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)


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 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.............................................................................................................................................................................................................................. 54

© ISO 2021 – All rights reserved  iii