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prEN ISO 15883-7

(Main)

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024)

Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024)

ISO 15883-7:2016 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following:
a) bedframes;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs, aids for the disabled.
ISO 15883-7:2016 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.
Devices identified within the scopes of ISO 15883‑2, ISO 15883‑3, ISO I5883-4, and ISO 15883‑6 do not fall within the scope of this part of ISO 15883.
In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO/DIS 15883-7:2024)

Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection chimique des dispositifs médicaux thermosensibles non critiques et des équipements de soins de santé (ISO/DIS 15883-7:2024)

ISO 15883-7:2016 spécifie les exigences particulières relatives aux laveurs désinfecteurs (LD) destinés à être utilisés pour le nettoyage et la désinfection chimique, au cours d'un seul cycle standard, d'articles réutilisables tels que les suivants:
a) les cadres de lit;
b) les tables de chevet;
c) les chariots de transport;
d) les récipients;
e) les tables d'opération;
f) les récipients de stérilisation;
g) les sabots médicaux;
h) les fauteuils roulants et dispositifs auxiliaires pour les personnes handicapées.
ISO 15883-7:2016 spécifie également les exigences de performance relatives au nettoyage et à la désinfection du laveur désinfecteur ainsi que de ses composants et accessoires, qui peuvent être nécessaires pour atteindre les performances requises.
Les dispositifs identifiés dans les domaines d'application de l'ISO 15883‑2, l'ISO 15883‑3, l'ISO 15883‑4 et l'ISO 15883‑6 ne relèvent pas du domaine d'application de la présente partie de l'ISO 15883.
Le présent document spécifie également les méthodes, l'instrumentation et les instructions nécessaires pour les essais de type, les essais de fonctionnement, la validation (qualification de l'installation, qualification opérationnelle et qualification des performances lors de la première installation), le contrôle de routine et la surveillance, de même que les requalifications à effectuer périodiquement et après des réparations importantes.
NOTE Les LD relevant de la présente partie de l'ISO 15883 peuvent également être utilisés pour le nettoyage et la désinfection chimique d'autres dispositifs thermosensibles réutilisables, selon les recommandations du fabricant du dispositif.
Les exigences de performance spécifiées dans la présente partie de l'ISO 15883 ne peuvent pas garantir l'inactivation ou l'élimination du ou des agents pathogènes (protéine du prion) à l'origine des encéphalopathies spongiformes transmissibles.

Čistilno-dezinfekcijske naprave - 7. del: Zahteve in preskusne metode za čistilno-dezinfekcijske naprave s kemično dezinfekcijo za nekritične termolabilne medicinske pripomočke in zdravstveno opremo (ISO/DIS 15883-7:2024)

General Information

Status
Not Published
Publication Date
23-Apr-2025
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
4599 - Dispatch of FV draft to CMC - Finalization for Vote
Start Date
21-Aug-2024
Completion Date
21-Aug-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
oSIST prEN ISO 15883-7:2024 - Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO/DIS 15883-7:2024)

Relations

Revises
EN ISO 15883-7:2016 - Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
Effective Date
19-Jan-2023

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SLOVENSKI STANDARD
01-april-2024
Nadomešča:
SIST EN ISO 15883-7:2016
Čistilno-dezinfekcijske naprave - 7. del: Zahteve in preskusne metode za čistilno-
dezinfekcijske naprave s kemično dezinfekcijo za nekritične termolabilne
medicinske pripomočke in zdravstveno opremo (ISO/DIS 15883-7:2024)
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical devices and health care
equipment (ISO/DIS 15883-7:2024)
Reinigungs-Desinfektionsgeräte - Teil 7: Anforderungen und Prüfverfahren für
Reinigungs-Desinfektionsgeräte mit chemischer Desinfektion für nicht kritische
thermolabile Medizinprodukte und Zubehör im Gesundheitswesen (ISO/DIS 15883-
7:2024)
Laveurs désinfecteurs - Partie 7: Exigences et essais pour les laveurs désinfecteurs
destinés à la désinfection chimique des dispositifs médicaux thermosensibles non
critiques et des équipements de soins de santé (ISO/DIS 15883-7:2024)
Ta slovenski standard je istoveten z: prEN ISO 15883-7
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 15883-7
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2024-02-02 2024-04-26
Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical
devices and health care equipment
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 15883-7:2024(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 2024

ISO/DIS 15883-7:2024(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15883-7
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:

Washer-disinfectors —
Part 7:
Requirements and tests for washer-disinfectors employing
chemical disinfection for non-critical thermolabile medical
devices and health care equipment
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 2024
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 15883-7:2023(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

ISO/DIS 15883-7:2023(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Performance requirements . .2
4.1 General . 2
4.2 Cleaning . 3
4.3 Disinfection . 4
4.4 Final rinsing . 5
4.5 Self-disinfection . 5
4.6 Drying . 6
4.7 Water treatment equipment . 7
4.7.1 General . 7
4.7.2 Disinfection of water treatment equipment . 7
4.7.3 Maintenance of piping . 8
5 Mechanical requirements .8
5.1 Materials — Design, manufacture, and assembly . 8
5.2 Process verification . 8
6 Testing for conformity .8
6.1 General . 8
6.2 Test load . 8
6.2.1 Loading with standard goods . 8
6.2.2 Loading with special goods . 8
6.3 Final rinse water . 9
6.4 Load dryness . 9
6.4.1 General . 9
6.4.2 Procedure . 9
6.4.3 Results . 9
6.5 Thermometric tests . 9
6.5.1 General . 9
6.5.2 Load temperature test . . . 9
6.6 Chemical dosing tests . 9
6.6.1 General . 9
6.6.2 Reused process chemicals. 10
6.7 Tests of cleaning efficacy . 10
6.7.1 General . 10
6.7.2 Materials . 10
6.7.3 Procedure . 11
6.7.4 Results . 11
6.8 Test of disinfection efficacy . 11
6.8.1 General . 11
6.8.2 Preliminary tests on chemical disinfectants . 11
6.8.3 Self-disinfection tests .12
6.8.4 Chemical disinfection of the load . 13
7 Documentation .13
8 Information to be supplied .14
9 Marking, labelling, and packaging .14
10 Information to be requested from the purchaser by the WD supplier .14
Annex A (informative) Summary of test programmes .15
iii
ISO/DIS 15883-7:2023(E)
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid
transport system .17
Annex C (normative) Tests for microbiological contamination of final rinse water .22
Annex D (normative) Preparation and evaluation of indi
...

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