EN ISO 15883-7:2025
(Main)Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025)
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025)
This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as:
a) bed frames;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs;
i) aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications to be carried out periodically and after essential repairs.
NOTE 1 WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2 The performance requirements specified in this document cannot ensure the inactivation or removal of the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-7:2025)
Dieses Dokument legt die Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für das Reinigen und die chemische Desinfektion von wiederverwendbaren Produkten/Gegenständen in einem einzigen Betriebszyklus vorgesehen sind, zum Beispiel:
a) Bettgestelle;
b) Nachttische;
c) Transportwagen;
d) Container;
e) OP-Tische;
f) Sterilisationsbehälter;
g) OP-Schuhe;
h) Rollstühle;
i) Hilfen für Menschen mit Behinderungen.
Dieses Dokument legt außerdem die Leistungsanforderungen an die Reinigung und Desinfektion des RDG sowie von dessen Bauteilen und Zubehör fest.
Geräte, die in den Anwendungsbereich von ISO 15883 2, ISO 15883 3, ISO 15883 4 und ISO 15883 6 fallen, sind nicht im Anwendungsbereich dieses Dokuments erfasst.
Des Weiteren sind in diesem Dokument die Verfahren für die Typprüfung, Werksprüfung, Validierung (Installations-, Funktions- und Leistungsqualifizierung nach erstmaliger Installation), Routinekontrolle und Überwachung sowie die regelmäßig und nach größeren Reparaturen durchzuführenden Requalifizierungen festgelegt.
ANMERKUNG 1 RDG, die in diesem Dokument behandelt werden, können auch zum Reinigen und zur chemischen Desinfektion von anderen thermolabilen und wiederverwendbaren Geräten verwendet werden, wenn dies in der Gebrauchsanweisung für diese Geräte empfohlen wird.
ANMERKUNG 2 Die in diesem Dokument festgelegten Leistungsanforderungen können die Inaktivierung oder die Beseitigung des (der) verursachenden Agens (Agenzien) (Prionenproteine) von transmissiblen spongiformen Enzephalopathien nicht sicherstellen.
Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des dispositifs médicaux thermosensibles non critiques et des équipements de soins de santé (ISO 15883-7:2025)
Le présent document spécifie les exigences relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique, au cours d’un seul cycle de fonctionnement, d’articles réutilisables tels que:
a) les cadres de lit;
b) les tables de chevet;
c) les chariots de transport;
d) les récipients;
e) les tables d’opération;
f) les récipients de stérilisation;
g) les sabots médicaux;
h) les fauteuils roulants;
i) les aides pour les personnes handicapées.
Le présent document spécifie également les exigences de performance relatives au nettoyage et à la désinfection du LD ainsi que de ses composants et accessoires.
Les dispositifs identifiés dans les domaines d’application de l’ISO 15883-2, l’ISO 15883-3, l’ISO I5883‑4 et l’ISO 15883-6 ne relèvent pas du domaine d’application du présent document.
Le présent document spécifie également les méthodes pour les essais de type, les essais de fonctionnement, la validation (qualification de l’installation, qualification opérationnelle et qualification des performances lors de la première installation), le contrôle de routine et la surveillance, de même que les requalifications à effectuer périodiquement et après des réparations importantes.
NOTE 1 Les LD couverts par le présent document peuvent également être utilisés pour le nettoyage et la désinfection chimique d’autres dispositifs thermosensibles réutilisables, selon les recommandations figurant dans les instructions d’utilisation de ces dispositifs.
NOTE 2 Les exigences de performance spécifiées dans le présent document ne peuvent pas assurer l’inactivation ou l’élimination du ou des agents infectieux (protéines du prion) des encéphalopathies spongiformes transmissibles.
