FprEN ISO 15883-2

SLOVENSKI STANDARD
oSIST prEN ISO 15883-2:2023
01-julij-2023
Čistilno-dezinfekcijske naprave - 2. del: Zahteve in preskusi za čistilno-
dezinfekcijske naprave s toplotno dezinfekcijo za kritične in polkritične
medicinske pripomočke (ISO/DIS 15883-2:2023)
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)
Reinigungs-Desinfektionsgeräte - Teil 2: Anforderungen und Prüfverfahren von
Reinigungs-Desinfektionsgeräten mit thermischer Desinfektion für kritische und
semikritische Medizinprodukte (ISO/DIS 15883-2:2023)
Laveurs désinfecteurs - Partie 2: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique des dispositifs médicaux critiques et semi-critiques
(ISO/DIS 15883-2:2023)
Ta slovenski standard je istoveten z: prEN ISO 15883-2
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 15883-2:2023
oSIST prEN ISO 15883-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-24 2023-07-17
Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical
devices
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15883-2:2023(E)
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. © ISO 2023

oSIST prEN ISO 15883-2:2023
ISO/DIS 15883-2:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-2
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:

Washer-disinfectors —
Part 2:
Requirements and tests for washer-disinfectors employing
thermal disinfection for critical and semi-critical medical
devices
ICS: 11.080.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 15883-2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 15883-2:2023
ISO/DIS 15883-2:2023(E)
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 . 4
4.3 Disinfecting . 5
4.4 Temperature of inner surfaces of processed devices . 5
4.5 Water quality . 5
5 Mechanical and control requirements . 5
5.1 Lumen and powered devices . 5
5.1.1 Irrigation . 5
5.1.2 Verification of flow through lumen and powered devices . 6
5.2 Control systems . 6
5.3 Process verification . 7
6 Testing for conformity .7
6.1 General . 7
6.2 Tests for soil removal from chamber walls, load carrier(s) and load . 7
6.3 Thermometric tests . 7
6.3.1 General . 7
6.3.2 Temperature of outer surfaces of devices . 7
6.3.3 Temperature of inner surfaces of devices . 8
6.4 Pressure and flow measurement . 9
7 Information to be supplied for the WD . 9
8 Information to be requested from the purchaser by the supplier of the WD .10
Annex A (informative) Summary of test programmes .11
Annex B (informative) Guidance on the designation of a medical device to a product family
for cleaning and thermal disinfection processes .12
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .15
Bibliography .19
iii
oSIST prEN ISO 15883-2:2023
ISO/DIS 15883-2:2023(E)
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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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.
This second edition cancels and replaces the first edition (ISO 15883-2:2006), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— change to title to reflect application to critical and semi-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;
— revision of cross-references to relevant clauses in ISO/DIS 15883-1:2020 and ISO 15883-5:2021;
— the upper limit of the washing temperature band reduced to +5 °C;
— addition of a clause on water quality (see 4.5);
— clarification of requirements for lumen and powered devices (see 5.1);
— addition of informative Annex B providing guidance on assigning a medical device to a product
family for cleaning and thermal disinfection processes;
— revision of references in 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 15883-2:2023
ISO/DIS 15883-2:2023(E)
Introduction
It is recommended that this Introduction be read in conjunction with the Introduction to ISO/DIS 15883
1:2020.
This part of ISO 15883 is the second of a series of standards specifying the performance of washer-
disinfectors and specifies the general requirements for performance applicable to instrument washer-
disinfectors. The requirements given in this document apply to washer-disinfectors (WD) used for
cleaning and thermal disinfection of critical and semi-critical medical devices intended for reuse such
as:
— surgical instruments, which are divided into instrument product families based on design features,
e.g. instruments without hinges, cavities or lumens, with hinges, with sliding shafts, with lumens,
microsurgical instruments, and complex instruments (e.g. robotic);
— powered instruments;
— anaesthetic and respiratory equipment;
— medical devices comprised of glass components;
— any non-critical devices used in conjunction with critical and semi-critical medical devices.
Requirements for washer-disinfectors for other applications, such as for processing non-critical devices
and thermolabile endoscopes, are specified in
...