EN ISO 15883-5:2021

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
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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 .
...