INTERNATIONAL ISO

STANDARD 15883-4

Second edition
2018-11

Washer-disinfectors —
Part 4:
Requirements and tests for washer-
disinfectors employing chemical
disinfection for thermolabile
endoscopes
iTeh STANDARD PREVIEW
Laveurs désinfecteurs —
(standards.iteh.ai)
Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à
la désinfection chimique des endoscopes thermolabiles
ISO 15883-4:2018
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Reference number
ISO 15883-4:2018(E)

© ISO 2018
ISO 15883-4:2018(E)


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 ISO 15883-4:2018(E)


Contents Page

Foreword......................................................................................................................................................................................................................................... vi
Introduction............................................................................................................................................................................................................................... vii
1 Scope.................................................................................................................................................................................................................................. 1
2 Normative references....................................................................................................................................................................................... 1
3 Terms and definitions...................................................................................................................................................................................... 2
4 Performance requirements........................................................................................................................................................................ 5
4.1 General............................................................................................................................................................................................................ 5
4.2 Systems for leak testing.................................................................................................................................................................... 7
4.3 Cleaning.......................................................................................................................................................................................................... 9
4.3.1 General...................................................................................................................................................................................... 9
4.3.2 Flushing.................................................................................................................................................................................... 9
4.3.3 Washing.................................................................................................................................................................................... 9
4.3.4 Post-washing rinsing..................................................................................................................................................... 9
4.3.5 Determination of cleaning efficacy................................................................................................................ 10
4.4 Disinfecting.............................................................................................................................................................................................. 10
4.4.1 General................................................................................................................................................................................... 10
4.4.2 Efficacy of the disinfectant.................................................................................................................................... 10
4.4.3 Temperature...................................................................................................................................................................... 11
4.4.4 Process monitoring...................................................................................................................................................... 11

4.5
4.4.5 iTeh STANDARD PREVIEW
Disinfectant use.............................................................................................................................................................. 11
Final rinsing............................................................................................................................................................................................. 12
4.6 (standards.iteh.ai)
Purging to remove rinse water................................................................................................................................................ 12
4.7 Drying........................................................................................................................................................................................................... 13
4.8 Self-disinfection...................................................................................................................................................................................
ISO 15883-4:2018 13
4.9 Water treatment equipment..................................................................................................................................................... 14
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4.9.1 General...................................................................................................................................................................................
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4.9.2 Disinfection of water treatment equipment........................................................................................... 14
4.9.3 Maintenance of piping............................................................................................................................................... 15
5 Mechanical and process requirements.......................................................................................................................................15
5.1 Materials ― Design, manufacture and construction............................................................................................. 15
5.2 Device channel irrigation system.......................................................................................................................................... 16
5.2.1 General................................................................................................................................................................................... 16
5.2.2 ​Verification of device channel irrigation by the automatic controller............................. 17
5.3 Venting and drainage systems................................................................................................................................................. 17
5.4 Temperature control........................................................................................................................................................................ 17
5.4.1 General................................................................................................................................................................................... 17
5.4.2 Temperature control of the washing stage.............................................................................................. 18
5.4.3 Temperature control of the disinfection stage..................................................................................... 18
5.4.4 WD with a minimum operating temperature for the washing and/or
disinfection stage........................................................................................................................................................... 18
5.5 Process chemicals............................................................................................................................................................................... 18
5.6 Process verification........................................................................................................................................................................... 18
5.7 Dosing systems..................................................................................................................................................................................... 19
6 Testing for conformity..................................................................................................................................................................................19
6.1 General......................................................................................................................................................................................................... 19
6.2 Test equipment..................................................................................................................................................................................... 19
6.2.1 General................................................................................................................................................................................... 19
6.2.2 Pressure measurement............................................................................................................................................ 19
6.2.3 Flow measurement...................................................................................................................................................... 19
6.3 Water used for final rinsing....................................................................................................................................................... 20
6.3.1 Principle................................................................................................................................................................................ 20
6.3.2 Material/procedure..................................................................................................................................................... 20

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6.3.3 Results/acceptance criteria.................................................................................................................................. 20

6.4 Hardness of water used during type testing............................................................................................................... 20
6.4.1 Principle................................................................................................................................................................................ 20
6.4.2 Material.................................................................................................................................................................................. 20
6.4.3 Procedure............................................................................................................................................................................. 21
6.5 Leak test...................................................................................................................................................................................................... 21
6.5.1 Principle................................................................................................................................................................................ 21
6.5.2 Material.................................................................................................................................................................................. 21
6.5.3 Procedure............................................................................................................................................................................. 21
6.5.4 Results/acceptance criteria.................................................................................................................................. 22
6.6 Channels non-obstruction test................................................................................................................................................ 24
6.6.1 Principle................................................................................................................................................................................ 24
6.6.2 Material.................................................................................................................................................................................. 24
6.6.3 Procedure............................................................................................................................................................................. 25
6.6.4 Results/acceptance criteria.................................................................................................................................. 25
6.7 Channels non-connection test................................................................................................................................................. 25
6.7.1 Principle................................................................................................................................................................................ 25
6.7.2 Material.................................................................................................................................................................................. 26
6.7.3 Procedure............................................................................................................................................................................. 26
6.7.4 Result/acceptance criteria.................................................................................................................................... 26
6.8 Load dryness........................................................................................................................................................................................... 26
6.8.1 Principle................................................................................................................................................................................ 26
6.8.2 Material.................................................................................................................................................................................. 26
6.8.3 Exterior surface drying............................................................................................................................................ 26

6.9
6.8.4 iTeh STANDARD PREVIEW
Channel drying................................................................................................................................................................ 27
Thermometric tests.......................................................................................................................................................................... 27
6.9.1 (standards.iteh.ai)
Test for chamber and load temperature during operating cycle.......................................... 27
6.9.2 Test for operating cycle temperature limits on washing and chemical
disinfection stages........................................................................................................................................................
ISO 15883-4:2018 28
6.10 Chemical dosing tests for single-dose containers................................................................................................... 28
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6.10.1 Principle................................................................................................................................................................................
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6.10.2 Material.................................................................................................................................................................................. 28
6.10.3 Procedure............................................................................................................................................................................. 28
6.10.4 Results/acceptance criteria.................................................................................................................................. 29
6.11 Tests of cleaning efficacy.............................................................................................................................................................. 29
6.11.1 General................................................................................................................................................................................... 29
6.11.2 Principle................................................................................................................................................................................ 29
6.11.3 Material.................................................................................................................................................................................. 29
6.11.4 Procedure............................................................................................................................................................................. 30
6.11.5 Results/acceptance criteria.................................................................................................................................. 30
6.12 Tests of disinfection efficacy..................................................................................................................................................... 30
6.12.1 General................................................................................................................................................................................... 30
6.12.2 Preliminary tests on chemical disinfectants.......................................................................................... 31
6.12.3 Self-disinfection tests................................................................................................................................................. 33
6.12.4 Test of microbial quality of final rinse water treatment equipment................................. 34
6.12.5 Disinfection of liquid transport systems following failure of water
treatment equipment................................................................................................................................................. 34
6.12.6 Chemical disinfection of the load.................................................................................................................... 35
7 Documentation and inspection...........................................................................................................................................................36
8 Information to be supplied by the manufacturer.............................................................................................................36
9 Marking, labelling and packaging....................................................................................................................................................37
10 Information to be requested from the purchaser by the manufacturer...................................................37
Annex A (informative) Summary of activities covered by this document....................................................................38
Annex B (normative) Microbiological testing of the efficacy of chemical disinfection of the load....40
Annex C (normative) Summary of test programmes.........................................................................................................................44

