ISO 15883-5:2021
Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
4.1 General
4.2 Test soil considerations
4.3 Load considerations
4.4 Cleaning efficacy test criteria
4.4.1 General
4.4.2 Visual examination
4.4.3 Assay criteria
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)
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
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
5.5.2 Risk analysis
5.5.3 Cytotoxicity
5.5.4 Sampling methods
5.5.5 Acceptance criteria
Annex A (informative) Examples of test soils
Annex B (normative) Protein-based test soil performance assessment
Annex C (informative) Examples of test methods for the detection and assessment of residual proteinaceous contamination
Annex D (informative) Examples of test methods for the detection of haemoglobin for the assessment of cleaning efficacy
Annex E (informative) Test soil performance assessment – Sample results sheets
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
4.1 General
4.2 Test soil considerations
4.3 Load considerations
4.4 Cleaning efficacy test criteria
4.4.1 General
4.4.2 Visual examination
4.4.3 Assay criteria
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)
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
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
5.5.2 Risk analysis
5.5.3 Cytotoxicity
5.5.4 Sampling methods
5.5.5 Acceptance criteria
Annex A (informative) Examples of test soils
Annex B (normative) Protein-based test soil performance assessment
Annex C (informative) Examples of test methods for the detection and assessment of residual proteinaceous contamination
Annex D (informative) Examples of test methods for the detection of haemoglobin for the assessment of cleaning efficacy
Annex E (informative) Test soil performance assessment – Sample results sheets
Bibliography