SIST EN ISO 15883-4:2009

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance. 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 re-validation, periodically and after essential repairs, are also specified. This part of ISO 15883 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users.

Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope (ISO 15883-4:2008)

Dieser Teil von ISO 15883 legt die besonderen Anforderungen an Reinigungs-Desinfektionsgeräte (RDG)
einschließlich der Leistung fest, die für das Reinigen und die chemische Desinfektion von thermolabilen
Endoskopen vorgesehen sind.
Dieser Teil von ISO 15883 legt außerdem die Leistungsanforderungen an das Reinigen und die Desinfektion
des Reinigungs-Desinfektionsgeräts sowie von dessen Bauteilen und Zubehör fest, die zum Erreichen der
erforderlichen Leistung erforderlich sein können.
Des Weiteren sind die Verfahren, Ausrüstung und Anweisungen festgelegt, die für die Typprüfung,
Werksprüfung, Validierung (Installation, Betriebs- und Leistungsbeurteilung nach erstmaliger Installation),
Routinekontrolle und Überwachung sowie die regelmäßig und nach größeren Reparaturen durchzuführende
Revalidierung erforderlich sind.
ANMERKUNG 1 Zusätzlich gibt Anhang A einen Leitfaden für eine geeignete Aufteilung der Verantwortlichkeiten für die
in diesem Teil der ISO 15883 erfassten Tätigkeiten.
ANMERKUNG 2 RDG, die diesem Teil von ISO 15883 entsprechen, können auch zum Reinigen und zur chemischen
Desinfektion von anderen thermolabilen und wiederverwendbaren medizinischen Geräten verwendet werden, bei denen
der Hersteller der Geräte dieses Desinfektionsverfahren empfohlen hat.
RDG, die den Anforderungen dieses Teils von ISO 15883 entsprechen, sind nicht zum Reinigen und
Desinfizieren medizinischer Geräte, einschließlich endoskopischen Zubehörs, vorgesehen, die hitzebeständig
sind und durch thermische Verfahren (siehe ISO 15883-1:2006, 4.1.5) desinfiziert oder sterilisiert werden
können.
Es ist möglich, dass die in diesem Teil von ISO 15883 festgelegten Leistungsanforderungen nicht die
Inaktivierung oder die Beseitigung des (der) verursachenden Agens (Agenzien) (Prionenproteine) von
transmissiblen spongiformen Enzephalopathien sicherstellen.

Laveurs désinfecteurs - Partie 4: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2008)

L'ISO 15883-4:2008 spécifie les exigences particulières, notamment les performances, relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique des endoscopes thermosensibles.
L'ISO 15883-4:2008 spécifie également les exigences de performance relatives au nettoyage et à la désinfection du laveur désinfecteur ainsi que de ses composants et accessoires qui peuvent être nécessaires pour atteindre les performances voulues.
Les méthodes, l'instrumentation et les instructions nécessaires pour les essais de type, de fonctionnement, la validation (qualification opérationnelle de l'installation et des performances lors de la première installation), le contrôle de routine, la surveillance et la revalidation, réalisés périodiquement et après des réparations essentielles, sont également spécifiés.
L'ISO 15883-4:2008 peut être utilisée par des fabricants ou des acheteurs potentiels comme une base d'accord entre les spécifications des fabricants d'endoscopes, de produits de nettoyage et de produits désinfectants. Elle peut également être exploitée par les utilisateurs.

Čistilno-dezinfekcijske naprave - 4. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s kemično dezinfekcijo za termolabilne endoskope (ISO 15883-4:2008)

General Information

• Status: Withdrawn
• Public Enquiry End Date: 09-Apr-2009
• Publication Date: 17-Aug-2009
• Withdrawal Date: 03-Feb-2019
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Feb-2019
• Due Date: 24-Feb-2019
• Completion Date: 04-Feb-2019
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 15883-4:2009 - Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)

Relations

• Replaced By: SIST EN ISO 15883-4:2019 - Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
• Effective Date: 01-Mar-2019
• Replaces: SIST EN ISO 15883-4:2008 - Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
• Effective Date: 01-Sep-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15883-4:2009
01-september-2009
1DGRPHãþD
SIST EN ISO 15883-4:2008
ýLVWLOQRGH]LQIHNFLMVNHQDSUDYHGHO=DKWHYHLQSUHVNXVL]DþLVWLOQR
GH]LQIHNFLMVNHQDSUDYHVNHPLþQRGH]LQIHNFLMR]DWHUPRODELOQHHQGRVNRSH,62

Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für thermolabile Endoskope
(ISO 15883-4:2008)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection chimique des endoscopes thermolabiles (ISO 15883-4:2008)
Ta slovenski standard je istoveten z: EN ISO 15883-4:2009
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN ISO 15883-4:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15883-4:2009

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SIST EN ISO 15883-4:2009
EUROPEAN STANDARD
EN ISO 15883-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.10 Supersedes EN ISO 15883-4:2008
English Version
Washer-disinfectors - Part 4: Requirements and tests for
washer-disinfectors employing chemical disinfection for
thermolabile endoscopes (ISO 15883-4:2008)
Laveurs désinfecteurs - Partie 4: Exigences et essais pour Reinigungs-Desinfektionsgeräte - Teil 4: Anforderungen
les laveurs désinfecteurs destinés à la désinfection und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit
chimique des endoscopes thermolabiles (ISO 15883- chemischer Desinfektion für thermolabile Endoskope (ISO
4:2008) 15883-4:2008)
This European Standard was approved by CEN on 16 May 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-4:2009: E
worldwide for CEN national Members.

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SIST EN ISO 15883-4:2009
EN ISO 15883-4:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 15883-4:2009
EN ISO 15883-4:2009 (E)
Foreword
The text of ISO 15883-4:2008 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
15883-4:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” 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 December 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15883-4:2008.
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 EC Directive.
For relationship with EC Directive, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15883-4:2008 has been approved by CEN as a EN ISO 15883-4:2009 without any
modification.
3

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SIST EN ISO 15883-4:2009
EN ISO 15883-4:2009 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical
devices
Clauses/subclauses of Essential requirements (ERs) of EU Qualifying remarks/Notes
this International Directive 93/42/EEC
Standard
4.1.1
1, 2, 3, 4, 5, 6, 7.1, 7.2, 7.3, 7.5, 7.6, 8.1, 9.1, The WD shall comply with the
9.2, 9.3, 12.1, 12.5, 12.6, 12.7.1, 12.7.3, 12.7.5, requirements of ISO 15883-
13.1, 13.3, 13.4, 13.6 1:2006
4.1.2
1, 3, 4, 6, 7.1, 7.2, 7.5, 8.1, 9.1
4.1.3 1, 3, 4, 6, 7.1,7.2, 7.5, 8.1, 9.1
4.1.4 13.3 i), 13.3 k)
4.1.5 7.3, 8.1
4.1.6 7.3, 8.1
3, 7.3, 8.1, 9.1
4.1.7
4.1.8
13.4, 13.6 h), 13.3 k), 13.3 m)
4.2 3, 7.3, 7.5, 7.6, 8.1
4.3 3, 8.1
4.4 3, 8.1
4.5 3, 8.1
4.6 3, 8.1
4.7 3, 8.1
4.8
3, 9.1, 9.2
4.9 13.1, 13.6 d)
5.1
3, 9.1, 12.7.5

4

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SIST EN ISO 15883-4:2009
EN ISO 15883-4:2009 (E)

Table ZA.1 (continued)
Clauses/subclauses of this Essential requirements (ERs) Qualifying remarks/Notes
European Standard of EU Directive 93/42/EEC
5.2 3, 8.1, 13.1
5.3 7.2, 7.5, 8.1
5.4 3, 8.1
5.5 3, 8.1
5.6 2, 3
6.2 1, 2, 3, 6, 7.1, 8.1 Testing for conformity
6.3 3, 9.1 Testing for conformity
6.4 3, 7.3, 8.1, 9.1 Testing for conformity
6.5 3, 7.5, 8.1, 9.1 Testing for conformity
6.6 3, 7.5, 8.1 Testing for conformity
6.7 3, 8.1 Testing for conformity
6.8 3, 8.1 Testing for conformity
6.9 3, 8.1 Testing for conformity
6.10 3, 8.1 Testing for conformity
6.11 3, 8.1 Testing for conformity
6.12 3, 8.1
7 13 The requirements of ISO 15883-1:2006
apply.
8 13.1, 13.3, 13.4, 13.6 In addition, the requirements of
ISO 15883-1:2006 apply.
9 5, 13 The requirements of ISO 15883-1:2006
apply.
10 1, 3 In addition, the requirements of
ISO 15883-1:2006 apply.
- 12.1a) This relevant Essential Requirement is
not addressed in this European
Standard
7, 8, 9 13.3 a) This relevant Essential Requirement is
partly addressed in this European
Standard
- 13.6 q) This relevant Essential Requirement is
not addressed in this European
Standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
5

