EN ISO 15883-6:2026

SLOVENSKI STANDARD
01-maj-2026
Nadomešča:
SIST EN ISO 15883-6:2015
Čistilno-dezinfekcijske naprave - 6. del: Zahteve in preskusi čistilno-
dezinfekcijskih naprav s toplotno dezinfekcijo za nenujne medicinske pripomočke
in zdravstveno opremo (ISO 15883-6:2026)
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-critical medical devices and health care equipment (ISO
15883-6:2026)
Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht kritische
Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-6:2026)
Laveurs désinfecteurs - Partie 6: Exigences et essais pour les laveurs désinfecteurs
utilisant une désinfection thermique pour les dispositifs médicaux non invasifs, non
critiques et pour l'équipement de soins de santé (ISO 15883-6:2026)
Ta slovenski standard je istoveten z: EN ISO 15883-6:2026
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-6
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2026
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-6:2015
English Version
Washer-disinfectors - Part 6: Requirements and tests for
washer-disinfectors employing thermal disinfection for
non-critical medical devices and health care equipment
(ISO 15883-6:2026)
Laveurs-désinfecteurs - Partie 6: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 6:
pour les laveurs-désinfecteurs utilisant la désinfection Anforderungen und Prüfverfahren für Reinigungs-
thermique pour les dispositifs médicaux non critiques Desinfektionsgeräte mit thermischer Desinfektion für
et les équipements de soins de santé (ISO 15883- nicht kritische Medizinprodukte und Zubehör im
6:2026) Gesundheitswesen (ISO 15883-6:2026)
This European Standard was approved by CEN on 22 January 2026.

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
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-6:2026 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 15883-6:2026) 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 2026, and conflicting national standards
shall be withdrawn at the latest by September 2026.
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 15883-6:2015.
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 15883-6:2026 has been approved by CEN as EN ISO 15883-6:2026 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) of Remarks / Notes
Performance Requirements of this EN
Regulation (EU) 2017/745
5 (a) 4.1.3, 4.1.4 Clauses 4.1.3, 4.14, 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.
14.2 (a) 4.1.5, 5.1, 5.2 All selected clauses only partly
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) Error! Reference source not Covered in respect of
found.a), Error! Reference documentation provided for
source not found. a) – Error! installation and safe operation
Reference source not found. b) of the WD.
Table ZA.2 — Normative references from clause 2 of this document and their corresponding
European publications
Column 1 Column 2 Column 3 Title Column 4
Corresponding
Reference in International
European Standard
Clause 2 Standard Edition
Edition
ISO 15883- ISO 15883-1:2024 Washer-disinfectors — Part 1: EN ISO 15883-1:2025
1:2024 General requirements, terms and
definitions and tests
ISO 15883-5 ISO 15883-5:2021 Washer-disinfectors — Part 5: EN ISO 15883-5:2021
Performance requirements and
test method criteria for
demonstrating cleaning efficacy
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.
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) of Remarks / Notes
Requirements of Directive 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 4.3.3, 5.1.4, 5.1.5 The selected clauses are covered
to pre-set the disinfection
temperature and time/A0 value
to adapt to different conditions
and clause.
1.6.4 5.1.4, 5.1.5 The selected clauses are covered
with respect to authorized
access for adjustment of
parameters
International
Standard
ISO 15883-6
Second edition
Washer-disinfectors —
2026-01
Part 6:
Requirements and tests for washer-
disinfectors employing thermal
disinfection for non-critical medical
devices and health care equipment
Laveurs-désinfecteurs —
Partie 6: Exigences et essais pour les laveurs-désinfecteurs
utilisant la désinfection thermique pour les dispositifs médicaux
non critiques et les équipements de soins de santé
Reference number
ISO 15883-6:2026(en) © ISO 2026

ISO 15883-6:2026(en)
© ISO 2026
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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Email: copyright@iso.org
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Published in Switzerland
ii
ISO 15883-6:2026(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 .3
4.3 Disinfecting .4
4.4 Water quality .4
5 Mechanical and control requirements . 4
5.1 Control systems .4
5.2 Process verification .5
6 Testing for conformity . 5
6.1 General .5
6.2 Tests for soil removal from chamber walls, load carriers and load .5
6.3 Thermometric tests .5
7 Information to be supplied . 5
8 Information to be requested from the purchaser by the supplier of the WD . 6
Annex A (informative) Summary of test programmes . 7
Bibliography . 8

iii
ISO 15883-6:2026(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 dif
...