as supplied, with ISO 15883-1 .39
6.1.3 Conformity of WD, as installed, with ISO 15883-1 .39
6.1.4 Confirmation of validation .41
6.1.5 Requalification .41
6.1.6 Process control and monitoring .41
6.2 Instrumentation for testing .42
6.2.1 Temperature sensors .42
6.2.2 Temperature recording instruments .42
6.2.3 Calibration .42
6.3 Tests on doors, interlocks and fault indications .43
6.3.1 Operating cycle start interlock .43
6.3.2 Door locking during operating cycle .43
6.3.3 Door interlocks on double-ended WD .43
6.3.4 Cycle complete door interlocks .44
6.3.5 Fault indication on sensor failure.44
6.3.6 Fault indication on service failure .44
6.3.7 Failed cycle interlock .44
6.3.8 Blocked drain protection .45
6.4 Tests on water quality and water volume .45
6.4.1 General.45
6.4.2 Quality of final rinse water .46
6.4.3 Volume of water used per stage .46
6.4.4 Quality of water used during testing .47
6.5 Tests on pipework .47
6.5.1 Estimation of dead volume pipework .47
6.5.2 Leakage .48
6.5.3 Free draining [tanks, chamber, load carrier(s)] .48
6.5.4 Pipework flow to discharge point .48
6.5.5 Venting .48
6.5.6 Load contamination from ductwork of the WD .49
6.6 Tests on instrumentation fitted to the WD .49
6.6.1 Verification of calibration .49
6.6.2 Legibility .50
6.7 Tests on load carrier(s) and trolleys .50
6.7.1 Load carrier(s) used within the chamber .50
6.7.2 Trolleys .50
6.8 Thermometric tests .51
6.8.1 General.51
6.8.2 Load temperature test . .51
6.8.3 Chamber wall temperature test .52
6.8.4 Temperature tests on tanks .53
6.8.5 Load temperature protection . .53
6.9 Chemical dosing tests .54
6.9.1 Dispensed volume . .54
6.9.2 Indication of insufficient process chemical for a cycle .54
6.10 Tests of cleaning efficacy .55
6.10.1 General.55
iv © ISO 2020 – All rights reserved
ISO/DIS 15883-1:2020(E)
6.10.2 Cleaning type test .55
6.10.3 Cleaning performance qualification test .55
6.10.4 Tests for process residuals .55
6.11 Tests of air quality .56
6.11.1 General.56
6.11.2 Procedure .56
6.11.3 Results .56
6.12 Test of load dryness .56
6.12.1 General.56
6.12.2 Material .56
6.12.3 Procedure .56
6.12.4 Results .56
6.13 Test of automatic control .56
6.13.1 General.56
6.13.2 Procedure .57
6.13.3 Results .57
7 Documentation .57
8 Information to be supplied .58
8.1 General .58
8.2 Before delivery of the WD and for installation .58
8.3 At delivery of the WD . .59
9 Marking, labelling and packaging .61
9.1 Marking and labelling .61
9.2 Packaging .61
10 Information to be requested from the purchaser by the supplier of the WD .61
Annex A (informative) Test programme .63
Annex B (informative) A concept — Comparative lethality of moist heat processes .67
Annex C (normative) Microbiological recovery medium for estimation of bacterial
contamination of water .71
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .72
Annex ZB (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .76
Bibliography .81
ISO/DIS 15883-1:2020(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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 15883-1:2006), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— incorporation of ISO 15883-1:2006/Amd1: 2014;
— alignment with terms and definitions with ISO 11139:2018;
— addition of requirements for load carrier(s);
— clarification of water quality requirements;
— relocation of former Annex C, Test methods for the detection and assessment of residual proteinaceous
1)
contamination, to ISO/FDIS 15883-5:2020 ,
— redesignation of former Annex D, Microbiological recovery medium for estimation of bacterial
contamination of water, as Annex C;
— increase in the minimum temperature limit for thermal disinfection and calculation of A values
from 65 °C to 70 °C;
— revision of the Bibliography.
A list of all parts in the ISO 15883 series can be found on the ISO website.
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.
1) Under preparation.
vi © ISO 2020 – All rights reserved
ISO/DIS 15883-1:2020(E)
Introduction
This document is the first part of the ISO 15883 series of standards specifying the performance of
washer-disinfectors and specifies the general requirements for performance applicable to all washer-
disinfectors. The requirements given in this document are applicable to all washer-disinfectors
specified in subsequent parts of the ISO 15883 series, except insofar as they are modified or added to
by a subsequent part, in which case the requirements of that particular part apply.
