EN ISO 15883-1:2025

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)

This document specifies general performance requirements for washer-disinfectors (WD) and washer-disinfector accessories that are intended to be used for cleaning and disinfection of reusable medical devices. It specifies performance requirements for cleaning and disinfection as well as for the accessories that can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and requalification, periodically and after essential repairs, are also specified.
NOTE 1        The requirements can be applied to WD intended for use with other articles used in the context of medical, dental, pharmaceutical and veterinary practice.
The requirements for WD intended to process specific loads are specified in ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7. For WD intended to process loads of two or more different types, the requirements of the applicable parts of ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 and ISO 15883-7 apply.
This document does not specify requirements intended for machines for use for laundry or general catering purposes.
This document does not include requirements for machines which are intended to sterilize the load, or which are designated as “sterilizers” and addressed in other standards.
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 2        Chemicals in some cleaning agents and disinfectants can react with prion protein in a manner that can inhibit its removal or inactivation.  If the presence of prion protein is considered a possibility, then this can influence the choice of cleaning agent and disinfectant.
NOTE 3        This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of conformity with the requirements of this document can also be employed by users to demonstrate continued conformity of the installed WD throughout its service life. Guidance on a routine test programme is given in Annex A.

Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO 15883-1:2024)

Dieses Dokument legt allgemeine Leistungsanforderungen an Reinigungs-Desinfektionsgeräte (RDG) und Zubehör der Reinigungs-Desinfektionsgeräte fest, die für die Reinigung und Desinfektion wiederverwendbarer Medizinprodukte vorgesehen sind. Es legt die Leistungsanforderungen für die Reinigung und Desinfektion sowie für das Zubehör fest, die zum Erreichen der erforderlichen Leistung notwendig sein können. Ebenso werden die Verfahren und Messgeräte festgelegt, die für die Validierung, die Routineprüfung sowie Routineüberwachung und die Requalifizierung, die in periodischen Abständen und nach wesentlichen Reparaturen erfolgt, benötigt werden.
ANMERKUNG 1   Die Anforderungen können auf RDG, die für die Verwendung mit sonstigen im medizinischen, zahnmedizinischen, pharmazeutischen und veterinärmedizinischen Bereich verwendeten Gegenständen vorgesehen sind, angewendet werden.
Die Anforderungen an die zur Behandlung spezifischer Beladungen bestimmten RDG sind in ISO 15883 2, ISO 15883 3, ISO 15883 4, ISO 15883 6 und ISO 15883 7 festgelegt. Für RDG, die für die Behandlung von zwei oder mehreren Arten von Beladungsgütern bestimmt sind, gelten die Anforderungen der anwendbaren Teile von ISO 15883 2, ISO 15883 3, ISO 15883 4, ISO 15883 6 und ISO 15883 7.
Dieses Dokument legt keine Anforderungen für Geräte fest, die für die Anwendung in Wäschereien oder im Bereich der Lebensmittelzubereitung bestimmt sind.
Dieses Dokument enthält keine Anforderungen an Geräte, die für die Sterilisation der Beladung bestimmt sind oder als „Sterilisatoren“ bezeichnet werden; diese werden in anderen Normen behandelt.
Die in diesem Dokument festgelegten Leistungsanforderungen stellen keine Inaktivierung oder die Beseitigung des (der) verursachenden Agens (Agenzien) (Prionenproteine) von transmissiblen spongiformen Enzephalopathien sicher.
ANMERKUNG 2   Die in einigen Reinigungs- und Desinfektionsmitteln enthaltenen Chemikalien können mit Prionenprotein in einer Weise reagieren, die dessen Beseitigung oder Inaktivierung verhindern kann. Wenn in Betracht kommt, dass Prionenproteine vorhanden sein können, kann dies die Wahl des Reinigungs- und Desinfektionsmittels beeinflussen.
ANMERKUNG 3   Dieses Dokument kann von zukünftigen Abnehmern und Herstellern als Grundlage der Vereinbarung über die Spezifikation eines RDG verwendet werden. Die Prüfverfahren zum Nachweis der Übereinstimmung mit den Anforderungen aus diesem Dokument können auch durch Anwender verwendet werden, um die ständige Übereinstimmung des installierten RDG mit der Norm während seiner Nutzungsdauer nachzuweisen. Eine Anleitung zu einem Routineprüfprogramm wird in Anhang A gegeben.

Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO 15883-1:2024)

Le présent document spécifie les exigences de performances générales relatives aux laveurs désinfecteurs (LD) et à leurs accessoires qui sont destinés à être utilisés pour le nettoyage et la désinfection de dispositifs médicaux réutilisables. Il spécifie les exigences de performances pour le nettoyage et la désinfection ainsi que pour les accessoires qui peuvent être nécessaires pour atteindre les performances requises. Les méthodes et les instruments nécessaires pour la validation, le contrôle de routine, la surveillance et la requalification, réalisés périodiquement et après des réparations essentielles, sont aussi spécifiés.
NOTE 1        Les exigences peuvent être appliquées aux LD destinés à une utilisation en association avec d’autres articles utilisés dans le contexte d’activités médicales, dentaires, pharmaceutiques et vétérinaires.
Les exigences pour les LD destinés à traiter des charges spécifiques sont spécifiées dans l’ISO 15883-2, l’ISO 15883-3, l’ISO 15883-4, l’ISO 15883-6 et l’ISO 15883-7. Pour les LD destinés à traiter des charges de deux types différents ou plus, les exigences aux parties applicables de l’ISO 15883-2, l’ISO 15883-3, l’ISO 15883-4, l’ISO 15883-6 et l’ISO 15883-7 s’appliquent.
Le présent document ne spécifie aucune exigence concernant les laveurs désinfecteurs utilisés en blanchisserie ou en restauration générale.
Le présent document n’inclut aucune exigence pour les laveurs désinfecteurs destinés à stériliser la charge ou considérés comme des «stérilisateurs» et traités dans d’autres normes.
Les exigences de performance spécifiées dans le présent document n’assurent pas l’inactivation ou l’élimination de l’agent ou des agents infectieux (protéine du prion) des encéphalopathies spongiformes transmissibles.
NOTE 2        Les produits chimiques contenus dans certains agents nettoyants et désinfectants peuvent réagir avec la protéine du prion d’une manière qui peut inhiber son élimination ou son inactivation. Si la présence de la protéine du prion est considérée comme une possibilité, cela peut influer sur le choix de l’agent nettoyant et du désinfectant.
NOTE 3        Le présent document peut être utilisé par des acheteurs potentiels et des fabricants sur la base de l’accord sur la spécification d’un LD. Les méthodes d’essai pour la démonstration de conformité aux exigences du présent document peuvent également être utilisées par les utilisateurs afin de démontrer une conformité continue du LD installé au cours de sa durée de vie. Des recommandations relatives à un programme d’essai de routine sont données dans l’Annexe A.

Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in preskusi (ISO 15883-1:2024)

Ta dokument določa osnovne zahteve glede učinkovitosti čistilno-dezinfekcijskih naprav (WD) in njihovih pripomočkov, ki so namenjeni za čiščenje in razkuževanje medicinskih pripomočkov za ponovno uporabo. Določa zahteve za učinkovitost čiščenja in razkuževanja ter za pripomočke, ki jih je mogoče zahtevati za dosego želene učinkovitosti. Podani so tudi metode in instrumenti, potrebni za validacijo, rutinsko kontrolo in nadzor ter vnovično potrditev ustreznosti, periodično in po nujnih popravilih. OPOMBA 1:        Zahteve je mogoče uporabiti za čistilno-dezifekcijske naprave za uporabo z drugimi izdelki, ki se uporabljajo v zdravstveni, zobozdravstveni, farmacevtski in veterinarski praksi. Zahteve za čistilno-dezinfekcijske naprave za obdelavo določenih polnjenj so podane v standardih ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 in ISO 15883-7. Za čistilno-dezinfekcijske naprave za obdelavo polnjenj dveh ali več različnih tipov veljajo zahteve ustreznih delov standardov ISO 15883-2, ISO 15883-3, ISO 15883-4, ISO 15883-6 in ISO 15883-7. Ta dokument ne določa zahtev za stroje, ki se uporabljajo za pranje perila ali posebne namene v gostinstvu. Ta dokument ne vključuje zahtev za stroje, ki se uporabljajo za sterilizacijo polnjenja ali so načrtovani kot sterilizatorji in obravnavani v drugih standardih. Določene zahteve glede učinkovitosti v tem dokumentu ne zagotavljajo inaktivacije ali odstranitve vzročnih povzročiteljev (prionskih beljakovin) prenosljivih spongiformnih encefalopatij. OPOMBA 2:        Kemikalije v nekaterih čistilnih sredstvih in razkužilih lahko reagirajo s prionsko beljakovino na način, ki lahko zavira njeno odstranitev ali inaktivacijo.  Morebitna prisotnost prionske beljakovine lahko vpliva na izbiro čistilnega sredstva in razkužila. OPOMBA 3:        Ta dokument lahko uporabljajo potencialni kupci in proizvajalci kot osnovo za dogovor o specifikaciji čistilno-dezifekcijske naprave. Preskusne metode za prikaz skladnosti z zahtevami tega dokumenta lahko uporabijo uporabniki za prikaz trajne skladnosti nameščene čistilno-dezifekcijske naprave med življenjsko dobo delovanja. V dodatku A so podane smernice za rutinski program preskušanja.

General Information

• Status: Published
• Publication Date: 11-Mar-2025
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 8 - Performance requirements and testing for washer-disinfectors
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Mar-2025
• Completion Date: 12-Mar-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: SIST EN ISO 15883-1:2025 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)

Relations

• Replaces: EN ISO 15883-1:2009/A1:2014 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1:2014)
• Effective Date: 28-Jan-2023
• Replaces: EN ISO 15883-1:2009 - Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
• Effective Date: 28-Jan-2023

Overview

EN ISO 15883-1:2025 (ISO 15883-1:2024) - Washer‑disinfectors - Part 1 - establishes the general requirements, terms, definitions and test methods for washer‑disinfectors (WD) and WD accessories intended for the cleaning and disinfection of reusable medical devices. The standard defines performance requirements for both cleaning and disinfection, and specifies the methods and instrumentation needed for validation, routine control/monitoring and requalification (periodic and after essential repairs). It is the foundational part of the ISO 15883 series and is published as EN ISO 15883-1:2025.

Key topics and technical requirements

• Scope and applicability: Applies to WD used for medical, dental, pharmaceutical and veterinary reusable devices; excludes laundry or general catering machines and machines designated as sterilizers.
• Performance requirements: General performance criteria for cleaning and disinfection and for accessories required to achieve those outcomes.
• Validation and monitoring: Specifies methods and instrumentation needed for initial validation, routine performance control, ongoing monitoring and requalification after repairs.
• Terms and definitions: Standardizes vocabulary for washer‑disinfectors to improve consistency in specification and testing.
• Test methods: Provides standardized tests to demonstrate conformity with cleaning/disinfection performance requirements (guidance for routine test programmes is in Annex A).
• Limitations and safety notes: States that prescribed performance does not ensure removal/inactivation of prion proteins (TSE agents) and notes chemical interactions can affect prion removal - this influences choice of cleaning agents and disinfectants.
• Regulatory alignment: Includes informative Annex ZA demonstrating relationship to EU Regulation (EU) 2017/745 on medical devices and references related normative standards (e.g., ISO 14971 on risk management, IEC 61010‑2‑040 for sterilizers/WD equipment).

Practical applications - who uses this standard

• Manufacturers - design and verify WD performance, prepare technical documentation and validation protocols.
• Procurement teams / purchasers - use the standard as a basis for specifications and acceptance criteria when acquiring washer‑disinfectors.
• Hospital sterilization/central sterile services departments (CSSD) - validate, monitor and requalify installed WD to ensure consistent cleaning/disinfection performance.
• Regulatory and compliance professionals - demonstrate conformity with safety and performance expectations and support conformity assessment.
• Service engineers and validation specialists - perform routine testing, repairs and requalification in line with standardized methods.

Related standards

• ISO 15883‑2, ‑3, ‑4, ‑6, ‑7 - specific requirements for different WD load types (thermal/chemical disinfection, endoscopes, waste containers, non‑critical devices).
• ISO 15883‑5 - test methods for demonstrating cleaning efficacy.
• Normative references include ISO 14971 (risk management), ISO 14644‑3 (cleanroom test methods) and IEC 61010‑2‑040 (safety for sterilizers/WD).

