ISO 15883-2:2024

Overview

ISO 15883-2:2024 - "Washer‑disinfectors - Part 2" specifies requirements and test methods for washer‑disinfectors (WD) that use thermal disinfection to process reusable critical and semi‑critical medical devices (for example, surgical instruments, anaesthetic equipment, and associated non‑critical items such as bowls and glassware). It is the second edition, intended to be used together with the general requirements in ISO 15883‑1:2024. The standard clarifies performance, verification and testing for cleaning and thermal disinfection in a single operating cycle and notes that it does not guarantee removal/inactivation of prion agents.

Key topics and technical requirements

• Scope and device types: Applies to critical and semi‑critical medical devices, powered instruments, anaesthetic/respiratory equipment and non‑critical items used with them.
• Performance requirements: Specifies cleaning and thermal disinfection performance criteria (soil removal, maintained process variables, and limitations related to prions).
• Temperature control and thermometry: Requirements and tests for temperature of device outer and inner surfaces, and for defining and verifying the washing temperature band. (The 2024 revision adjusted the washing temperature band limit.)
• Lumen and powered device handling: Special requirements for irrigation, flow verification through lumens and verification of powered devices.
• Water quality: New clause addressing water quality requirements relevant to cleaning/disinfection performance and environmental/regulatory impacts.
• Mechanical and control systems: Requirements for control systems, dosing accuracy (noting certain exceptions), process monitoring and verification.
• Testing for conformity: Defined test programmes for soil removal, thermometric tests, pressure and flow measurements and worst‑case validation.
• Documentation: Information the WD supplier must provide and information purchasers should request; Annex B gives guidance on assigning devices to product families for processing.

Practical applications - who uses this standard

• Manufacturers of washer‑disinfectors - to design, validate and document compliance for thermal WD models.
• Sterile Processing Departments (SPD) in hospitals and clinics - to select appropriate WD cycles and validate processes for surgical and semi‑critical devices.
• Medical device manufacturers - to provide processing instructions consistent with ISO 17664 series and align device families for WD processing.
• Test laboratories and conformity assessors - to run the standardized test programmes for performance verification.
• Regulators and procurement specialists - to specify requirements in purchasing and compliance frameworks.

Related standards

• ISO 15883‑1:2024 (general requirements)
• ISO 15883‑5:2021 (cleaning efficacy criteria)
• ISO 17664‑1:2021 (processing information from device manufacturers)
• IEC 61010‑2‑040 (safety requirements for WD)
• ISO 11139 (terms and definitions referenced)

Keywords: ISO 15883‑2:2024, washer‑disinfectors, thermal disinfection, critical medical devices, semi‑critical devices, cleaning efficacy, lumen irrigation, process verification.