Overview - EN ISO 15883-2:2025 (Washer-disinfectors, thermal disinfection)
EN ISO 15883-2:2025 specifies requirements and tests for washer‑disinfectors (WD) that employ thermal disinfection for reusable critical and semi‑critical medical devices. It covers WDs intended to perform both cleaning and thermal disinfection in a single operating cycle for items such as surgical instruments, anaesthetic equipment and accessory items (bowls, dishes, receivers, utensils, glassware). This European adoption of ISO 15883‑2:2024 supersedes the 2009 edition and is to be used together with ISO 15883‑1:2024 (general requirements), except where otherwise noted. Note: the standard states thermal processes cannot ensure removal/inactivation of prions (transmissible spongiform encephalopathies).
Key topics and technical requirements
- Performance requirements - overall criteria that a WD must meet for effective cleaning and thermal disinfection.
- Cleaning and disinfection testing - prescribed tests and performance checks to demonstrate efficacy in a single cycle.
- Temperature control and measurement - requirements for process temperatures and temperature of inner surfaces of processed devices to ensure adequate thermal exposure.
- Water quality - rules for water used during WD cycles, addressing microbiological and chemical suitability.
- Mechanical and control requirements - design, control systems and safety features that support consistent operation.
- Lumen and powered devices - special provisions for irrigation, flow through lumens and verification methods for devices with internal channels.
- Process verification and conformity testing - instructions for validating and demonstrating that WD performance meets the standard.
- Limitations and safety notes - explicit exclusions (e.g., prion inactivation not assured).
Applications and who uses this standard
EN ISO 15883‑2:2025 is essential for:
- Manufacturers of washer‑disinfectors designing, validating and declaring conformity of thermal WD equipment.
- Hospital sterile services/central sterile supply departments (CSSD) for procurement, validation and routine monitoring of WD processes.
- Biomedical engineers and validation teams performing installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
- Test laboratories and conformity assessors that perform required performance and safety tests.
- Regulatory and quality professionals aligning WD products and processes with EU Regulation (EU) 2017/745 (see Annex ZA).
Practical benefits include consistent cleaning/disinfection results, improved patient safety, demonstrable process validation and regulatory support.
Related standards
This part is to be used with:
- ISO 15883‑1:2024 - General requirements, definitions and tests (mandatory companion standard)
- ISO 15883‑5:2021 - Cleaning efficacy performance and test-method criteria
- ISO 17664‑1:2021 - Information for processing medical devices (critical & semi‑critical)
- Other normative references noted in Annex ZA (e.g., ISO 5361, ISO 5367, EN 10088‑2)
Keywords: EN ISO 15883-2:2025, washer-disinfectors, thermal disinfection, washer‑disinfector validation, ISO 15883, washer-disinfector requirements.
