BS EN ISO 15883-5:2021

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Washer-disinfectors – Performance requirements and test method criteria for demonstrating cleaning efficacy

Published By	Publication Date	Number of Pages
BSI	2021	50

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Categories: 11.080.10 - Sterilizing equipment, BSI

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Description

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.

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PDF Pages	PDF Title
2	National foreword
4	European foreword
6	Foreword
8	Introduction
9	1 Scope 2 Normative references 3 Terms and definitions
11	4 Performance requirements 4.1 General 4.2 Test soil considerations
12	4.3 Load considerations
13	4.4 Cleaning efficacy test criteria 4.4.1 General 4.4.2 Visual examination 4.4.3 Assay criteria
15	4.4.4 Process residuals 5 Testing for conformity 5.1 Cleaning test method validation 5.1.1 General 5.1.2 Load soiling method 5.1.3 Detection method(s)
16	5.1.4 Analyte assay method 5.2 Washer-disinfector requirements 5.3 Cleaning type test 5.3.1 Principle 5.3.2 Reagents/materials 5.3.3 Procedure 5.3.4 Acceptance criteria
17	5.4 Cleaning performance qualification test 5.4.1 Principle 5.4.2 Reagents/materials 5.4.3 Procedure 5.4.4 Acceptance criteria 5.5 Process residuals 5.5.1 General
18	5.5.2 Risk analysis 5.5.3 Cytotoxicity 5.5.4 Sampling methods 5.5.5 Acceptance criteria
19	Annex A (informative) Examples of test soils
25	Annex B (normative) Protein-based test soil performance assessment
47	Annex C (informative) Examples of test methods for the detection and assessment of residual proteinaceous contamination
52	Annex D (informative) Examples of test methods for the detection of haemoglobin for the assessment of cleaning efficacy
56	Annex E (informative) Test soil performance assessment – Sample results sheets
63	Bibliography

Additional information

Status	Definitive
Pages	50
Publication Date	2022-02-07
ISBN	978 0 539 21067 5
Standard Number	BS EN ISO 15883-5:2021
Title	Washer-disinfectors – Performance requirements and test method criteria for demonstrating cleaning efficacy
Identical National Standard Of	ISO 15883-5:2021, EN ISO 15883-5:2021
Corrects	BS EN ISO 15883-5:2021
Descriptors	Accessories, Washers, Cleaning, Test methods, Performance
Publisher	BSI
Committee	CH/198
ICS Codes	11.080.10 - Sterilizing equipment

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BS EN ISO 15883-5:2021

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