SIST EN ISO 15883-3:2025

SLOVENSKI STANDARD
01-maj-2025
Nadomešča:
SIST EN ISO 15883-3:2009
Čistilno-dezinfekcijske naprave - 3. del: Zahteve in preskusi za čistilno-
dezinfekcijske naprave s toplotno dezinfekcijo za zbiralnike človeških izločkov
(ISO 15883-3:2024)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers (ISO 15883-3:2024)
Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für Behälter für
menschliche Ausscheidungen (ISO 15883-3:2024)
Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique de récipients à déjections humaines (ISO 15883-
3:2024)
Ta slovenski standard je istoveten z: EN ISO 15883-3:2025
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-3
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2025
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN ISO 15883-3:2009
English Version
Washer-disinfectors - Part 3: Requirements and tests for
washer-disinfectors employing thermal disinfection for
human waste containers (ISO 15883-3:2024)
Laveurs désinfecteurs - Partie 3: Exigences et essais Reinigungs-Desinfektionsgeräte - Teil 3:
pour laveurs désinfecteurs destinés à la désinfection Anforderungen an und Prüfverfahren für Reinigungs-
thermique de récipients à déjections humaines (ISO Desinfektionsgeräte mit thermischer Desinfektion für
15883-3:2024) Behälter für menschliche Ausscheidungen (ISO 15883-
3:2024)
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 15883-3:2025 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 15883-3:2025) 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 15883-3:2009.
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 15883-3:2024 has been approved by CEN as EN ISO 15883-3:2025 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(a) 4.3.2 The selected clause 4.3.2 partly
covers the requirement.
Covered by reduction of risks
related to use errors in
connection to ergonomic
features of the washer-
disinfectors (WDs).
Aspects related to the
environment in which the WD
is intended to be used are not
covered.
5(b) 7 a), 7 b), 7 d) The selected clauses 7 a), 7 b),
7 d) 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.
10.2 4.3.2, 4.3.3, 5.3.2, 5.3.3 The selected clauses 4.3.2,
4.3.3, 5.3.2, 5.3.3 partly cover
the requirement. 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
manufacturing and packaging
are not covered.
10,4,1, first paragraph 4.3.2, 4.3.3, 5.3.2, 5.3.3 The selected clauses 4.3.2,
4.3.3, 5.3.2, 5.3.3 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.
11.1 (c) 4.3.2, 4.3.3, 5.3.2, 5.3.3 The selected clauses 4.3.2,
4.3.3, 5.3.2, 5.3.3 partly cover
the requirement. Covered in
respect of reducing the risks of
any microbial leakage from the
device and/or microbial
exposure during use.
Aspects related to the WD
manufacturing processes are
not covered.
11.1 (d) 4.6, 4.7 The selected clauses 4.6, 4.7
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 5.2.1 The selected clause 5.2.1 partly
covers the requirement.
Covered with respect of design
of WD to facilitate its safe
cleaning and disinfection.
Aspects related to the WD re-
sterilization are not covered.

14.2 (a) 4.3.2, 4.3.3, 4.7 The selected clauses 4.3.2,
4.3.3 and 4.7 partly cover the
requirement in respect of
reducing the risks of injury, in
connection with WD physical
features, dimensional and
ergonomic features.
Aspects related to the WD
manufacturing are not
covered.
The risks of injury (through
spilling and discharge of
aerosols, hot load) are reduced
through design (automatic and
manual emptying, cooling).
14.2 (e) 5.3.2, 5.3.3 The selected clauses 5.3.2,
5.3.3 partly cover the
requirement in respect of
reducing the risks connected
with accidental ingress of
substances into the WD.
Aspects related to the WD
manufacturing are not
covered.
14.6 5.1.1 The selected clause 5.1.1 partly
covers the requirement.
Covered with respect to
ergonomics of the
measurement, monitoring and
display scales.
Aspects related to the WD
manufacturing are not
covered.
23.4 (k) 7 a) – e) The selected clause 7, first
sentence and 7a) – 7e) cover
the requirement.
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 15883-1 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
ISO 17664-2:2021 ISO 17664-2:2021 Processing of health care For applicable
products — Information to be standard edition see
provided by the medical device Column 2
manufacturer for the processing
of medical devices — Part 2:
Non-critical medical devices
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 15883-3
Second edition
Washer-disinfectors —
2024-11
Part 3:
Requirements an
...