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SIST EN ISO 15883-4:2009
EN ISO 15883-4:2009 (E)
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)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
4.1.1 1.1.7, 1.2.2, 1.2.3, 1.2.4, 1.2.5, 1.3.2, This relevant EHSR are
1.3.3, 1.3.4, 1.5.1, 1.5.2, 1.5.3, 1.5.5, addressed in this Standard
1.5.6, 1.5.8, 1.5.13, 1.5.14, 1.6.2,
1.6.3, 1.6.4, 1.6.5
4.1.1 1.1.3, 1.1.5, 1.1.6, 1.2.1, 1.2.6, 1.3.1, This relevant EHSR are partly
1.3.7, 1.3.8.1, 1.3.8.2, 1.5.4, 1.6.1, addressed in this Standard
1.7.1, 1.7.2, ,1.7.3, 1.7.4
1.3.9, 1.4.1, 1.4.2, 1.4.3, 1.5.9, 4 This relevant EHSR are not
addressed in this Standard

6

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SIST EN ISO 15883-4:2009

INTERNATIONAL ISO
STANDARD 15883-4
First edition
2008-05-01


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 15883-4:2008(E)
©
ISO 2008

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SIST EN ISO 15883-4:2009
ISO 15883-4:2008(E)
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ii © ISO 2008 – All rights reserved

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SIST EN ISO 15883-4:2009
ISO 15883-4:2008(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Performance requirements . 3
4.1 General. 3
4.2 Systems for leak testing . 4
4.3 Cleaning. 6
4.4 Disinfecting . 7
4.5 Final (post-disinfection) rinsing . 9
4.6 Purging to remove rinse water. 9
4.7 Drying. 9
4.8 Self-disinfection. 10
4.9 Water treatment equipment . 11
5 Mechanical and process requirements . 12
5.1 Materials ― Design, manufacture and construction. 12
5.2 Device channel irrigation system. 12
5.3 Venting and drainage systems. 13
5.4 Temperature control. 14
5.5 Process chemicals. 14
5.6 Process verification. 14
5.7 Dosing systems . 14
6 Testing for conformity. 14
6.1 General. 14
6.2 Test equipment . 15
6.3 Water used for final (post-disinfection) rinsing. 15
6.4 Hardness of water used during type testing. 15
6.5 Leak test . 16
6.6 Channels non-obstruction test. 18
6.7 Channels non-connection test . 19
6.8 Load dryness. 20
6.9 Thermometric tests. 20
6.10 Chemical dosing tests. 21
6.11 Tests of cleaning efficacy . 22
6.12 Test of disinfection efficacy . 23
7 Documentation and inspection . 27
8 Information to be supplied by the manufacturer. 27
9 Marking, labelling and packaging . 28
10 Information to be requested from the purchaser by the manufacturer . 28
Annex A (informative) Summary of activities covered by this Part of ISO 15883. 29
Annex B (normative) Microbiological testing of the efficacy of chemical disinfection of the load. 31
Annex C (informative) Summary of test programmes . 34
Annex D (normative) Methods for microbiological evaluation of disinfection of liquid transport
system. 35
© ISO 2008 – All rights reserved iii

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SIST EN ISO 15883-4:2009
ISO 15883-4:2008(E)
Annex E (normative) Tests for microbial contamination of post-disinfection rinse water. 40
Annex F (informative) Typical specifications of trumpet valves and connection ports. 41
Annex G (informative) Additional notes on microbiological testing of chemical disinfection
processes. 46
Bibliography . 48

iv © ISO 2008 – All rights reserved

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SIST EN ISO 15883-4:2009
ISO 15883-4:2008(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 15883-4 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 15883 consists of the following parts, under the general title Washer-disinfectors:
⎯ Part 1: General requirements, terms and definitions and tests
⎯ Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
⎯ Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste
containers
⎯ Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile
endoscopes
⎯ Part 5: Test soils and methods for demonstrating cleaning efficacy
© ISO 2008 – All rights reserved v