Fields of application within the scope of ISO 15883 series can include laboratory, veterinary, dental and
pharmaceutical applications and other specific applications, such as washer-disinfectors for bedsteads
and transport carts and the disinfection of crockery and cutlery intended for use with immunologically
compromised patients.
Washer-disinfectors are used only for processing the type of loads specified by the manufacturer of the
washer-disinfector.
In selecting the appropriate washer-disinfector, references are made both to this document and to the
relevant parts of ISO 15883 series. It is the user’s responsibility to ensure that the choice of type of
washer-disinfector, operating cycle or quality of services or process chemicals is appropriate for any
particular load.
This document has been prepared on the basis that each individual washer-disinfector is subject to
validation tests (e.g. installation qualification, operational qualification, and performance qualification
on first installation) and that in use continued compliance is established by periodic tests.
In respect of the potential adverse effects on the quality of water intended for human consumption or
environmental impacts caused by the washer-disinfector and its intended use, it is noteworthy that the
ISO 15883 series of standards provides no information as to whether the washer-disinfectors may be
used without restrictions in any of the ISO member states.
DRAFT INTERNATIONAL STANDARD ISO/DIS 15883-1:2020(E)
Washer-disinfectors —
Part 1:
General requirements, terms and definitions and tests
1 Scope
This document specifies general performance requirements for washer-disinfectors and their
accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It
specifies performance requirements for cleaning and disinfection as well as for the accessories that
can be required to achieve the necessary performance. The methods and instrumentation required for
validation, routine control and monitoring and requalification, periodically and after essential repairs,
are also specified.
NOTE 1 The requirements can be applied to washer-disinfectors intended for use with other articles used in
the context of medical, dental, pharmaceutical and veterinary practice.
The requirements for washer-disinfectors intended to process specific loads are specified in other parts
of the ISO 15883 series. For washer-disinfectors intended to process loads of two or more different
types the requirements of all relevant parts of the ISO 15883 series apply.
This document does not specify requirements intended for machines for use for laundry or general
catering purposes.
This document does not include requirements for machines which are intended to sterilize the load, or
[21]
which are designated as “sterilizers”, these are specified in other standards, e.g. EN 285 .
The specified performance requirements of this standard do not ensure the inactivation or removal of
the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 2 If it is considered that prion protein can be present, particular care is needed in the choice of cleaning
agents and disinfectants to ensure that the chemicals used do not react with the prion protein in a manner that
can inhibit its removal or inactivation.
This document can be used by prospective purchasers and manufacturers as the basis of agreement on
the specification of a washer-disinfector. The test methods for demonstration of conformity with the
requirements of this document can also be employed by users to demonstrate continued conformity of
the installed washer-disinfector throughout its service life. Guidance on a routine test programme is
given in Annex A.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 7000, Symboles graphiques utilisables sur le matériel — Symboles enregistrés
ISO 10012, Systèmes de management de la mesure — Exigences pour les processus et les équipements
de mesure
ISO 14644-3, Salles propres et environnements maîtrisés apparentés — Partie 3: Méthodes d'essai
ISO 14971, Dispositifs médicaux — Application de la gestion des risques aux dispositifs médicaux
ISO/DIS 15883-1:2020(E)
ISO/FDIS 15883-5:2020 ,Washer-disinfectors – Part 5: Performance requirements and test method criteria
for demonstrating cleaning efficacy
IEC 60417-DB, Graphical symbols for use on equipment
IEC 60584-1:2013, Thermocouples — Part 1: EMF specifications and tolerances
IEC 60751:2008, Industrial platinum resistance thermometer sensors
IEC 61010-2-040:2015, Safety requirements for electrical equipment for measurement, control and
laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat
medical materials
IEC 61326-1:2012, Electrical equipment for measurement, control and laboratory use. EMC requirements –
Part 1: General requirements
IEC 80416-1, Principes de base pour les symboles graphiques utilisables sur le matériel — Partie 1: Création
des symboles graphiques pour enregistrement
European Pharmacopoeia Assays – 2.5.30 Oxidising substances; Biological tests - 2.6.14 Bacterial
endotoxins
United States Pharmacopeia Chemical tests <541> Titrimetry, Oxidation-Reduction (Redox) titrations;
Biological tests <85> Bacterial endotoxins test
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 https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
NOTE Terms and definitions relevant to ISO/TC 198 Sterilization of health care products are listed in
ISO 11139.