Čistilno-dezinfekcijske naprave - 7. del: Zahteve in preskusne metode za čistilno-dezinfekcijske naprave s kemično dezinfekcijo za nekritične termolabilne medicinske pripomočke in zdravstveno opremo (ISO 15883-7:2025)
Ta dokument določa zahteve za čistilno-dezinfekcijske naprave (WD), namenjene uporabi za čiščenje in kemično dezinfekcijo (v enem samem operativnem ciklu) predmetov za večkratno uporabo, kot so: a) posteljni okviri; b) nočne omarice; c) transportni vozički; d) vsebniki; e) kirurške mize; f) vsebniki za steriliziranje; g) kirurški natikači; h) invalidski vozički; i) pripomočki za invalidne osebe. Ta dokument določa tudi zahteve za učinkovitost čiščenja in dezinfekcije čistilno-dezinfekcijske naprave ter njenih sestavnih delov in dodatkov. Naprave, opredeljene v standardih ISO 15883-2, ISO 15883-3, ISO 15883-4 in ISO 15883-6, ne spadajo na področje uporabe tega dokumenta. Poleg tega ta dokument določa metode za tipsko preskušanje, preskušanje delovanja, validacijo (namestitev, delovanje in delovna ustreznost ob prvi namestitvi), rutinsko kontrolo in nadzor ter ponovno potrditev, ki jih je treba izvajati v intervalih ter po nujnih popravilih. OPOMBA 1: Čistilno-dezinfekcijske naprave, zajete v tem dokumentu, je mogoče uporabljati tudi za čiščenje in kemično dezinfekcijo drugih termolabilnih medicinskih pripomočkov za ponovno uporabo, v skladu s priporočili v navodilih za uporabo (IFU) za te pripomočke. OPOMBA 2: Zahteve za učinkovitost, določene v tem dokumentu, morda ne zagotavljajo inaktivacije ali odstranitve vzročnih povzročiteljev (prionskih beljakovin) prenosljivih spongiformnih encefalopatij.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Nadomešča:
SIST EN ISO 15883-7:2016
Čistilno-dezinfekcijske naprave - 7. del: Zahteve in preskusne metode za čistilno-
dezinfekcijske naprave s kemično dezinfekcijo za nekritične termolabilne
medicinske pripomočke in zdravstveno opremo (ISO 15883-7:2025)
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical devices and health care
equipment (ISO 15883-7:2025)
Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische
thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-7:2025)
Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs
destinés à la désinfection chimique des dispositifs médicaux thermosensibles non
critiques et des équipements de soins de santé (ISO 15883-7:2025)
Ta slovenski standard je istoveten z: EN ISO 15883-7:2025
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15883-7
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2025
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-7:2016
English Version
Washer-disinfectors - Part 7: Requirements and tests for
washer-disinfectors employing chemical disinfection for
non-critical thermolabile medical devices and health care
equipment (ISO 15883-7:2025)
Laveurs désinfecteurs - Partie 7: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 7:
pour les laveurs désinfecteurs destinés à la Anforderungen und Prüfverfahren für Reinigungs-
désinfection chimique des dispositifs médicaux Desinfektionsgeräte mit chemischer Desinfektion für
thermosensibles non critiques et des équipements de nicht kritische thermolabile Medizinprodukte und
soins de santé (ISO 15883-7:2025) Zubehör im Gesundheitswesen (ISO 15883-7:2025)
This European Standard was approved by CEN on 12 March 2025.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-7:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
This document (EN ISO 15883-7:2025) 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 November 2025, and conflicting national standards
shall be withdrawn at the latest by November 2025.
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 15883-7:2016.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15883-7:2025 has been approved by CEN as EN ISO 15883-7:2025 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745.
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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance 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
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up General Safety and Performance
Requirements of Regulation (EU) 2017/745
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/745
5(a) 4.1.3 The selected clause 4.1.3
partly covers the
requirement. Covered by
reduction of risks related to
damage the load during
operation.
Aspects related to the
environment in which the WD
is intended to be used are not
covered.
11.1 (d) 4.4, 4.7.2.3, 4.7.3 The selected clauses 4.4,
4.7.2.3, 4.7.3 partly covers
the requirement. Covered
with respect to preventing
microbial re-contamination
when using fluids for rinsing
process residue.
11.2 4.5 The selected clause 4.5 partly
covers the requirement.
Covered in respect of
preventing contamination of
the device.
14.2 (e) 4.7.2.3, 4.7.2.4 The selected clauses 4.7.2.3
and 4.7.2.4 partly cover the
requirement. Covered in
respect of avoiding
contamination of internal
piping.
18.8 4.1.4 The selected clause 4.1.4
partly covers the
requirement. Covered in
respect of unauthorized access
on the device.
