FprEN ISO 15883-7

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
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STANDARDS MAY ON OCCASION HAVE TO
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POTENTIAL TO BECOME STANDARDS TO
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WHICH REFERENCE MAY BE MADE IN
Reference number
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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
...