Overview - ISO 15883-5:2021 (Washer‑disinfectors, Cleaning Efficacy)
ISO 15883-5:2021 specifies performance requirements and test‑method criteria to demonstrate the cleaning efficacy of washer‑disinfectors (WD) and their accessories used for cleaning reusable medical devices. The standard defines how to carry out both type testing (simulated use) and performance qualification (clinical use) soiled‑load tests, identifies relevant analytes and test soils, and sets expectations for visual and analytical acceptance. It applies also to WD used in dental, laboratory, pharmaceutical and veterinary contexts, but excludes prion verification and manufacturer internal device‑manufacturing activities.
Key technical topics and requirements
- Scope and terms: Defines key terms (e.g., load, test soil, analyte, alert/action level) and references ISO 15883‑1 and ISO 10993 series for biological evaluation.
- Test soils and load considerations: Guidance for selection and preparation of representative test soils and surrogate products to mimic clinical contamination.
- Cleaning efficacy test criteria: Requirements for visual examination, analytical assays (protein, haemoglobin and other analytes), and criteria for declaring items “clean.”
- Type testing vs performance qualification: Two‑phase approach - simulated type tests with defined test soils and clinical performance qualification with the most challenging clinical soils.
- Test method validation: Requirements for validating soiling methods, detection/sampling methods and analyte assays used for conformity testing.
- Process residuals and risk analysis: Assessment of residual detergents/chemicals, cytotoxicity considerations, sampling methods and acceptance criteria for residuals.
- Alert and action levels: Introduction of alert/action thresholds for analytes to support interpretation of cleaning validation.
- Informative and normative annexes: Includes examples of test soils (Annex A), a validated protein immersion test protocol and performance assessment (Annex B), protein and haemoglobin detection methods (Annex C & D) and sample worksheets (Annex E).
Practical applications - who uses ISO 15883-5
- Washer‑disinfector manufacturers for product design validation and type testing.
- Sterile processing departments (hospital CSSD/central sterilization) for qualification and routine performance verification.
- Independent testing laboratories performing conformity and cleaning validation tests.
- Regulatory and procurement teams assessing WD performance claims.
- Infection prevention and control specialists ensuring validated cleaning processes for reusable devices.
Related standards
ISO 15883‑5 is a practical reference for implementing robust cleaning validation programs for washer‑disinfectors, ensuring reproducible, auditable demonstration of cleaning efficacy for reusable medical devices.
Open preview (PDF)Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy