EN ISO 15883-5:2021

Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices.
NOTE 1   The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2   This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.

Reinigungs-Desinfektionsgeräte - Teil 5: Leistungsanforderungen und Kriterien für Prüfverfahren zum Nachweis der Reinigungswirksamkeit (ISO 15883-5:2021)

Dieses Dokument legt Verfahren und Prüfmethoden fest, die zum Nachweis der Reinigungswirksamkeit von Reinigungs-Desinfektionsgeräten (RDG) und ihres Zubehörs, die für die Reinigung von wiederverwendbaren Medizinprodukten eingesetzt werden, angewendet werden sollen.
ANMERKUNG 1 Die Anforderungen können auf Reinigungs-Desinfektionsgeräte angewendet werden, die zur Verwendung mit anderen Gegenständen bestimmt sind, die im Rahmen der medizinischen, zahnmedizinischen, labortechnischen, pharmazeutischen und veterinärmedizinischen Praxis verwendet werden.
ANMERKUNG 2 Dieses Dokument ist nicht anzuwenden für die Tätigkeiten, die von den Herstellern von wiederverwendbaren Medizinprodukten durchzuführen sind.

Laveurs désinfecteurs - Partie 5: Exigences de performance et critères des méthodes d’essai pour démontrer l’efficacité du nettoyage (ISO 15883-5:2021)

Le présent document spécifie les modes opératoires et les méthodes d’essai utilisés pour démontrer l’efficacité du nettoyage des laveurs désinfecteurs (LD) ainsi que de leurs accessoires destinés à être utilisés pour nettoyer des dispositifs médicaux réutilisables.
NOTE 1      Les exigences peuvent être utilisées pour les laveurs désinfecteurs destinés à être utilisés avec d’autres articles utilisés dans le contexte d’activités médicales, dentaires,laboratoires,  pharmaceutiques et vétérinaires.
NOTE 2      Le présent document ne s’applique pas aux activités à effectuer par les fabricants de dispositifs médicaux réutilisables.

Čistila - 5. del: Zahtevane lastnosti in merila preskusnih metod za prikaz učinka čiščenja (ISO 15883-5:2021)

General Information

• Status: Published
• Publication Date: 17-Aug-2021
• Withdrawal Date: 27-Feb-2022
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 18-Aug-2021
• Completion Date: 18-Aug-2021
• 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15883-5:2021 - Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)

Relations

• Replaces: CEN ISO/TS 15883-5:2005 - Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy (ISO/TS 15883-5:2005)
• Effective Date: 25-Aug-2021

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2021
Nadomešča:
SIST-TS CEN ISO/TS 15883-5:2006
Čistila - 5. del: Zahtevane lastnosti in merila preskusnih metod za prikaz učinka
čiščenja (ISO 15883-5:2021)
Washer-disinfectors - Part 5: Performance requirements and test method criteria for
demonstrating cleaning efficacy (ISO 15883-5:2021)
Reinigungs-Desinfektionsgeräte - Teil 5: Leistungsanforderungen und Kriterien für
Prüfverfahren zum Nachweis der Reinigungswirkung (ISO 15883-5:2021)
Laveurs désinfecteurs - Partie 5: Exigences de performance et critères des méthodes
d’essai pour démontrer l’efficacité du nettoyage (ISO 15883-5:2021)
Ta slovenski standard je istoveten z: EN ISO 15883-5:2021
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15883-5
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2021
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes CEN ISO/TS 15883-5:2005
English Version
Washer-disinfectors - Part 5: Performance requirements
and test method criteria for demonstrating cleaning
efficacy (ISO 15883-5:2021)
Laveurs désinfecteurs - Partie 5: Exigences de Reinigungs-Desinfektionsgeräte - Teil 5:
performance et critères des méthodes d'essai pour Leistungsanforderungen und Kriterien für
démontrer l'efficacité du nettoyage (ISO 15883- Prüfverfahren zum Nachweis der Reinigungswirkung
5:2021) (ISO 15883-5:2021)
This European Standard was approved by CEN on 28 February 2021.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15883-5:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 15883-5:2021) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2022, and conflicting national standards
shall be withdrawn at the latest by February 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 15883-5:2005.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15883-5:2021 has been approved by CEN as EN ISO 15883-5:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 15883-5
First edition
2021-07
Washer-disinfectors —
Part 5:
Performance requirements and test
method criteria for demonstrating
cleaning efficacy
Laveurs désinfecteurs —
Partie 5: Exigences de performance et critères des méthodes d’essai
pour démontrer l’efficacité du nettoyage
Reference number
ISO 15883-5:2021(E)
©
ISO 2021
ISO 15883-5:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 15883-5:2021(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Performance requirements . 3
4.1 General . 3
4.2 Test soil considerations . 3
4.3 Load considerations . 4
4.4 Cleaning efficacy test criteria . 5
4.4.1 General. 5
4.4.2 Visual examination . 5
4.4.3 Assay criteria . 5
4.4.4 Process residuals . 7
5 Testing for conformity . 7
5.1 Cleaning test method validation . 7
5.1.1 General. 7
5.1.2 Load soiling method . 7
5.1.3 Detection method(s) . . 7
5.1.4 Analyte assay method . 8
5.2 Washer-disinfector requirements . 8
5.3 Cleaning type test . 8
5.3.1 Principle . 8
5.3.2 Reagents/materials . 8
5.3.3 Procedure . 8
5.3.4 Acceptance criteria . 8
5.4 Cleaning performance qualification test . 9
5.4.1 Principle . 9
5.4.2 Reagents/materials . 9
5.4.3 Procedure . 9
5.4.4 Acceptance criteria . 9
5.5 Process residuals . 9
5.5.1 General. 9
5.5.2 Risk analysis .10
5.5.3 Cytotoxicity .10
5.5.4 Sampling methods .10
5.5.5 Acceptance criteria .10
Annex A (informative) Examples of test soils .11
Annex B (normative) Protein-based test soil performance assessment .16
Annex C (informative) Examples of test methods for the detection and assessment of
residual proteinaceous contamination .38
Annex D (informative) Examples of test methods for the detection of haemoglobin for the
assessment of cleaning efficacy .43
Annex E (informative) Test soil performance assessment – Sample results sheets .47
Bibliography .
...