ISO 15883-5:2021 specifies performance requirements and test method criteria to demonstrate cleaning efficacy of washer‑disinfectors (WDs) and their accessories intended for cleaning reusable medical devices. It sets out how to select test soils and loads, how to perform type testing and performance qualification, and how to assess residual contaminants (e.g., protein, haemoglobin). Note: the standard can also be applied to washer‑disinfectors used in dental, laboratory, pharmaceutical and veterinary contexts, but does not apply to activities performed by manufacturers of reusable medical devices.
Keywords: washer-disinfectors, cleaning efficacy, ISO 15883-5, washer disinfector validation, cleaning validation.
Key technical topics and requirements
- Scope and definitions: Harmonized terminology aligned with ISO 11139:2018 for consistent interpretation.
- Performance requirements: Defined criteria for demonstrating cleaning under simulated (type test) and clinical (performance qualification) conditions.
- Test soils and load considerations: Guidance on selecting representative soils and instrument loads for realistic evaluation; Annex A gives example test soils.
- Acceptance and assay criteria:
- Visual examination requirements
- Quantitative assay thresholds for analytes (e.g., residual protein and haemoglobin)
- Introduction of alert and action levels to interpret validation data
- Test method validation and conformity assessment:
- Validation of cleaning test methods, detection methods and analyte assays
- Type testing and cleaning performance qualification procedures (principles, reagents, procedures, acceptance criteria)
- Process residuals and safety:
- Risk analysis, cytotoxicity considerations, sampling methods and acceptance criteria for residuals
- Informative and normative annexes:
- Annex B: immersion test protocol for protein‑based test soil
- Annex C/D: examples of protein and haemoglobin detection methods
- Annex E: sample result worksheets
Practical applications - who uses this standard
- Washer‑disinfector manufacturers - to develop, test and certify equipment performance.
- Clinical sterilization/CSSD teams - to validate cleaning cycles and ensure reusable devices are effectively cleaned before disinfection/sterilization.
- Testing and accreditation laboratories - to perform type tests, performance qualification and conformity assessments.
- Regulators and procurement teams - to define performance requirements in specifications and tender documents.
- Healthcare, dental, laboratory and veterinary facilities - when selecting and qualifying washer‑disinfectors for instrument reprocessing.
Related standards
- Other parts of the ISO 15883 series (washer‑disinfectors) and ISO 11139:2018 (terminology harmonization) are relevant for comprehensive validation and compliance.
This standard is essential for anyone involved in washer‑disinfector validation, cleaning efficacy testing, or procurement of reprocessing equipment.