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Annex D (normative) Methods for microbiological evaluation of disinfection of liquid

transport system................................................................................................................................................................................................48
Annex E (normative) Tests for microbial contamination of final rinse water........................................................53
Annex F (informative) Additional notes on microbiological testing of chemical disinfection
processes....................................................................................................................................................................................................................55
Annex G (informative) Typical specifications of trumpet valves and connection ports...............................57
Annex H (normative) Establishing endoscope type test groups............................................................................................63
Annex I (informative) Establishing endoscope product families..........................................................................................76
Bibliography.............................................................................................................................................................................................................................. 80

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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 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
iTeh STANDARD PREVIEW
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www​.iso​
.org/iso/foreword​.html. (standards.iteh.ai)
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 15883-4:2018
This second edition cancels and replaces the first edition (ISO 15883-4:2008), which has been
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technically revised. The main changes compared to the previous edition are as follows:
ec422713bdeb/iso-15883-4-2018
— additional annexes for establishing endoscope type test groups and endoscope product families
have been included.
A list of all the 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.

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 ISO 15883-4:2018(E)


Introduction
This introduction is intended to be read in conjunction with the introduction to ISO 15883-1.
The washer-disinfectors specified in this document are intended to process devices that can be
immersed in water or aqueous solutions. For some devices this will require that, prior to processing,
relevant parts of the device are protected from immersion in accordance with the device manufacturer’s
operating instructions.
Fields of application within the scope of the ISO series 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.
Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883.
Safety requirements for washer-disinfectors are given in IEC 61010-2-040.
In respect of the potential adverse effects on the quality of water intended for human consumption
caused by the washer-disinfector and its intended use, it is noteworthy that:
a) until verifiable international criteria are adopted, the existing national regulations concerning the
use and/or characteristics of the washer-disinfectors remain in force, and
b) the ISO 15883 series provides no information as to whether the washer-disinfectors can be used
iTeh STANDARD PREVIEW
without restriction in any of the ISO member states.

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INTERNATIONAL STANDARD ISO 15883-4:2018(E)

Washer-disinfectors —
Part 4:
Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes

1 Scope
This document specifies the particular requirements, including performance criteria for washer-
disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile
endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the
washer-disinfector and its components and accessories which can be required to achieve the necessary
performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation
(installation, operational and performance qualification on first installation), routine control and
monitoring, and requalification of WD periodically and after essential repairs, are also specified.
iTeh STANDARD PREVIEW
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of
(standards.iteh.ai)
activities covered by this document.

NOTE 2 WD complying with this document ISOcan also be used for cleaning and chemical disinfection of other
15883-4:2018
thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this
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method of disinfection.
ec422713bdeb/iso-15883-4-2018
WD complying with the requirements of this document are not intended for cleaning and disinfection
of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or
sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).
The specified performance requirements of this document do not ensure the inactivation or removal of
the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 3 If it is considered that prion protein might 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 and/or
other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.

NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement
on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

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 14971, Medical devices — Application of risk management to medical devices
ISO 15883-1:2006+Amd 1:2014, Washer-disinfectors — Part 1: General requirements, terms and definitions
and tests
ISO/TS 15883-5:2005, Washer-disinfectors — Part 5: Test soils and methods for demonstrating cleaning
efficacy

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IEC 61010-2-040, 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
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the
determination of bactericidal (including Legionella), mycobactericidal, sporicidal, fungicidal and virucidal
(including bacteriophages) activity
EN 13727, Chemical disinfectants and antiseptics — Quantitative suspension test for the evaluation of
bactericidal activity in the medical area — Test method and requirements (phase 2, step 1)

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following 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
air break
physical separation in water supply pipes to prevent back flow from equipment
[SOURCE: ISO 11139:2018, 3.8] iTeh STANDARD PREVIEW
3.2 (standards.iteh.ai)
analyte
chemical substance that is the subject of chemical analysis
ISO 15883-4:2018
[SOURCE: ISO 11139:2018, 3.12]
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ec422713bdeb/iso-15883-4-2018
3.3
block
<endoscope> group of channels comprising part of an endoscope with specified lengths, diameters and
interconnections
[SOURCE: ISO 11139:2018, 3.30]
3.4
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.

