FprEN ISO 15883-6

Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (ISO/FDIS 15883-6:2025)

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht kritische Medizinprodukte und Zubehör im Gesundheitswesen (ISO/FDIS 15883-6:2025)

Dieses Dokument legt besondere Anforderungen an Reinigungs-Desinfektionsgeräte (RDGs) fest, die zur Verwendung vorgesehen sind, wenn der erforderliche Desinfektionssicherheitsgrad durch Reinigung und thermische Desinfektion (A0 nicht unter 60) erreicht werden kann und es nicht erforderlich ist, eine unabhängige automatisierte Dokumentation kritischer Prozesse durchzuführen. Es ist für die Anwendung im Zusammenhang mit ISO 15883 1 vorgesehen, wo allgemeine Anforderungen an Reinigungs-Desinfektionsgeräte festgelegt sind.
Der Produktbereich, für den Reinigungs-Desinfektionsgeräte dieses Typs verwendet werden können, ist auf Geräte und Zubehör beschränkt, die nichtinvasiv und nicht kritisch sind (d. h. die nicht in die Haut eindringen und keine Schleimhäute berühren).
ANMERKUNG   Die thermische Desinfektion kann durch Spülen der Beladung mit heißem Wasser, durch die Einwirkung von Dampf oder durch eine Kombination beider erreicht werden.
Dieses Dokument ist nicht anwendbar für kraftbetriebene Geräte, Lumeninstrumente und sonstige semikritische und kritische Medizinprodukte.
Geräte, die in den Anwendungsbereichen von ISO 15883 2, ISO 15883 3, ISO 15883 4 und ISO 15883 7 beschrieben sind, fallen nicht in den Anwendungsbereich des vorliegenden Dokuments.

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/FDIS 15883-6:2025)

L'ISO 15883-6:2011 spécifie les exigences particulières des laveurs désinfecteurs destinés à être utilisés lorsque le niveau d'assurance de désinfection nécessaire peut être obtenu par nettoyage et désinfection thermique (A0 au moins égal à 60) et ne nécessite pas que soit conservé un enregistrement automatique indépendant des procédés critiques. Elle est destinée à être utilisée conjointement à l'ISO 15883-1, qui donne des exigences générales pour les laveurs désinfecteurs.
La gamme de produits sur lesquels les laveurs désinfecteurs de ce type particulier peuvent être utilisés est limitée aux dispositifs et équipements non invasifs et non critiques (c'est-à-dire qui ne traversent pas la peau et qui ne sont pas en contact avec les muqueuses).

Čistilno-dezinfekcijske naprave - 6. del: Zahteve in preskusi čistilno-dezinfekcijskih naprav s toplotno dezinfekcijo za nenujne medicinske pripomočke in zdravstveno opremo (ISO/FDIS 15883-6:2025)

General Information

• Status: Not Published
• Publication Date: 22-Mar-2026
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 8 - Performance requirements and testing for washer-disinfectors
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 19-Dec-2025
• Completion Date: 19-Dec-2025
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: kSIST FprEN ISO 15883-6:2025 - Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (ISO/FDIS 15883-6:2025)

Relations

• Revises: EN ISO 15883-6:2015 - Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
• Effective Date: 21-Dec-2022

Overview - FprEN ISO 15883-6 (ISO/DIS 15883-6:2025)

FprEN ISO 15883-6 (ISO/FDIS 15883-6:2025) covers washer-disinfectors that employ thermal disinfection for non-critical medical devices and health care equipment. The standard specifies particular requirements and tests where cleaning plus thermal disinfection (A0 not less than 60) provides the necessary assurance of disinfection and where an independent automated record of critical processes is not required. It is intended to be used together with ISO 15883-1 (general requirements for washer-disinfectors).

Key topics and technical requirements

• Scope and device limits: Applies to non-invasive, non-critical items (e.g., laryngoscope handles, trays, bed frames, transport carts, wheelchairs) and excludes items covered by ISO 15883-2, -3, -4 and -7 (critical, semi‑critical, powered, lumened or thermolabile devices).
• Thermal disinfection criteria: Thermal disinfection can be achieved by hot-water rinsing, steam, or a combination; the standard requires an A0 value not less than 60.
• Performance and testing:
  • Cleaning efficacy tests carried out in triplicate per ISO 15883-1 using test methods and soils referenced in ISO 15883-5.
  • Thermometric tests to verify that temperatures on load surfaces, load carriers and chamber walls follow the disinfection temperature profile and fall within the permitted tolerance (see clause 4.3.4).
  • Tests for soil removal from chamber walls, load carriers and load.
• Mechanical and control requirements:
  • Control systems and process verification requirements to ensure repeatable cleaning/disinfection cycles.
• Water quality: Minimum water quality guidance is specified (clause 4.4); see ISO/TS 5111 for further guidance.
• Information and conformity: Manufacturer-supplied information, purchaser queries and conformity testing programmes are defined.