23.4 (k) 8 a) – 8 j) Covered in respect of
documentation provided for
installation and safe operation
of the WD
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding
Clause 2 Standard Edition
European Standard
Edition
ISO 11139:2018 ISO 11139:2018 Sterilization of health care EN ISO 11139:2018
products — Vocabulary of terms
ISO ISO EN ISO
used in sterilization and related
11139:2018/Amd 11139:2018/Amd 11139:2018/A1:2024
equipment and process
1:2024 1:2024
standards
ISO 15883-1:2024 ISO 15883-1:2024 Washer-disinfectors — Part 1: EN ISO 15883-1:2025
General requirements, terms and
definitions and tests
ISO 15883-5:2021 ISO 15883-5:2021 Washer-disinfectors — Part 5: EN ISO 15883-5:2021
Performance requirements and
test method criteria for
demonstrating cleaning efficacy
IEC 61010-2- IEC 61010-2- Safety requirements for electrical EN IEC 61010-2-
040:2020 040:2020 equipment for measurement, 040:2021
control and laboratory use —
Part 2-040: Particular
requirements for sterilizers and
washer-disinfectors used to treat
medical materials
EN 10088-1 For applicable Stainless steels — Part 1: List of EN 10088-1:2023
standard edition see stainless steels
Column 4
EN 10088-2 For applicable Stainless steels — EN 10088-2:2024
standard edition see Part 2: Technical delivery
Column 4 conditions for sheet/plate and
strip of corrosion resisting steels
for general purposes
EN 12353:2021 For applicable Chemical disinfectants and EN 12353:2021
standard edition see antiseptics — Preservation of
Column 4 test organisms used for the
determination of bactericidal
(including Legionella),
mycobactericidal, sporicidal,
fungicidal and virucidal
(including bacteriophages)
activity
EN For applicable Chemical disinfectants and EN
13727:2012+A2:20 standard edition see antiseptics — Quantitative 13727:2012+A2:2015
15 Column 4 suspension test for the evaluation
of bactericidal activity in the
medical area — Test method and
requirements (phase 2, step 1)
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in Column 2 of Table ZA.2.
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 product(s) 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 1(12) of Regulation (EU) 2017/745, the following Table ZA.3
details the relevant Essential Health and Safety Requirements of Directive 2006/42/EC on Machinery to
the extent to which they are more specific than the General Safety and Performance Requirements set
out in Chapter II of Annex I of Regulation (EU) 2017/745 along with the corresponding clauses of this
European Standard. Table ZA.3, 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.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in the Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European Regulation for
medical devices (EU) 2017/745).
Table ZA.3 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this Document (according to article 1, item 12, of Regulation
(EU) 2017/745)
Essential Health and Safety
Clause(s) / sub-clause(s)
Requirements of Directive Remarks / Notes
of this EN
2006/42/EC
1.2.1 4.1.4, 4.1.5 The selected clauses 4.1.4 and
4.1.5 are partly covered in
respect of reliability of process
control systems (here chemical
dosing).
1.3.6 4.5, 5.2 The selected clause 4.5 is partly
covered in respect to self-
disinfection of the device and
clause 5.2 in respect to pre-set
the washing/disinfection
temperature and time to adapt
to different conditions and
clause.
1.6.4 4.1.2, 4.1.3 The selected clause 4.1.2 is
covered with respect to
authorized access for
adjustment of parameters and
clause 4.1.3 with respect of
avoiding of operator
intervention during loading the
WD.
1.6.5 4.5, 4.7.2.3 The selected clauses 4.5 and
4.7.2.3 are covered in respect
of self-cleaning and
disinfection during standard
operation.
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 product(s) falling within the scope of
this standard.
International
Standard
ISO 15883-7
Second edition
Washer-disinfectors —
2025-03
Part 7:
Requirements and tests for washer-
disinfectors employing chemical
disinfection for non-critical
thermolabile medical devices and
health care equipment
Laveurs désinfecteurs —
Partie 7: Exigences et essais pour les laveurs désinfecteurs
destinés à la désinfection chimique des dispositifs médicaux
thermosensibles non critiques et des équipements de soins de santé
Reference number
ISO 15883-7:2025(en) © ISO 2025
ISO 15883-7:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
ISO 15883-7:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Performance requirements . . 3
4.1 General .3
4.2 Cleaning .3
4.3 Disinfection .4
4.4 Final rinsing .5
4.5 Self-disinfection .5
4.6 Drying .6
4.7 Water treatment equipment .6
4.7.1 General .6
4.7.2 Disinfection of water treatment equipment .7
4.7.3 Maintenance of piping .7
5 Mechanical requirements . 8
5.1 Materials: design, manufacture, and assembly .8
5.2 Process verification .8
6 Testing for conformity . 8
6.1 General .8
6.2 Test load .8
6.2.1 Loading with standard goods .8
6.2.2 Loading with special goods .8
6.3 Final rinse water .8
6.4 Load dryness .9
6.4.1 General .9
6.4.2 Procedure .9
6.4.3 Results .9
6.5 Thermometric tests .9
6.5.1 General .9
6.5.2 Load temperature test . . .9
6.6 Chemical dosing tests .9
6.6.1 General .9
6.6.2 Reused process chemicals.9
6.7 Tests of cleaning efficacy .9
6.7.1 General .9
6.7.2 Materials .10
6.7.3 Procedure .10
6.7.4 Results .10
6.8 Test of disinfection efficacy .10
6.8.1 General .10
6.8.2 Preliminary tests on chemical disinfectants .11
6.8.3 Self-disinfection tests . 12
6.8.4 Chemical disinfection of the load . 12
7 Documentation .13
8 Information to be supplied .13
9 Marking, labelling, and packaging .13
10 Information to be requested from the purchaser by the WD supplier .13
Annex A (informative) Summary of test programmes . 14
iii
ISO 15883-7:2025(en)
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid transport
system.16
Annex C (normative) Tests for microbiological contamination of final rinse water .21
Annex D (normative) Preparation and evaluation of indicators for microbiological testing of
the efficacy of chemical disinfection of the load .22
Annex E (informative) Examples of test locations for the tests with biological indicators .26
Bibliography .30
iv
ISO 15883-7:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
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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, in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 102,
Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 15883-7:2016), which has been technically
revised.