Keywords: washer‑disinfectors, WD validation, cleaning and disinfection, reusable medical devices, ISO 15883-1, requalification, routine control, medical device processing.

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2025
Nadomešča:
SIST EN ISO 15883-1:2009
SIST EN ISO 15883-1:2009/A1:2014
Čistilno-dezinfekcijske naprave - 1. del: Osnovne zahteve, termini, definicije in
preskusi (ISO 15883-1:2024)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO
15883-1:2024)
Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und
Prüfverfahren (ISO 15883-1:2024)
Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais
(ISO 15883-1:2024)
Ta slovenski standard je istoveten z: EN ISO 15883-1:2025
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-1:2009, EN ISO 15883-
1:2009/A1:2014
English Version
Washer-disinfectors - Part 1: General requirements, terms
and definitions and tests (ISO 15883-1:2024)
Laveurs désinfecteurs - Partie 1: Exigences générales, Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine
termes et définitions et essais (ISO 15883-1:2024) Anforderungen, Begriffe und Prüfverfahren (ISO
15883-1:2024)
This European Standard was approved by CEN on 12 July 2024.

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 15883-1:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 4

European foreword
This document (EN ISO 15883-1:2025) 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 September 2025, and conflicting national standards
shall be withdrawn at the latest by September 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 15883-1:2009, EN ISO 15883-1:2009/A1:2014.
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 15883-1:2024 has been approved by CEN as EN ISO 15883-1:2025 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard 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
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/745
5 (a) 5.1.2.5, 5.4.2, 5.4.3, 5.19, 5.22, The selected clauses 5.1.2.5,
5.27.1, 5.28 5.4.2, 5.4.3, 5.19, 5.22, 5.27.1
and 5.28
partly cover the requirement.
Covered in respect of reducing

the risks related to use error by
reducing the risks related to the
ergonomic features of the
washer-disinfectors (WD).
Aspects related to the
environment in which the WD is
intended to be used are not
covered. Aspects related to
manufacturing are also not
covered.
5 (b) 5.20, 8.3 The selected clauses 5.20 and
8.3 partly cover the
requirement. Covered in respect
of reducing the risks related to
use error by considering the
training of the user and
technical knowledge.
Aspects related to the
experience, education and use
environment, where applicable,
and the medical and physical
conditions of intended users are
not covered.
7 9.2 The selected clause 9.2 partly
covers the requirement.
Covered with respect to
packaging to protect the device
during transport and storage.
Aspects related to the design
and manufacture are not
covered.
10.2 5.1.2.6, 5.1.2.7, 5.4.1.2, 5.4.5.1, The selected clauses 5.1.2.6,
5.4.5.3, 5.5.1, 5.24.4, 5.25 5.1.2.7, 5.4.1.2, 5.4.5.1, 5.4.5.3,
5.5.1, 5.24.4 and 5.25 partly
cover the requirement. Covered
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/745
in respect with the minimizing
the risk posed by contaminants
and residues to patients and the
persons involved in use of the
WD.
Aspects related to the
packaging are not covered.
10.3, first part only 5.1.1.1, 5.1.1.2 The selected clauses 5.1.1.1 and
5.1.1.2 partly cover the
requirement. Covered in respect
with the safety use of WD with
materials and substances with
which it enters into contact
during intended use.
WD devices are not intended to
administer medicinal products,
that’s why the second part of
this requirement is not covered.
10.4.1, first sentence only 5.1.2.6, 5.1.2.7, 5.4.1.2, 5.4.5.3 The selected clauses 5.1.2.6,
5.1.2.7, 5.4.1.2 and 5.4.5.3 partly
cover the requirement. Covered
in respect with the risks posed
by substances and processing
residues, that may be released
from the WD.
Aspects related to the particles,
including wear debris, and
degradation products are not
covered.
WD devices are not intended to
administer medicinal products,
that’s why the second part of
this requirement is not covered.
11.1, first sentence only 4.2, 4.3, 5.3, 5.4, 5.5.1, 5.6.1, 5.9, The selected clauses 4.2, 4.3,
5.11, 5.12.6, 5.24.4, 5.24.5, 5.26 5.3, 5.4, 5.5.1, 5.6.1, 5.9, 5.11,
5.12.6, 5.24.4, 5.24.5 and 5.26
partly cover the requirement.
Covered in respect of reducing
the risks of infection to patients,
users and, where applicable,
other persons by effective
cleaning and disinfection of the
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/745
load.
Aspects related to the WD
manufacturing processes are
not covered.
11.1 (d) 5.1.3, 5.3.1, 5.3.5, 5.5.1, 5.6.2 The selected clauses 5.1.3, 5.3.1,
5.3.5, 5.5.1 and 5.6.2 partly
cover the requirement. Covered
with respect of design of WD to
prevent microbial
contamination of the device or
its content.
Aspects related to the WD
manufacturing processes are
not covered.
11.2 5.1.1, 5.1.3.2, 5.1.3.4, 5.6.3, The selected clause 5.1.1 partly
5.25.1, 5.26, 5.28.3 covers the requirement.
Covered with respect of design
of WD to facilitate its safe
cleaning and disinfection.
The other clauses 5.1.3.2,
5.1.3.4, 5.6.3, 5.25.1, 5.26 and
5.28.3 also cover this
requirement.
Aspects related to the (re-)
sterilisation of the WD are not
covered.
14.1, first sentence only 5.1.3, 5.28 The selected clauses 5.1.3 and
5.28 cover the requirement in
respect of load carrier(s) and
trolleys used with WD.
14.2 (a) 5.1.2.5, 5.1.3, 5.4.2, 5.4.3, 5.10, The selected clauses 5.1.2.5,
5.12.3, 5.22.3, 5.22.4, 5.27.1 5.1.3, 5.4.2, 5.4.3, 5.10, 5.12.3,
5.22.3, 5.22.4 and 5.27.1 cover

the requirement in respect of
reducing the risks of injury, in
connection with WD physical
features, dimensional and
ergonomic features.
14.2 (b) 5.2, 5.29 The selected clause 5.29 covers
the requirement in respect of
reducing the risks connected
with reasonably foreseeable
environmental conditions.
The clause 5.2 covers other
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/745
important aspects related to
external influences.
18.8 5.4.1.6, 5.4.5.4, 5.7.2, 5.18.2.10, The selected clauses 5.4.1.6,
5.19.8, 5.20.1 c), 5.20.2 a), 5.21 5.4.5.4, 5.7.2, 5.18.2.10, 5.19.8,
(a), 5.21 d), 5.21 j), 5.22.3 5.20.1 c), 5.20.2 a), 5.21 (a),
5.21 d), 5.21 j) and 5.22.3 cover
the requirement in respect of
preventing unauthorized access
on the device.
21.3 5.10, 5.12.2, 5.12.3 The selected clauses 5.10,
5.12.2 and 5.12.3 cover the
requirement in respect of the
design of indicators and
symbols.
23.4 q) 7, 8.2 a), 8.2 b), 8.2 g), 8.2 h) The selected clauses 7, 8.2 a),
8.2 b), 8.2 g) and 8.2 h) cover
the requirement in respect of
documentation provided for
installation.
23.4 k) 6.1.3, 7, 8.2, 8.3 The selected clauses 6.1.3, 7, 8.2
and 8.3 cover the requirement
in respect of documentation
provided for installation,
operation and maintenance.
Covered only in respect of
validation before use.
Table ZA.2 — Normative references from Clause 2 of this document and their corresponding
European publications
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding
Clause 2 Standard
European Standard
Edition
Edition
Graphical symbols for use on
For applicable standard
ISO 7000 ISO 7000:2019 equipment — Registered
edition see Column 2
symbols
Measurement management
systems — Requirements for
ISO 10012 ISO 10012:2003 EN ISO 10012:2003
measurement processes and
measuring equipment
Cleanrooms and associated
ISO 14644-3:201
ISO 14644-3 controlled environments — Part EN ISO 14644-3:2019
3: Test methods
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding
Clause 2 Standard
European Standard
Edition
Edition
Medical devices — Application EN ISO 14971:2019
of risk management to medical
ISO 14971 ISO 14971:2019
EN ISO
devices
14971:2019/A11:2021
Washer-disinfectors — Part 2:
Requirements and tests for
washer-disinfectors employing
ISO 15883-
EN ISO 15883-2:2025
thermal disinfection for surgical
2:2024
ISO 15883-2
instruments, anaesthetic
equipment, bowls, dishes,
receivers, utensils, glassware,
etc.
Washer-disinfectors — Part 3:
ISO 15883-
Requirements and tests for
EN ISO 15883-3:2025
3:2024
ISO 15883-3
washer-disinfectors employing
thermal disinfection for human

waste containers
Washer-disinfectors — Part 4:
ISO 15883-
Requirements and tests for
EN ISO 15883-4:2018
4:2018
ISO 15883-4 washer-disinfectors employing

chemical disinfection for
thermolabile endoscopes
Washer-disinfectors — Part 5:
ISO
EN ISO 15883-5:2021
Performance requirements and
15883-5:2021
ISO 15883-5:2021
test method criteria for
demonstrating cleaning efficacy
Washer-disinfectors — Part 6:
Requirements and tests for
ISO 15883-
washer-disinfectors employing
EN ISO 15883-6:2015
6:2011
ISO 15883-6 thermal disinfection for non-

invasive, non-critical medical

devices and healthcare
equipment
Washer-disinfectors — Part 7:
Requirements and tests for
washer-disinfectors employing
ISO 15883-
ISO 15883-7 chemical disinfection for non- EN ISO 15883-7:2016
7:2016
invasive, non-critical
thermolabile medical devices
and healthcare equipment
IEC 60417-DB:2 Graphical symbols for use on For applicable standard
IEC 60417-DB
002 equipment edition see Column 2
IEC 60584-1:201 Thermocouples — Part 1: EMF
IEC 60584-1:2013 EN 60584-1:2013
3 specifications and tolerances
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding
Clause 2 Standard
European Standard
Edition
Edition
Industrial platinum resistance
IEC 60751:2008 IEC 60751:2008 thermometer and platinum EN 60751:2008
temperature sensors
Safety requirements for
electrical equipment for
measurement, control and
IEC 61010-2-040:2 IEC 61010- laboratory use – Part 2-040: EN IEC 61010-
020 2-040:2020 Particular requirements for 2-040:2021
sterilizers and washer-
disinfectors used to treat
medical materials
Electrical equipment for
measurement, control and
IEC 61326-1:202
IEC 61326-1:2020 laboratory use. EMC EN IEC 61326-1:2021
requirements – Part 1: General
requirements
Basic principles for graphical
IEC 80416-1:200 symbols for use on equipment
IEC 80416-1 EN 80416-1:2009
8 — Part 1: Creation of graphical
symbols for registration
European Pharmacopoeia,
European Assays – 2.5.30 Oxidising
None None
Pharmacopoeia substances; Biological tests -
2.6.14 Bacterial endotoxins
United States Pharmacopeia,
Chemical tests <541>
United States Titrimetry, Oxidation-Reduction
None None
Pharmacopeia (Redox) titrations; Biological
tests <85> Bacterial endotoxins
test
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 Indents 5, 7, 9, 10, 11 and 5.7.4, 5.12.1, 5.12.5, 5.12.7, The selected clauses 5.7.4,
last paragraph 5.12.10, 5.19.14, 5.22 5.12.1, 5.12.5, 5.12.7, 5.12.10,
5.19.14 and 5.22 cover the
requirement in respect
withstanding the intended
operating stress and prevent
hazardous situations by
failures of the equipment
and/or the control system.
1.3.2 paragraph 4 5.1, 8.1 e), 8.3 g) The selected clauses 5.1, 8.1 e)
and 8.3 g) cover the
requirement in respect to
minimize the risk of
breakdown by leaking of
hazardous substances during
normal 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 15883-1
Second edition
Washer-disinfectors —
2024-10
Part 1:
General requirements, terms and
definitions and tests
Laveurs désinfecteurs —
Partie 1: Exigences générales, termes et définitions et essais
Reference number
ISO 15883-1:2024(en) © ISO 2024

© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .vi
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Performance requirements . .10
4.1 General .10
4.2 Cleaning .14
4.2.1 General .14
4.2.2 Pre-wash flushing stage .14
4.2.3 Washing stage .14
4.2.4 Rinsing stage. 15
4.3 Disinfection . 15
4.3.1 Thermal disinfection . 15
4.3.2 Chemical disinfection . 15
4.4 Final rinsing .16
4.5 Drying .17
4.6 Process chemicals .17
4.7 Self-disinfection .17
5 Mechanical and process requirements .18
5.1 Materials, design and manufacture/construction .18
5.1.1 Materials .18
5.1.2 Design and manufacture/construction .19
5.1.3 Load carrier(s) . 20
5.2 Safety. 20
5.3 Tanks .21
5.4 Loading and unloading doors and their controls . 22
5.4.1 General . 22
5.4.2 Control of manually operated doors . 23
5.4.3 Control of doors of a double-ended WD . 23
5.4.4 Internal doors and access ports. 23
5.4.5 Continuous process machine without doors . 23
5.5 Pipework and fittings .24
5.6 Spray systems .24
5.7 Dosing systems . .24
5.8 Load temperature protection . 25
5.9 Process temperature control limits . 25
5.10 Switches, gauges and indicating devices . 26
5.11 Process verification .27
5.12 Instrumentation and controls. 28
5.13 Temperature indicating systems . . . 29
5.14 Pressure indicating systems . 30
5.15 Volume/flow indicating devices . 30
5.16 Timing equipment .31
5.17 Operating cycle indicating equipment .31
5.18 Recording systems (if fitted) .31
5.18.1 Cycle control recorders.31
5.18.2 Process verification system .31
5.19 Control systems . 33
5.20 Override of automatic control . 34
5.21 Microprocessor control systems . 34
5.22 Fault indication systems . 35
5.23 Water supply . 35

iii
5.24 Venting and drainage systems. 36
5.25 Drainage . 36
5.26 Air filters installed within the WD .37
5.27 Load handling and supports for use within the WD .37
5.28 Trolleys .37
5.29 Environment . 38
6 Testing for conformity .38
6.1 General . 38
6.1.1 Inter-relationship of tests. 38
6.1.2 Conformity of WD, as supplied, with ISO 15883-1 . 38
6.1.3 Conformity of WD, as installed, with ISO 15883-1 . 38
6.1.4 Confirmation of validation . 40
6.1.5 Requalification . 40
6.1.6 Routine and periodic tests . 40
6.2 Instrumentation for testing .41
6.2.1 Temperature sensors .41
6.2.2 Temperature recording instruments .41
6.2.3 Calibration . . .41
6.3 Tests on doors, interlocks and fault indications .42
6.3.1 Operating cycle start interlock .42
6.3.2 Door locking during operating cycle .42
6.3.3 Door interlocks on double-ended WD .42
6.3.4 Cycle complete door interlocks.43
6.3.5 Fault indication on sensor failure .43
6.3.6 Fault indication on service failure .43
6.3.7 Failed cycle interlock . 44
6.3.8 Blocked drain protection . 44
6.4 Tests on water quality and water volume . 44
6.4.1 General . 44
6.4.2 Quality of final rinse water .45
6.4.3 Volume of water used per stage .45
6.4.4 Quality of water used during testing . 46
6.5 Tests on pipework . 46
6.5.1 Estimation of dead volume pipework . 46
6.5.2 Leakage .47
6.5.3 Free draining [chamber, load carrier(s), tanks].47
6.5.4 Pipework flow to discharge point .47
6.5.5 Venting . .47
6.5.6 Load contamination from ductwork of the WD . 48
6.6 Tests on instrumentation fitted to the WD . 48
6.6.1 Verification of calibration . . 48
6.6.2 Legibility . 49
6.7 Tests on load carrier(s) and trolleys. 49
6.7.1 Load carrier(s) used within the chamber . 49
6.7.2 Trolleys . . 49
6.8 Thermometric tests . 50
6.8.1 General . 50
6.8.2 Load and load carrier(s) temperature test during operating cycle . 50
6.8.3 Chamber wall temperature test.51
6.8.4 Temperature tests on tanks .51
6.8.5 Load temperature protection .52
6.9 Chemical dosing tests .52
6.9.1 Dispensed volume .52
6.9.2 Indication of insufficient process chemical for a cycle . 53
6.10 Tests of cleaning efficacy . 53
6.10.1
...