Practical applications and users

Who will use FprEN ISO 15883-6:

• Healthcare facilities (central sterile services, CSSDs) processing non-critical medical devices and reusable healthcare equipment.
• Manufacturers of washer-disinfectors designing units for thermal disinfection of non-critical items.
• Procurement teams, quality managers, and regulatory compliance specialists assessing WD performance for hospitals, dental clinics, laboratories, veterinary and long‑term care settings. Practical benefits include validated cleaning/disinfection cycles, product instructions for use, and alignment with regulatory expectations for non‑critical device reprocessing.

Related standards

• ISO 15883-1: General requirements, terms and tests for washer-disinfectors
• ISO 15883-5: Test methods and criteria for cleaning efficacy
• ISO 15883-2 / -3 / -4 / -7: Parts covering critical, waste, endoscopes, thermolabile devices (not applicable for this part)
• IEC 61010-2-040: Safety requirements for washer-disinfectors
• ISO/TS 5111: Guidance on water quality for WD

Keywords: FprEN ISO 15883-6, ISO 15883-6:2025, washer-disinfectors, thermal disinfection, non-critical medical devices, A0, cleaning efficacy, water quality.

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 15883-6:2025
01-april-2025
Čistilno-dezinfekcijske naprave - 6. del: Zahteve in preskusi čistilno-
dezinfekcijskih naprav s toplotno dezinfekcijo za nenujne medicinske pripomočke
in zdravstveno opremo (ISO/DIS 15883-6:2025)
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for noncritical medical devices and health care equipment (ISO/DIS
15883-6:2025)
Reinigungs-Desinfektionsgeräte - Teil 6: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für nicht kritische
Medizinprodukte und Zubehör im Gesundheitswesen (ISO/DIS 15883-6:2025)
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/DIS 15883-6:2025)
Ta slovenski standard je istoveten z: prEN ISO 15883-6
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-6:2025 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 15883-6:2025
oSIST prEN ISO 15883-6:2025
DRAFT
International
Standard
ISO/DIS 15883-6
ISO/TC 198
Washer-disinfectors —
Secretariat: ANSI
Part 6:
Voting begins on:
Requirements and tests for washer- 2025-02-03
disinfectors employing thermal
Voting terminates on:
2025-04-28
disinfection for noncritical medical
devices and health care equipment
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
ICS: 11.080.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 15883-6:2025(en)
oSIST prEN ISO 15883-6:2025
DRAFT
ISO/DIS 15883-6:2025(en)
International
Standard
ISO/DIS 15883-6
ISO/TC 198
Washer-disinfectors —
Secretariat: ANSI
Part 6:
Voting begins on:
Requirements and tests for washer-
disinfectors employing thermal
Voting terminates on:
disinfection for noncritical medical
devices and health care equipment
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
ICS: 11.080.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 15883-6:2025(en)
ii
oSIST prEN ISO 15883-6:2025
ISO/DIS 15883-6:2025(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 .3
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 carrier(s) 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
Annex ZA (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 8
Bibliography .11

