Overview
ISO 15883-6:2011 - Washer-disinfectors - Part 6 specifies particular requirements and tests for washer-disinfectors employing thermal disinfection intended for cleaning and disinfecting non-invasive, non-critical medical devices and healthcare equipment. It is intended to be used together with ISO 15883-1 (general requirements) and references test soils/methods in ISO/TS 15883-5. Thermal disinfection can be achieved by hot‑water rinsing, steam, or a combination, and the standard applies when an assurance level of disinfection of A0 not less than 60 is adequate and no independent automated critical‑process record is required.
Key topics and technical requirements
- Scope and device types: Targets reusable items that do not penetrate skin or mucosa (e.g., washbowls, buckets, trolleys, footwear, wheelchairs, crockery for immunocompromised patients).
- Cleaning performance: Cleaning tests are conducted per ISO 15883-1 using test soils and methods from ISO/TS 15883-5 relevant to the load.
- Washing temperature control: Washing temperature bands are defined with a lower limit (washing temperature) and an upper limit ≤ washing temperature + 10 °C; temperatures across load and chamber surfaces must remain within the band and not differ by more than 5 °C during washing.
- Thermal disinfection (A-value): Disinfection cycles must achieve A0 ≥ 60 on all load surfaces and chamber internal surfaces; selectable up to a maximum A0 of not less than 600.
- Temperature/time settings: Disinfection temperature preset range 65 °C to an upper limit ≥ 90 °C; disinfection time adjustable from 1 to at least 60 minutes. Surface temperatures must remain within 0 °C to +10 °C of the set disinfection temperature during the hold time.
- Controls and dosing: Dosing accuracy for process chemicals must be ±10% or better; adjustments protected by code/key/tool. Indicators or visibility for sufficient chemical supply and admission required.
- Process verification & testing: Independent visible display that shows chamber or load temperature attainment (separate from controller); thermometric tests and operational conformity testing follow ISO 15883-1 procedures with reference loads representing the heaviest, most heat‑resistant items.
Applications and users
- Practical for hospitals, clinics, dental and veterinary practices, laboratories, and healthcare laundry/catering areas where non-invasive, non-critical items require validated thermal cleaning + disinfection.
- Useful to medical device manufacturers, infection prevention teams, facility managers, QA personnel, and WD manufacturers specifying or validating washer‑disinfector performance for particular loads.
Related standards
- ISO 15883-1 (General requirements)
- ISO 15883-2, -3, -4 (other WD applications: surgical instruments, waste containers, endoscopes)
- ISO/TS 15883-5 (Test soils and cleaning efficacy methods)
Keywords: ISO 15883-6:2011, washer-disinfectors, thermal disinfection, A0 value, non-invasive non-critical devices, cleaning efficacy, thermometric tests, process verification.
Open preview (PDF)Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment