EN ISO 15883-2:2025

SLOVENSKI STANDARD
01-maj-2025
Nadomešča:
SIST EN ISO 15883-2:2009
Čistilno-dezinfekcijske naprave - 2. del: Zahteve in preskusi za čistilno-
dezinfekcijske naprave s toplotno dezinfekcijo za kritične in polkritične
medicinske pripomočke (ISO 15883-2:2024)
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024)
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für kritische und
semikritische Medizinprodukte (ISO 15883-2:2024)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique des dispositifs médicaux critiques et semi-critiques
(ISO 15883-2:2024)
Ta slovenski standard je istoveten z: EN ISO 15883-2:2025
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-2
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-2:2009
English Version
Washer-disinfectors - Part 2: Requirements and tests for
washer-disinfectors employing thermal disinfection for
critical and semi-critical medical devices (ISO 15883-
2:2024)
Laveurs désinfecteurs - Partie 2: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 2:
pour laveurs désinfecteurs destinés à la désinfection Anforderungen und Prüfverfahren von Reinigungs-
thermique des dispositifs médicaux critiques et semi- Desinfektionsgeräten mit thermischer Desinfektion für
critiques (ISO 15883-2:2024) kritische und semikritische Medizinprodukte (ISO
15883-2:2024)
This European Standard was approved by CEN on 11 November 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 15883-2:2025 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 15883-2:2025) 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 15883-2:2009.
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 15883-2:2024 has been approved by CEN as EN ISO 15883-2:2025 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
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/745
5 4.1.4, 4.1.5 Clauses 4.1.4 and 4.1.5 only
partly covered in respect of
reducing the risks related to
use error by reducing the risks
related to the ergonomic
features of the washer-
disinfectors (WDs).
Aspects related to the
environment in which the WD
is intended to be used are not
covered.
Aspects related to
manufacturing are not
covered.
Aspects related to the letter b)
are not covered as well.
10.2 4.1.4, 4.1.5, 5.1.2, 5.2, 5.3 All clauses only partly covered
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
manufacture and packaging
are not covered.
Aspects related to the
transport and storage are not
covered as well.
10.3 4.5 Clause 4.5 only partly covers
the requirement. Covered in
respect with the safety use of
WD with the water 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.
Aspects related to the
manufacture are not covered.
14.1 4.1.4 Clause 4.1.4 only partly covers
the requirement. Covered in
respect to the first sentence
only (combination and
connection to the WD)
14.2 (a) 4.1.5, 4.1.7, 5.1.2, 4.1.6, 5.2 and All selected clauses only partly
5.3 cover the requirement.
Covered in respect of reducing
the risks of injury, in
connection with WD physical
and ergonomic features.
Aspects related to the WD
manufacturing processes are
not covered.
23.4 (k) 7 a) – 7 e) The selected clauses 7 a) – 7 e)
only partly cover the
requirement. Cover in respect
of information to be supplied
and needed to verify whether
the device is properly installed
and is ready to perform safely
and as intended by the
manufacturer.
Aspects related to the methods
for eliminating the risks
encountered by persons
involved in installing,
calibrating or servicing devices,
are not covered.
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 Edition
European Standard
Edition
ISO 4017 ISO 4017:2022 Fasteners — Hexagon head screws — EN ISO 4017:2022
Product grades A and B
ISO 5356-2 ISO 5356-2:2012 Anaesthetic and respiratory EN ISO 5356-2:2012
equipment — Conical connectors —
ISO 5356- EN ISO 5356-
Part 2: Screw-threaded weight-bearing
2:2021/Amd 2:2012/A1:2019
connectors
1:2019
ISO 5361 ISO 5361:2023 Anaesthetic and respiratory EN ISO 5361:2023
equipment — Tracheal tubes and
connectors
ISO 5362 ISO 5362:2024 Anaesthetic reservoir bags EN ISO 5362:2024
ISO 5367 ISO 5367:2023 Anaesthetic and respiratory EN ISO 5367:2023
equipment - Breathing sets and
connectors
ISO 15883-1 ISO 15883- Washer-disinfectors — Part 1: General EN ISO 15883-1:2025
1:2024 requirements, definitions and tests
ISO 17664-1:2021 ISO 17664- Processing of health care products — EN ISO 17664-1:2021
1:2021 Information to be provided by the
medical device manufacturer for the
processing of medical devices — Part
1: Critical and semi-critical medical
devices
ISO 15883-5:2021 ISO 15883- Washer-disinfectors — Part 5: EN ISO 15883-5:2021
5:2021 Performance requirements and test
method criteria for demonstrating
cleaning efficacy
EN 10088-2 none Stainless steels - Part 2: Technical EN 10088-2:2024
delivery conditions for sheet/plate and
strip of corrosion resisting steels for
general purposes
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.
International
Standard
ISO 15883-2
Second edition
Washer-disinfectors —
2024-11
Part 2:
Requirements and tests for washer-
disinfectors employing thermal
disinfection for critical and semi-
critical medical devices
Laveurs désinfecteurs —
Partie 2: Exigences et essais pour laveurs désinfecteurs destinés
à la désinfection thermique des dispositifs médicaux critiques et
semi-critiques
Reference number
ISO 15883-2:2024(en) © ISO 2024

ISO 15883-2:2024(en)
© 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
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or ISO’s member body in the country of the requester.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 15883-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Performance requirements . . 3
4.1 General .3
4.2 Cleaning .4
4.3 Disinfecting .4
4.4 Temperature of inner surfaces of processed devices .5
4.5 Water quality .5
5 Mechanical and control requirements . 5
5.1 Lumen and powered devices .5
5.1.1 Irrigation .5
5.1.2 Verification of flow through lumen and powered devices .6
5.2 Control systems .6
5.3 Process verification .6
6 Testing for conformity . 6
6.1 General .6
6.2 Tests for soil removal from chamber walls, load carrier(s) and load .7
6.3 Thermometric tests .7
6.3.1 General .7
6.3.2 Temperature of outer surfaces of devices .7
6.3.3 Temperature of inner surfaces of devices .8
6.4 Pressure and flow measurement .9
7 Information to be provided for the WD . 9
8 Information to be requested from the purchaser by the supplier of the WD . 9
Annex A (informative) Summary of test programmes . 10
Annex B (informative) Guidance on the designation of a medical device to a product family for
cleaning and thermal disinfection processes .11
Bibliography . 14

iii
ISO 15883-2:2024(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 documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products, 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 15883-2:2006), which has been technically
revised.
The main changes are as follows:
— change of title to reflect application to critical and semi-critical medical devices;
— addition of new terms defining critical and semi-critical medical devices, and non-critical devices;
— alignment of other terms and definitions with ISO 11139:2018+Amd 1:2024;
— revision of cross-references to relevant clauses in ISO 15883-1:2024 and ISO 15883-5:2021;
— the upper limit of the washing temperature band reduced to +5 °C;
— addition of a clause on water quality (see 4.5);
— clarification of requirements for lumen and powered devices (see 5.1);
— addition of informative Annex B providing guidance on assigning a medical device to a product family for
cleaning and thermal disinfection processes;
— revision of references in the Bibliography.
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.

iv
ISO 15883-2:2024(en)
Introduction
This document is the second 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 thermal disinfection of critical and
semi-critical medical devices intended for reuse such as:
— surgical instruments, which are divided into instrument product families based on design features,
e.g. instruments without hinges, cavities or lumens, with hinges, with sliding shafts, with lumens,
microsurgical instruments, and complex instruments (e.g. robotic);
— powered instruments;
— anaesthetic and respiratory equipment;
— medical devices comprising glass components;
— any non-critical devices used in conjunction with critical and semi-critical medical devices.
Requirements for WD for other applications, such as for processing non-critical devices and thermolabile
endoscopes, are specified in other parts of the ISO 15883 series of standards.
When processed in the WD, the medical devices can be intended for immediate use or can be intended for
further processing. In both cases, the efficacy of the cleaning and disinfection is of major importance. In
either case, this is for the well-being of the patient. In the latter case, it is also for the safety of the staff
who handles the instruments in the process of inspection, testing and packing as well as ensuring that the
sterilization process is not challenged by residual soil.
The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection
process. Users should be aware that some medical devices can require pre-treatment, e.g. soaking, brushing,
ultrasonic pre-cleaning, lumen irrigation or any combination of these techniques. Reference should be made
to the medical device instructions for reprocessing (see also the ISO 17664 series).
Safety requirements for WD are given in IEC 61010-2-040.
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.

v
International Standard ISO 15883-2:2024(en)
Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical devices
1 Scope
This document specifies requirements for washer-disinfectors (WD) that are intended for use for the cleaning
and thermal disinfection, in a single operating cycle, of reusable critical and semi-critical medical devices,
such as surgical instruments, anaesthetic equipment, and any non-critical devices used in conjunction with
critical and semi-critical medical devices, such as bowls, dishes and receivers, utensils and glassware.
This document is intended to be used in conjunction with the general requirements specified in
ISO 15883-1:2024, except those specified in 4.1.1.
NOTE The specified performance requirements of this document cannot ensure the inactivation or removal of the
causative agent(s) (prion protein) 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 4017, Fasteners — Hexagon head screws — Product grades A and B
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-
bearing connectors
ISO 5361, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
ISO 5362, Anaesthetic and respiratory equipment — Anaesthetic reservoir bags
ISO 5367, Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 15883-1:2024, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-5:2021, Washer-disinfectors — Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion
resisting steels for general purposes
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1:2024 and the following apply.

ISO 15883-2:2024(en)
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
access device
means by which entry to restricted parts of equipment is achieved
Note 1 to entry: This can be by dedicated key, code or tool.
[SOURCE: ISO 11139:2018, 3.4]
3.2
critical medical device
item processed in a washer-disinfector, intended to be introduced directly into, or
have contact with, the vascular system or
...