prEN ISO 15883-6
(Main)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)
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)
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/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)
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/DIS 15883-6:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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Reference number
ISO/DIS 15883-6:2025(en)
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
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Published in Switzerland Reference number
ISO/DIS 15883-6:2025(en)
ii
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
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
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 washe
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