[SOURCE: ISO 11139:2018, 3.40]

3.5
colony forming unit
CFU
visible aggregation of microorganisms arising from a single cell or multiple cells
[SOURCE: ISO 11139:2018, 3.53]
3.6
disinfecting agent
physical or chemical agent used for disinfection
[SOURCE: ISO 11139:2018, 3.83]

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3.7
disinfection
process to inactivate viable microorganisms to a level previously specified as appropriate for a
defined purpose
[SOURCE: ISO 11139:2018, 3.84]
3.8
endoscope connector
device to interface with the fluid entry port of a channel of an endoscope that, where applicable, includes
the tubing connected to the channel irrigation system of the washer-disinfector
[SOURCE: ISO 11139:2018, 3.94]
3.9
endoscope leak test
set of actions to identify a loss of integrity
Note 1 to entry: The test is intended to establish that the surface covering the device and/or lining a device
channel is intact to the extent necessary to maintain a slightly positive pressure.

[SOURCE: ISO 11139:2018, 3.95, modified — Note 1 to entry has been added.]
3.10
endoscope port
part of an endoscope to which the irrigation system of the washer-disinfector is connected to irrigate
iTeh STANDARD PREVIEW
all or part of a channel
[SOURCE: ISO 11139:2018, 3.96](standards.iteh.ai)
3.11
ISO 15883-4:2018
endoscope product family
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group of endoscopes with comparable design, including the number, construction and purpose of the
ec422713bdeb/iso-15883-4-2018
different endoscope channels
[SOURCE: ISO 11139:2018, 3.97]
3.12
endoscope surrogate device
item designed to represent construction elements of endoscope specific characteristics affecting the
flow conditions in endoscope channels
Note 1 to entry: Elements can include channel length and diameter, connectors, channel separators, port closures,
return valves, etc.

[SOURCE: ISO 11139:2018, 3.98]

3.13
endoscope type test group
endoscopes for which the general channel design and specific characteristics affecting the flow
conditions in the endoscope are similar
Note 1 to entry: The general channel design includes lengths and diameters. Characteristics affecting the flow
conditions in the endoscope are, for example, connectors, channel separators, port closures, return valves.

Note 2 to entry: Similar implies that small variations can be possible. Endoscopes that show small variations in
channel specifications that do not lead to a significant variation in the flow and pressure characteristic through
the channels could be in the same endoscope type test group.

[SOURCE: ISO 11139:2018, 3.99]

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3.14
inoculated carrier
supporting material on or in which a specified number of viable test microorganisms has been deposited
[SOURCE: ISO 11139:2018, 3.144]
3.15
irrigation plan
<endoscope washer-disinfector> stipulated direction of flow of process fluids through the specified
channels of an endoscope
[SOURCE: ISO 11139:2018, 3.148]
3.16
liquid transport systems
<washer-disinfector> components of equipment used to store, pump or transport water and/or
solutions, excluding pipework before the air break
[SOURCE: ISO 11139:2018, 3.154]
3.17
microbial inactivation factor
measured change in microbial population caused by the lethal effect of the disinfection or
sterilization process
Note 1 to entry: It is expressed as log10.

[SOURCE: ISO 11139:2018, 3.173]

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3.18
(standards.iteh.ai)
microbial reduction factor ISO 15883-4:2018
extent to which the bioburden is reduced in tenfold increments
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Note 1 to entry: It is expressed as log10. ec422713bdeb/iso-15883-4-2018

Note 2 to entry: This can be caused by the combination of the microbial inactivation factor and the physical
removal of microorganisms.

[SOURCE: ISO 11139:2018, 3.174, modified — Note 2 to entry has been added.]
3.19
microbial resistance
ability of a microorganism or population of microorganisms to withstand a microbial reduction process
Note 1 to entry: This refers to resistance of microorganisms to disinfectants used in a WD.