The main changes are as follows:
— deletion of ‘non-invasive’ from the document title and within clauses;
— incorporation of requirements of and reference to ISO 15883-1:2024 and ISO 15883-5:2021;
— revision of cross-references to relevant clauses in ISO 15883-1:2024 and ISO 15883-5:2021;
— alignment with terms and definitions in ISO 11139:2018 and ISO 11139:2018/Amd1:2024;
— update of Introduction and addition of reference to ISO/TS 5111 on water quality;
— clarification on requirement for reused process chemicals (see 4.2.4 and 6.6.2);
— Annex A changed from normative to informative;
— updated Annex C method description to align with ISO 15883-1:2024 and ISO 15883-4:2018;
— revision of normative references and bibliographic references.
A list of all parts in the ISO 15883 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO 15883-7:2025(en)
Introduction
This document is the seventh part of the ISO 15883 series of standards specifying the performance of
washer-disinfectors (WD) and the general requirements for performance applicable to instrument WD. The
requirements given in this document apply to WD used for cleaning and chemical disinfection of non-critical
thermolabile medical devices and health care equipment without further treatment in health care settings.
Such reusable equipment is cleaned and disinfected, but processing in a WD for surgical instruments
(see ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes (see ISO 15883-4), or
for thermal disinfection of non-critical medical devices and health care equipment (see ISO 15883-6), is
inappropriate and/or impractical. Examples of the equipment to which this document applies are beds and
bedside furniture, trolleys and transport carts, operating tables, footwear, wheelchairs, or aids for people
with disabilities.
Requirements for WD for other applications are specified in other parts of ISO 15883.
Safety requirements for WD are given in IEC 61010-2-040.
The quality of water to be used in a WD is covered in ISO/TS 5111.
NOTE Local or national regulations can apply in respect of the potential adverse effects on the quality of water
intended for human consumption or environmental impacts caused by the WD and its intended use.
vi
International Standard ISO 15883-7:2025(en)
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical
devices and health care equipment
1 Scope
This document specifies the requirements for washer-disinfectors (WD) intended to be used for the cleaning
and chemical disinfection, in a single operating cycle, of reusable items such as:
a) bed frames;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs;
i) aids for persons with disabilities.
This document also specifies the performance requirements for the cleaning and disinfection of the WD and
its components and accessories.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO 15883-4, and ISO 15883-6 do not fall
within the scope of this document.
In addition, this document specifies the methods for type testing, works testing, validation (installation,
operation, and performance qualification on first installation), routine control, and monitoring, as well as
requalifications to be carried out periodically and after essential repairs.
NOTE 1 WD covered by this document can also be used for cleaning and chemical disinfection of other thermolabile
and reusable devices as recommended in the instructions for use (IFU) for those devices.
NOTE 2 The performance requirements specified in this document cannot ensure the inactivation or removal of
the causative agent(s) (prion proteins) of transmissible spongiform encephalopathies.
