SIST EN ISO 15883-7:2025

SLOVENSKI STANDARD
01-julij-2025
Nadomešča:
SIST EN ISO 15883-7:2016
Čistilno-dezinfekcijske naprave - 7. del: Zahteve in preskusne metode za čistilno-
dezinfekcijske naprave s kemično dezinfekcijo za nekritične termolabilne
medicinske pripomočke in zdravstveno opremo (ISO 15883-7:2025)
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical devices and health care
equipment (ISO 15883-7:2025)
Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische
thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO 15883-7:2025)
Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs
destinés à la désinfection chimique des dispositifs médicaux thermosensibles non
critiques et des équipements de soins de santé (ISO 15883-7:2025)
Ta slovenski standard je istoveten z: EN ISO 15883-7:2025
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-7
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2025
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-7:2016
English Version
Washer-disinfectors - Part 7: Requirements and tests for
washer-disinfectors employing chemical disinfection for
non-critical thermolabile medical devices and health care
equipment (ISO 15883-7:2025)
Laveurs désinfecteurs - Partie 7: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 7:
pour les laveurs désinfecteurs destinés à la Anforderungen und Prüfverfahren für Reinigungs-
désinfection chimique des dispositifs médicaux Desinfektionsgeräte mit chemischer Desinfektion für
thermosensibles non critiques et des équipements de nicht kritische thermolabile Medizinprodukte und
soins de santé (ISO 15883-7:2025) Zubehör im Gesundheitswesen (ISO 15883-7:2025)
This European Standard was approved by CEN on 12 March 2025.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-7:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
This document (EN ISO 15883-7:2025) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2025, and conflicting national standards
shall be withdrawn at the latest by November 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15883-7:2016.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 15883-7:2025 has been approved by CEN as EN ISO 15883-7:2025 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation (EU) 2017/745 [OJ L 117] and to system or process requirements including those relating
to quality management systems, risk management, post-market surveillance systems, clinical
investigations, clinical evaluation or post-market clinical follow-up General Safety and Performance
Requirements of Regulation (EU) 2017/745
General Safety and
Clause(s) / sub-clause(s)
Performance Requirements Remarks / Notes
of this EN
of Regulation (EU) 2017/745
5(a) 4.1.3 The selected clause 4.1.3
partly covers the
requirement. Covered by
reduction of risks related to
damage the load during
operation.
Aspects related to the
environment in which the WD
is intended to be used are not
covered.
11.1 (d) 4.4, 4.7.2.3, 4.7.3 The selected clauses 4.4,
4.7.2.3, 4.7.3 partly covers
the requirement. Covered
with respect to preventing
microbial re-contamination
when using fluids for rinsing
process residue.
11.2 4.5 The selected clause 4.5 partly
covers the requirement.
Covered in respect of
preventing contamination of
the device.
14.2 (e) 4.7.2.3, 4.7.2.4 The selected clauses 4.7.2.3
and 4.7.2.4 partly cover the
requirement. Covered in
respect of avoiding
contamination of internal
piping.
18.8 4.1.4 The selected clause 4.1.4
partly covers the
requirement. Covered in
respect of unauthorized access
on the device.
23.4 (k) 8 a) – 8 j) Covered in respect of
documentation provided for
installation and safe operation
of the WD
Table ZA.2 — Applicable Standards to confer presumption of conformity as described in this
Annex ZA
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding
Clause 2 Standard Edition
European Standard
Edition
ISO 11139:2018 ISO 11139:2018 Sterilization of health care EN ISO 11139:2018
products — Vocabulary of terms
ISO ISO EN ISO
used in sterilization and related
11139:2018/Amd 11139:2018/Amd 11139:2018/A1:2024
equipment and process
1:2024 1:2024
standards
ISO 15883-1:2024 ISO 15883-1:2024 Washer-disinfectors — Part 1: EN ISO 15883-1:2025
General requirements, terms and
definitions and tests
ISO 15883-5:2021 ISO 15883-5:2021 Washer-disinfectors — Part 5: EN ISO 15883-5:2021
Performance requirements and
test method criteria for
demonstrating cleaning efficacy
IEC 61010-2- IEC 61010-2- Safety requirements for electrical EN IEC 61010-2-
040:2020 040:2020 equipment for measurement, 040:2021
control and laboratory use —
Part 2-040: Particular
requirements for sterilizers and
washer-disinfectors used to treat
medical materials
EN 10088-1 For applicable Stainless steels — Part 1: List of EN 10088-1:2023
standard edition see stainless steels
Column 4
EN 10088-2 For applicable Stainless steels — EN 10088-2:2024
standard edition see Part 2: Technical delivery

Column 4 conditions for sheet/plate and
strip of corrosion resisting steels
for general purposes
EN 12353:2021 For applicable Chemical disinfectants and EN 12353:2021
standard edition see antiseptics — Preservation of

Column 4 test organisms used for the
determination of bactericidal
(including Legionella),
mycobactericidal, sporicidal,
fungicidal and virucidal
(including bacteriophages)
activity
EN For applicable Chemical disinfectants and EN
13727:2012+A2:20 standard edition see antiseptics — Quantitative 13727:2012+A2:2015
15 Column 4 suspension test for the evaluation

of bactericidal activity in the

medical area — Test method and
requirements (phase 2, step 1)
The documents listed in the Column 1 of Table ZA.2, in whole or in part, are normatively referenced in
this document, i.e. are indispensable for its application. The achievement of the presumption of
conformity is subject to the application of the edition of Standards as listed in Column 4 or, if no
European Standard Edition exists, the International Standard Edition given in  Column 2 of Table ZA.2.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 1(12) of Regulation (EU) 2017/745, the following Table ZA.3
details the relevant Essential Health and Safety Requirements of Directive 2006/42/EC on Machinery to
the extent to which they are more specific than the General Safety and Performance Requirements set
out in Chapter II of Annex I of Regulation (EU) 2017/745 along with the corresponding clauses of this
European Standard. Table ZA.3, however, does not imply any citation in the OJEU under the machinery
directive and thus does not provide presumption of conformity for the machinery directive.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated
...