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SIST EN ISO 15883-4:2009
ISO 15883-4:2008(E)
Introduction
It is recommended that this introduction be read in conjunction with the introduction to ISO 15883-1.
The washer-disinfectors specified in this part of ISO 15883 are intended to process devices which 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 15883 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.
With respect to the potential adverse effects on the quality of water intended for human consumption caused
by the washer-disinfectors:
a) note that, until verifiable European criteria are adopted, existing national regulations concerning the use
and/or the characteristics of the washer-disinfectors remain in force;
b) this part of ISO 15883 provides no information as to whether the washer-disinfectors may be used without
restriction in any of the member states of the EU or EFTA.

vi © ISO 2008 – All rights reserved

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SIST EN ISO 15883-4:2009
INTERNATIONAL STANDARD ISO 15883-4:2008(E)

Washer-disinfectors —
Part 4:
Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes
1 Scope
This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors
(WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.
This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the
washer-disinfector and its components and accessories which may be required to achieve the necessary
performance.
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 re-validation,
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 part of ISO 15883.
NOTE 2 WDs complying with this part of ISO 15883 can also be used for cleaning and chemical disinfection of other
thermolabile re-usable medical devices for which the device manufacturer has recommended this method of disinfection.
WDs complying with the requirements of this part of ISO 15883 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, 4.1.5).
The specified performance requirements of this part of ISO 15883 may 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 disinfectants
and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its
removal or inactivation from the load or washer-disinfector.
This part of ISO 15883 can be used by prospective purchasers and manufacturers as the basis of agreement
on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also
by users.
© ISO 2008 – All rights reserved 1

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SIST EN ISO 15883-4:2009
ISO 15883-4:2008(E)
2 Normative references
The following referenced documents are indispensable for the application 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 11731-2, Water quality — Detection and enumeration of Legionella — Part 2: Direct membrane filtration
method for waters with low bacterial counts
ISO 15883-1:2006, 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
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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following apply.
3.1
air break
physical separation in water supply pipes to prevent back syphonage into the water supply from a device
connected to it
NOTE See EN 1717.
3.2
inoculated carrier
supporting material on or in which a defined number of viable test organisms has been deposited
[ISO 11138-1:2006, definition 3.10]
3.3
leak test
test 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
3.4
liquid transport systems
those components of the washer-disinfector used to store, pump or transport water and/or solutions within the
washer-disinfector, excluding pipework before the air break
3.5
microbial inactivation factor
measured change in microbial population, expressed as log , caused by the lethal effect of the disinfectant
10
3.6
microbial reduction factor
measured change in microbial population expressed as log caused by the combination of the microbial
10
inactivation factor and the physical removal of microorganisms
3.7
obstruction
partial or complete blockage
2 © ISO 2008 – All rights reserved

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SIST EN ISO 15883-4:2009
ISO 15883-4:2008(E)
3.8
self-disinfection cycle
operating cycle under the control of the automatic controller, for use without any load in the washer-disinfector,
which is 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 This does not include disinfection of any pipework between the disinfectant supply and the control valve,
where single-use, multi-dose containers are used to provide process chemicals for use in the washer-disinfector.
3.9
thermolabile
damaged by exposure to temperatures within the range used for thermal disinfection
NOTE The minimum temperature for thermal disinfection specified in ISO 15883-1 is 65 °C.
4 Performance requirements
4.1 General
4.1.1 The WD shall conform to ISO 15883-1:2006 with the exception of the following subclauses:
⎯ 4.2.3 (washing stage);
⎯ 4.3.1 (specification for thermal disinfection);
⎯ 5.3.2.5 (microbial quality of final rinse water);
⎯ 6.4.2 (test for quality of final rinse water);
⎯ 6.5.6 (test for chamber venting to prevent pressurization by steam);
⎯ 6.7.2 (tests on trolleys for handling loads outside the WD);
⎯ 6.8.2 (load temperature test);
⎯ 6.10 (cleaning efficacy test; 6.10.2 modified by 6.11 of this part of ISO 15883).
NOTE These subclauses have been replaced or modified in this part of ISO 15883.
4.1.2 Each device, including any device channels and/or cavities, shall be processed by the WD
...