SIST EN ISO 15883-1:2025

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 Claus
...