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kSIST FprEN ISO 15883-3:2024

(Main)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO/FDIS 15883-3:2024)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO/FDIS 15883-3:2024)

ISO 15883-3:2006 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle.
ISO 15883-3:2006 is to be applied in conjunction with ISO 15883-1.

Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für Behälter für menschliche Ausscheidungen (ISO/FDIS 15883-3:2024)

Dieses Dokument legt Anforderungen an Reinigungs-Desinfektionsgeräte (RDG) fest, die für die Entleerung, Ausspülung, Reinigung und thermische Desinfektion von Behältern für menschliche Ausscheidungen zur Entsorgung innerhalb eines Betriebszyklus angewandt werden.
Die in diesem Dokument festgelegten Anforderungen gelten zusätzlich zu den in ISO/DIS 15883 1:2020 und ISO 15883 5:2021 festgelegten allgemeinen Anforderungen.

Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients à déjections humaines (ISO/FDIS 15883-3:2024)

L'ISO 15883-3:2006 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour vider, rincer, nettoyer et désinfecter thermiquement les récipients employés pour contenir les déjections humaines afin de pouvoir les réutiliser après un cycle standard.
L'ISO 15883-3:2006 s'applique conjointement avec l'ISO 15883-1.

Čistilno-dezinfekcijske naprave - 3. del: Zahteve in preskusi za čistilno-dezinfekcijske naprave s toplotno dezinfekcijo za zbiralnike človeških izločkov (ISO/FDIS 15883-3:2024)

General Information

Status
Not Published
Public Enquiry End Date
16-Jul-2023
ICS
11.080.10 - Sterilizing equipment
Technical Committee
VAZ - Healthcare
Current Stage
5020 - Formal vote (FV) (Adopted Project)
Start Date
02-Sep-2024
Due Date
21-Oct-2024
Completion Date
02-Sep-2024
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
Ref Project
FprEN ISO 15883-3 - Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO/FDIS 15883-3:2024)

Relations

Revises
SIST EN ISO 15883-3:2009 - Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
Effective Date
18-Jan-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 15883-3:2023
01-julij-2023
Čistilno-dezinfekcijske naprave - 3. del: Zahteve in preskusi za čistilno-
dezinfekcijske naprave s toplotno dezinfekcijo za zbiralnike človeških izločkov
(ISO/DIS 15883-3:2023)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers (ISO/DIS 15883-3:2023)
Reinigungs-Desinfektionsgeräte - Teil 3: Anforderungen an und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit thermischer Desinfektion für Behälter für
menschliche Ausscheidungen (ISO/DIS 15883-3:2023)
Laveurs désinfecteurs - Partie 3: Exigences et essais pour laveurs désinfecteurs
destinés à la désinfection thermique de récipients à déjections humaines (ISO/DIS
15883-3:2023)
Ta slovenski standard je istoveten z: prEN ISO 15883-3
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN ISO 15883-3:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 15883-3:2023
oSIST prEN ISO 15883-3:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-3
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-04-24 2023-07-17
Washer-disinfectors —
Part 3:
Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
Laveurs désinfecteurs —
Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients à
déjections humaines
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 15883-3:2023(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 15883-3:2023
ISO/DIS 15883-3:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-3
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:

Washer-disinfectors —
Part 3:
Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
Laveurs désinfecteurs —
Partie 3: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermique de récipients à
déjections humaines
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 15883-3:2023(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 15883-3:2023
ISO/DIS 15883-3:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Performance requirements . .2
4.1 General . 2
4.2 Chemical dosing systems . 3
4.3 Emptying . 3
4.4 Cleaning . 4
4.5 Disinfecting . 4
4.6 Drying . 5
4.7 Cooling . 5
5 Mechanical and control requirements . 5
5.1 Instrumentation and control . 5
5.2 Process . 5
5.3 Venting, draining, and purging . 6
5.4 Water quality . 6
6 Testing for conformity .6
6.1 General . 6
6.2 Test for drain seal integrity . 6
6.3 Test for flushing of non-absorbent materials . 6
6.4 Test for flushing of absorbent material (toilet tissue) . 7
6.5 Test for loading/emptying of human waste containers . 7
6.5.1 Automatic emptying . 7
6.5.2 Manual emptying . 7
6.6 Tests for soil removal from load, load carrier(s) and chamber walls . 7
7 Information to be supplied . 7
8 Information to be requested from the purchaser by the supplier of the WD .8
Annex A (informative) Summary of test programmes . 9
Annex B (normative) Specification for toilet tissue for use in tests on washer-disinfectorsfor
human waste containers .10
Annex C (informative) Measurement of water absorbency of toilet tissue by the basket
method .11
Annex ZA (informative) Relationship between this European Standard the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .12
Bibliography .16
iii
oSIST prEN ISO 15883-3:2023
ISO/DIS 15883-3:2023(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 15883-3:2006), which has been
technically and editorially revised.
The main changes compared to the previous edition are as follows:
— revision of clauses cross-referencing clauses in ISO/DIS 15883-1:2020 and ISO 15883-5:2021;
— alignment of terms and definitions with ISO 11139:2018;
— addition of clause 4.1.2 listing exemptions from the requirements of ISO/DIS 15883-1:2020;
— alignment of text in clauses on cleaning and disinfecting with revised clauses of ISO 15883-2;
— addition of rinsing from former 4.6 to 4.4 Cleaning and 4.5 Disinfection
— addition of 4.7 Cooling;
— deletion of references in Bibliography already referenced in ISO/DIS 15883-1:2020 or
ISO 15883-5:2021.
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 15883-3:2023
ISO/DIS 15883-3:2023(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 third of a series of standards specifying the performance of washer-
disinfectors and
...

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