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
Note 1 to entry: See Annex B.
[SOURCE: ISO 11139:2018, 3.1, modified – Note 1 to entry has been added]
3.2
automatic controller
device that directs the equipment sequentially through required stages of the cycle in response to
programmed cycle parameters
[SOURCE: ISO 11139:2018, 3.18]
3.3
bedpan washer-disinfector
washer-disinfector for human waste containers that additionally empties and flushes
[SOURCE: ISO 11139:2018, 3.22]
2 © ISO 2020 – All rights reserved
ISO/DIS 15883-1:2020(E)
3.4
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.5
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 11139:2018, 3.31]
3.6
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
[SOURCE: ISO 11139:2018, 3.32]
3.7
chamber
part of equipment in which a load is processed
Note 1 to entry: The chamber does not include steam generators, pipework, e.g. drain and fittings from which it
can be isolated.
[SOURCE: ISO 11139:2018, 3.36, modified – Note 1 to entry has been added]
3.8
chemical disinfection
disinfection achieved by the action of one or more chemicals
[SOURCE: ISO 11139:2018, 3.42]
3.9
cleaning
removal of contaminants to the extent necessary for further processing or for intended use
[SOURCE: ISO 11139:2018, 3.46]
3.10
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.
[SOURCE: ISO 11139:2018, 3.62]
3.11
cycle complete
message from the automatic controller that the operating cycle has ended successfully
[SOURCE: ISO 11139:2018, 3.71]
ISO/DIS 15883-1:2020(E)
3.12
D value
D value
time or dose required under stated conditions to achieve inactivation of 90% of a population of the test
microorganisms
[SOURCE: ISO 11139:2018, 3.75]
3.13
dead volume
enclosed space of pipework which is not purged by the usual flow of liquids
during the operating cycle
[SOURCE: ISO 11139:2018, 3.318.2]
3.14
disinfection
process to inactivate viable microorganisms to a level previously specified as being appropriate for a
defined purpose
[SOURCE: ISO 11139:2018, 3.84]
3.15
disinfection temperature
minimum temperature on which the evaluation of the disinfection efficacy is based
Note 1 to entry: Several disinfection temperatures can prevail during the disinfection stage.
[SOURCE: ISO 11139:2018, 3.85, modified – Note 1 to entry has been added]
3.16
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.
[SOURCE: ISO 11139:2018, 3.86]
3.17
double-ended
having separate doors for loading and unloading in separate areas
[SOURCE: ISO 11139:2018, 3.92]
3.18
endoscope washer-disinfector
washer-disinfector intended to clean and disinfect loads comprising flexible endoscopes
[SOURCE: ISO 11139:2018, 3.100]
3.19
fail safe
attribute of equipment, or its associated services, that ensures that a malfunction will not give rise to a
hazardous situation
[SOURCE: ISO 11139:2018, 3.115]
4 © ISO 2020 – All rights reserved
ISO/DIS 15883-1:2020(E)
3.20
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified
tolerance(s)
[SOURCE: ISO 11139:2018, 3.116]
3.21
fluid
substance that continually deforms (flows) under applied shear stress
EXAMPLE Liquid, gas, vapour, plasma.
[SOURCE: ISO 11139:2018, 3.120]
3.22
flushing
purging
removing by displacement with a fluid
[SOURCE: ISO 11139:2018, 3.121]
3.23
free draining
allowing the unimpeded flow of liquids towards the discharge point under the influence of gravity
[SOURCE: ISO 11139:2018, 3.124]
3.24
holding time
period during which process parameters are maintained, within their specified tolerances
[SOURCE: ISO 11139:2018, 3.133]
3.25
human waste
body fluids and excretions
EXAMPLE Faeces, urine, blood, pus, vomit, mucus.
[SOURCE: ISO 11139:2018, 3.134]
3.26
human waste container
vessel for holding and transporting human waste
[SOURCE: ISO 11139:2018, 3.135]
3.27
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]
3.28
load
product, equipment, or materials to be processed together within an operating cycle
[SOURCE: ISO 11139:2018, 3.155]
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.