iii
oSIST prEN ISO 15883-6:2025
ISO/DIS 15883-6:2025(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 different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products, in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/ TC 102,
Sterilizers and associated equipment for processing of medical devices, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 15883-6:2011), which has been technically
revised.
The main changes are as follows:
— change of title to reflect application to non-critical medical devices;
— addition of new terms defining critical and semi-critical medical devices, and non-critical devices;
— alignment of other terms and definitions with ISO 11139:2018+Amd 1:2024;
— revision of cross-references to relevant clauses in ISO 15883-1 and ISO 15883-5;
— the temperatures recorded on the surface of the load, load carrier(s) and chamber walls follow the
temperature profile specified for the disinfection stage and are within 0 °C and +10 °C as specified in 4.3.4;
— cleaning testing carried out in triplicate in accordance with ISO 15883-1 using the appropriate test
method(s) and test soil(s) as specified in ISO 15883-5;
— addition of water quality specified in 4.4;
— updating of Bibliography.
A list of all parts in the ISO 15883 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
oSIST prEN ISO 15883-6:2025
ISO/DIS 15883-6:2025(en)
Introduction
This document is the sixth part of the ISO 15883 series of standards specifying the general requirements
and performance of washer-disinfectors (WD). The requirements given in this document apply to WD used
for cleaning and thermal disinfection of non-critical medical devices (i.e. not penetrating skin or contacting
mucosal membranes) and for other items for use without further treatment in healthcare settings. Such
reusable equipment is cleaned and disinfected, but processing in a WD for surgical instruments (see
ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes (see ISO 15883-4), or for
non-critical thermolabile medical devices and health care equipment (see ISO 15883-7) is inappropriate or
impractical.
Some examples include
— non-critical medical devices (e.g. laryngoscope handles);
— washbowls;
— cleaning equipment (buckets);
— footwear;
— container systems used to transport medical devices, including trolleys and transport carts;
— bed frames, wheelchairs, aids for the disabled.
Fields of application within the scope of the ISO 15883 series can include laboratory, veterinary and dental
use, and other specific applications such as washer-disinfectors for the disinfection of crockery and cutlery
intended for use with immunologically compromised patients.
Requirements for washer-disinfectors for other applications are specified in other parts of ISO 15883.
The efficacy of disinfection can be impaired if soil removal is incomplete before the start of the disinfection
stage. It is desirable that manufacturers of washer-disinfectors be very clear about the items that can be
processed in the washer-disinfector, and that reference be made to the instructions for reprocessing
provided in the instructions for use of the items to be processed.
Safety requirements for washer-disinfectors are given in IEC 61010-2-040.
Guidance for the quality of water for use in a WD is given in ISO /TS 5111.
NOTE Local or national regulations can apply in respect of the potential adverse effects on the quality of water
intended for human consumption or environmental impacts caused by the WD and its intended use.

v
oSIST prEN ISO 15883-6:2025
oSIST prEN ISO 15883-6:2025
DRAFT International Standard ISO/DIS 15883-6:2025(en)
Washer-disinfectors —
Part 6:
Requirements and tests for washer-disinfectors employing
thermal disinfection for noncritical medical devices and
health care equipment
WARNING — Devices identified within the scope of ISO 15883-2, ISO 15883-3, ISO 15883-4 and
ISO 15883-7 shall not be processed in washer-disinfectors specified in this part of ISO 15883.
Examples of medical devices that are not to be processed in these washer-disinfectors include
powered devices, lumened devices and other semi-critical and critical medical devices.
1 Scope
This document specifies particular requirements for washer-disinfectors (WD) intended for use when the
level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A
not less than 60) and does not require an independent automated record of critical processes to be kept. It is
intended to be used in conjunction with ISO 15883-1, which specifies general requirements for WD.
The range of products on which WD of this particular type can be used is restricted to devices and equipment
which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).
NOTE Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam, or combination
of the two.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 15883-1:2024, Washer-disinfectors — Part 1: General requirements, terms and definitions and tests
ISO 15883-5, Washer-disinfectors — Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15883-1 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
critical medical device
item processed in a washer-disinfector, intended to be introduced directly into, or
have contact with, the vascular system or normally sterile areas of the body
EXAMPLE Surgical instruments.
oSIST prEN ISO 15883-6:2025
ISO/DIS 15883-6:2025(en)
Note 1 to entry: Critical medical devices will usually require sterilization before use.
Note 2 to entry: National regulations can use alternative wording for this term.
[SOURCE: ISO 11139:2018/Amd 1:2024, 3.333]
3.2
non-invasive device
device that does not penetrate inside the body, either through a body orifice or through the surface of the body
[SOURCE: ISO 11139:2018, 3.184]
3.3
non-critical device
item processed in a washer-disinfector, whose surface(s) are intended to contact
intact skin of a body but do not penetrate it, or device not intended for direct patient contact
EXAMPLE Blood pressure cuffs, wheelchairs, trays, bowls, dishes, glassware, receivers, containers for transit.
Note 1 to entry: National regulations can use alternative wording for the definition for this term when applied to
medical devices.
[SOURCE: ISO 11139:2018/Amd 1:2024, 3.357]
3.4
semi-critical medical device
item process
...