[SOURCE: ISO 11139:2018, 3.175, modified — Note 1 to entry has been added.]
3.20
minimum effective concentration
MEC
lowest concentration of a chemical or product, used in a specified process, that achieves a claimed
activity
[SOURCE: ISO 11139:2018, 3.177]
3.21
minimum recommended concentration
MRC
lowest concentration of a chemical or product specified for use in a process
[SOURCE: ISO 11139:2018, 3.178]

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3.22
obstruction
<endoscope channel> partial or complete blockage
[SOURCE: ISO 11139:2018, 3.187]
3.23
port closure
<endoscope> device to close an endoscope port during processing in order to maintain the flow of
process fluids throughout the length of the endoscope
EXAMPLE To close the suction valve port.

[SOURCE: ISO 11139:2018, 3.198]

3.24
self-disinfection cycle
operating cycle intended to disinfect all liquid transport systems’ piping, chamber(s), tanks and other
components which come into contact with the water and/or solutions used for cleaning, disinfecting
and rinsing the load
Note 1 to entry: The self-disinfection cycle is used without a load in a washer-disinfector.

[SOURCE: ISO 11139:2018, 3.249]

3.25
thermolabile iTeh STANDARD PREVIEW
readily damaged by heat
(standards.iteh.ai)
[SOURCE: ISO 11139:2018, 3.302]
3.26 ISO 15883-4:2018
washer-disinfector accessory
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ec422713bdeb/iso-15883-4-2018
items or attachments, including connectors, required to process a medical device in a washer-disinfector
[SOURCE: ISO 11139:2018, 3.320]

4 Performance requirements

4.1 General

4.1.1 The WD shall conform to ISO 15883-1:2006+Amd 1:2014 with the exception of the following
subclauses:

a) 4.2.3 (washing stage, modified by 4.3.3 of this document);

b) 4.3.1 (specification for thermal disinfection of the load carrier and chamber walls during a standard
cleaning and disinfection cycle is not applicable to this document);
c) 4.3.3 (chemical and thermal disinfection, modified by 5.4 of this document);
d) 5.3.2.5 (microbial quality of final rinse water, modified by 4.5 of this document);
e) 5.11.4 (process verification, modified by 5.6 of this document);
f) 6.4.2.1 (test for quality of final rinse water – sampling, modified by 6.3 and Annex E of this
document);
g) 6.5.6 (test for chamber venting to prevent pressurization by steam is not applicable to this
document);

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ISO 15883-4:2018(E)


h) 6.8.2 (load temperature test, modified by 6.9.1 of this document);

i) 6.8.3 (chamber wall temperature test, replaced by 6.9.1 of this document);
j) 6.10.2 (cleaning efficacy test 1; modified by 6.11 of this document).
Means shall be provided to position temperature sensors for test purposes. Depending on the type of
washer design the manufacturer can decide to follow ISO 15883-1:2006+Amd 1:2014, 5.1.11 or provide
an alternative solution better fit to the purpose.

4.1.2 Each device, including any device channels and/or cavities, shall be processed by the WD as
follows:

a) leak testing (where appropriate) in accordance with 4.2;

b) cleaning (which may include several stages) in accordance with 4.3;
c) disinfecting in accordance with 4.4;
d) final rinsing in accordance with 4.5;
e) purging of rinse water in accordance with 4.6;
f) drying (when appropriate) in accordance with 4.7.

4.1.3 After the complete process in the WD the endoscope shall be safe for its intended use. The
iTeh STANDARD PREVIEW
combination of the cleaning, disinfection and rinsing process shall be designed to achieve this condition,
recognizing the high level of microbial and other contamination that might exist, see References [33],
(standards.iteh.ai)
[34] and [35]. It shall be necessary to take into account other factors such as the design of connectors.
This capability shall be demonstrated during type testing for endoscopes that the WD is designed to
process [see also 8 a), 8 b) and 8 c)]. ISO 15883-4:2018
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Where the disinfection of the water supplied to the WD is performed by adding a low dosage of a
ec422713bdeb/iso-15883-4-2018
disinfectant to the water, compliance with this document shall be demonstrated with and without
the water disinfectant. Any variation in water disinfectant concentration due to local environmental
conditions that might change the result of the test shall be taken into account.
Demonstration of the capability of the complete cycle efficacy shall be provided during additional type
testing by employing a modification of the methods described in Annex B with added test soil and/or
ISO/TS 15883-5:2005, Annex I, using the organism(s) previously established during in vitro tests as
most resistant to the disinfectant under in-use conditions and on endoscopes that are representative
for each relevant endoscope type test group [see 8 a) and Annex H].
According to the nature of the most resistant microorganism selected the minimum log10 reduction
obtained after a complete standard cycle for that microorganism(s) shall be:
— 9 log10 for vegetative bacteria;
— 6 log10 for fungal spores;
— 6 log10 for mycobacteria; or
— 4 log10 for bacterial endospores.
NOTE 1 In order to limit the work load the type tests can be performed on representative endoscopes from
endoscope type test groups (see Annex H to establish relevant endoscope type test groups).

NOTE 2 The efficacy of the process (including cleaning and disinfection) depends on a number of factors which
include:

a) the nature (characteristics) of the device being processed;

b) the extent and nature of the soiling to be removed;

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 ISO 15883-4:2018(E)


c) the temperature of the process;

d) the mechanical energy (type, output);

e) purging to remove rinse water;

f) the detergent system;

g) the nature, volume, concentration and temperature of the cleaning and disinfectant solutions and their
ability to wet the surfaces to be cleaned and disinfected;

h) the duration of the various process stages;

i) the removal of suspended soil.

4.1.4 The instructions for use of the WD shall recommend that the actions necessary to ensure effective
and safe processing of the endoscope and its accessories in the WD be followed, e.g. leak testing, any pre-
treatment, manual cleaning and/or disassembly, of the endoscope [see 8 k) 8)].

It shall be specified, which of the pre-treatment steps, as listed in the endoscope manufacturer’s
processing instructions for use, shall be performed in order to ensure effective and safe processing of
the endoscope.
NOTE National guidelines can require certain pre-cleaning steps (e.g. brushing of endoscopes channels prior
to processing inside WD).

4.1.5 The value of any process variable that affects the efficacy of the cycle shall be pre-set and
iTeh STANDARD PREVIEW
adjustment shall require the use of a key, code or tool (see also ISO 15883-1:2006+Amd 1:2014, 5.18.3,
5.18.8 and 5.18.12). (standards.iteh.ai)
4.1.6 The means to control the total ISO volume of water admitted per stage shall be controlled to a
15883-4:2018
manufacturer defined level of accuracy.
https://standards.iteh.ai/catalog/standards/sist/c163b2ed-a56b-446b-9506-
ec422713bdeb/iso-15883-4-2018
4.1.7 The means to control the volume of process chemicals admitted shall deliver the set volume to an
accuracy of ± 5 % or better.

4.1.8 When the WD uses two or more different process chemicals, means other than labelling and/or
colour coding alone of connectors, containers and/or tubing, shall be provided to ensure that connection
is made to the correct container of process chemical.

4.1.9 The instructions for use of the WD shall include a recommendation that heat-stable endoscopic
accessories for thermolabile medical devices should be thermally disinfected and/or sterilized.

4.1.10 The design of the washer-disinfector or any device or washer-disinfector accessories provided
with the WD shall not impair the quality of the water supplying the WD.

4.2 Systems for leak testing

4.2.1 These requirements shall apply only to WD intended to process endoscopes that require a test to
verify that the device is watertight.
NOTE This test is intended to demonstrate that the endoscope will not be damaged by liquid ingress during
the WD operating cycle. It is regarded only as a test of the integrity of the endoscope when all parameters of
the WD leak test (e.g. pressure, duration, maximum leak accepted) are consistent with those specified for the
endoscope.

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