EN ISO 15883-4:2018

SLOVENSKI STANDARD
01-marec-2019
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SIST EN ISO 15883-4:2009
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Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope
(ISO 15883-4:2018)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour les laveurs désinfecteurs
destinés à la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2018)
Ta slovenski standard je istoveten z: EN ISO 15883-4:2018
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-4
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2018
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-4:2009
English Version
Washer-disinfectors - Part 4: Requirements and tests for
washer-disinfectors employing chemical disinfection for
thermolabile endoscopes (ISO 15883-4:2018)
Laveurs désinfecteurs - Partie 4: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 4:
pour les laveurs désinfecteurs destinés à la Anforderungen und Prüfverfahren für Reinigungs-
désinfection chimique des endoscopes thermolabiles Desinfektionsgeräte mit chemischer Desinfektion für
(ISO 15883-4:2018) thermolabile Endoskope (ISO 15883-4:2018)
This European Standard was approved by CEN on 17 August 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 15883-4:2018 E
worldwide for CEN national Members.

Contents
Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .5

European foreword
This document (EN ISO 15883-4:2018) 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 June 2019, and conflicting national standards shall be withdrawn at
the latest by June 2020.
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.
This document supersedes EN ISO 15883-4:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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.
The following referenced documents are indispensable for the application of this document. For undated
references, the latest edition of the referenced document (including any amendments) applies. For dated
references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex
ZA’, the user should always check that any referenced document has not been superseded and that its
relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the
ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO

standard
EN ISO
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
ISO 15883-1 EN ISO 15883-1:2009 + A1:2014 ISO 15883-1:2006 + Amd1:2014
ISO/TS 15883-5 CEN/ISO/TS 15883-5:2005 ISO TS 15883-5:2005
IEC 61010-2-040 EN 61010-2-040:2015 IEC 61010-2-040:2015
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
standard
EN ISO
EN 12353 EN 12353:2013 --
EN 13727 EN 13727:2013+A2:2015 --

Endorsement notice
The text of ISO 15883-4:2018 has been approved by CEN as EN ISO 15883-4:2018 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s mandate M/023 concerning the
development of European Standards related to medical devices to provide one voluntary means of conforming
to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [OJ L
169].
Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with
the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this
standard, a presumption of conformity with the corresponding essential requirements of that Directive and
associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential Requirements
1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Directive 93/42/EEC [OJ L 169]
Clause(s)/sub-clause(s) of this Remarks/Notes
Essential
EN
Requirements of
Directive 93/42/EEC
st
7.3, 1 part only 4.9.2 Covered only in respect of
disinfection of the incoming
water treatment equipment.
Aspects related to manufacturing
are not covered
7.6 4.6.2, 4.9.2.3 Standard clause 4.6.2 covers ER
7.6 for the ingress of oil and
particles, standard clause
4.9.2.3 for the ingress of
microbes into the endoscopes
being processed only. Aspects
related to manufacturing are not
covered.
Clause(s)/sub-clause(s) of this Remarks/Notes
Essential
EN
Requirements of
Directive 93/42/EEC
8.1 4.1.2, 4.1.3, 4.1.5, 4.1.6, 4.1.7, Covered only in respect of
4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8,
preventing patient and user
4.9, 5.2, 5.3, 5.4, 5.5
infection by the effective
reprocessing of endoscopes.
Aspects related to manufacturing
are not covered.
The last sentence of ER 8.1 is
not covered.
9.1 4.1.2, 4.1.3, 4.1.7, 4.1.8, 4.2.4,
Covered only in respect of
4.8, 4.9, 5.1, 5.2
preventing patient cross infection
by the effective reprocessing of
endoscopes.
The last sentence of ER 9.1 is
not covered.
13.6 a) 8 k) Covered for the information
required in ER 13.3 j)
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European Standard
is maintained in the list published in the Official Journal of the European Union. Users of this standard should
consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant
essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific
than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table
ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not
provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Essential Health and Safety Clause(s)/sub-clause(s) of this Remarks/Notes
Requirements (EHSRs) of EN
Directive 2006/42/EC
nd
1.2.1, 2 dash 4.2.3, 4.2.4, 4.4.4, 4.8.4 Covered in respect of leak
detection and process
monitoring during endoscope
processing and self-disinfection
procedure.
Essential Health and Safety Clause(s)/sub-clause(s) of this Remarks/Notes
Requirements (EHSRs) of EN
Directive 2006/42/EC
1.5.4 4.1.8, 4.2.4 a), 4.2.4 b), 8
Standard clause 4.1.8 and
4.2.4a), 4.2.4 b) cover EHSR
1.5.4 in respect of connections
for process chemicals and
connection systems between the
WD and the endoscope only.
Standard clause 8 covers EHSR
1.5.4 second paragraph only.
1.6.5 4.8, 4.9 Standard clause 4.8 covers
EHSR 1.6.5 with respect to
requiring a self-disinfection
cycle, clause 4.9 to requiring a
procedure for disinfection of the
water treatment equipment to be
provided.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European Standard
is maintained in the list published in the Official Journal of the European Union. Users of this standard should
consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
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
Laveurs désinfecteurs —
Partie 4: Exigences et essais pour les laveurs désinfecteurs destinés à
la désinfection chimique des endoscopes thermolabiles
Reference number
ISO 15883-4:2018(E)
©
ISO 2018
ISO 15883-4:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 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
4.4.5 Disinfectant use .11
4.5 Final rinsing .12
4.6 Purging to remove rinse water .12
4.7 Drying .13
4.8 Self-disinfection .13
4.9 Water treatment equipment.14
4.9.1 General.14
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
ISO 15883-4:2018(E)
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
6.8.4 Channel drying .27
6.9 Thermometric tests .27
6.9.1 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 .28
6.10 Chemical dosing tests for single-dose containers .28
6.10.1 Principle .28
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
iv © ISO 2018 – All rights reserved

ISO 15883-4:2018(E)
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
ISO 15883-4:2018(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 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 15883-4:2008), which has been
technically revised. The main changes compared to the previous edition are as follows:
— 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.
vi © ISO 2018 – All rights reserved

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
without restriction in any of the ISO member states.
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.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of
activities covered by this document.
NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other
thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this
method of disinfection.
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
ISO 15883-4:2018(E)
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]
3.2
analyte
chemical substance that is the subject of chemical analysis
[SOURCE: ISO 11139:2018, 3.12]
3.3
block
group of channels comprising part of an endoscope with specified lengths, diameters and
interconnections
[SOURCE: ISO 11139:2018, 3.30]
3.4
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.
[SOURCE: ISO 11139:2018, 3.40]
3.5
colo
...