SIST 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)
...