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 11139:2018, Sterilization of health care products — Vocabulary of terms used in sterilization and related
equipment and process standards
ISO 15883-7:2025(en)
ISO 11139:2018/Amd1:2024, Sterilization of health care products — Vocabulary of terms used in sterilization
and related equipment and process standards — Amendment 1: Amended and additional terms and definitions
ISO 15883-1:2024, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical
disinfection for thermolabile endoscopes
ISO 15883-5:2021, Washer-disinfectors — Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy
1)
ISO 15883-6 , Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal
disinfection for non-invasive, non-critical medical devices and health care equipment
IEC 61010-2-040:2020, 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 10088-1, Stainless steels — Part 1: List of stainless steels
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes
EN 12353:2021, 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 13727:2012+A2:2015, 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 11139:2018,
ISO 11139:2018/Amd1:2024, ISO 15883-1, ISO 15883-4, ISO 15883-5, ISO 15883-6 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
non-critical device
item processed in a washer-disinfector, whose surface(s) are intended to contact
intact skin of a body but do not penetrate it, or device not intended for direct patient contact
EXAMPLE Blood pressure cuffs, wheelchairs, trays, bowls, dishes, glassware, receivers, containers for transit.
Note 1 to entry: National regulations can use alternative wording for the definition of this term when applied to
medical devices.
[SOURCE: ISO 11139:2018/Amd1:2024, 3.357]
1) Under revision with a modified title, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors
employing thermal disinfection for non-critical medical devices and health care equipment. Stage at the time of publication:
ISO/DIS 15883-6:2024.
ISO 15883-7:2025(en)
4 Performance requirements
4.1 General
4.1.1 The requirements of ISO 15883-1 apply, with the exception of:
— ISO 15883-1:2024, 4.3.1 (which refers to thermal disinfection);
— ISO 15883-1:2024, 5.9 [process temperature control limits, however, ISO 15883-1:2024 5.9 d) and f) do apply];
— ISO 15883-1:2024, 5.11 [process verification, however ISO 15883-1:2024 5.11.4 b) does apply].
4.1.2 The WD shall be designed to clean and chemically disinfect non-critical thermolabile medical devices
and health care equipment.
4.1.3 When necessary, the WD shall be provided with means to facilitate the correct alignment of the load
in the washing chamber.
4.1.4 The means to control the volume of the process chemical(s) admitted (see ISO 15883-1:2024, 5.7.4
and 5.7.5) shall be adjustable by means of an access device. The accuracy of the dosing system shall be at
least ±10 % or as specified and tested for conformity (see 6.6).
4.1.5 The automatic controller shall verify that the final concentration of disinfectant(s) is within
specified limits.
NOTE Confirmation of the concentration of disinfectant can include the measurement of the volume of disinfectant
and water admitted together with a certificate of conformity from the disinfectant supplier for the concentration of
the disinfectant, together with data to support the shelf life, expiry date, etc.
4.2 Cleaning
4.2.1 Cleaning shall be tested in accordance with the requirements of ISO 15883-1 using the methods
described in ISO 15883-5:2021, Clause 5 that are relevant to the loads to be processed.
4.2.2 During the washing stage:
a) the washing stage starts when the temperature at the control sensor of the WD is not less than the
minimum specified washing temperature;
b) the washing temperature band shall have the lower limit defined by the washing temperature and an
upper limit not greater than that defined in ISO 15883-1:2024, 4.2.3.
4.2.3 Cleaning efficacy shall be determined in accordance with 6.7.
4.2.4 If the WD is designed to allow the reuse of the cleaning agent on two (2) or more consecutive
operating cycles, then care shall be taken to ensure that the efficacy and safety (e.g. accumulation of
foreign material, device compatibility) of the cleaning solution is not impaired. This shall include testing in
accordance with 6.6.2 and at least the following considerations.
a) Specified methods shall be used to ensure that the cleaning agent has retained the required cleaning
efficacy. These methods shall be based on validation studies relevant to the cleaning agent, to determine
suitable parameter(s) or indicator(s)/marker(s) that can be monitored. Suitable parameters may include
the concentration of the active ingredient and other ingredients that can also affect performance (e.g. pH).
NOTE Minor changes in formulation of the cleaning agent can have a significant effect on its stability, cleaning
efficacy, and other aspects of performance.
ISO 15883-7:2025(en)
b) Recommendations to the user for the maximum period or number of operating cycles for which the
cleaning agent may be used. This shall be based on validated experimental data.
c) Where validated use conditions (maximum period or number of operating cycles) are exceeded, the
automatic controller shall
— operate an audible and visible alarm and prevent the use of the operating cycle until the cleaning
agent is changed, or
— effect an automatic change of the cleaning agent in the WD.
d) If final rinse water including processing chemicals is to be reused (recycled) for a cleaning stage,
absence of negative effects using the defined reuse instructions shall be demonstrated as defined in
ISO 15883-1:2024, 4.2 and 4.4.
4.3 Disinfection
4.3.1 The operating cycle shall include a chemical disinfection stage, which may be combined with the
cleaning and shall be deemed to ha
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