What the ISO 15883 series covers
ISO 15883 sets requirements and tests for washer-disinfectors that clean and disinfect reusable medical devices and related items. Part 1 holds the general requirements, terms and test methods. Each later part adds requirements for one kind of load (ISO).
| Part | Load or topic |
|---|---|
| Part 1 | General requirements, terms and test methods |
| Part 2 | Thermal disinfection of surgical instruments, anaesthetic equipment, bowls, dishes and similar items |
| Part 3 | Thermal disinfection of human waste containers, such as bedpans |
| Part 4 | Chemical disinfection of heat-sensitive (thermolabile) endoscopes |
| Part 5 | Test soils and methods for showing cleaning efficacy |
| Parts 6 and 7 | Thermal and chemical disinfection of non-invasive, non-critical items |
The A0 value in a tender
ISO 15883 expresses thermal disinfection as an A0 value: the lethality of a time-temperature profile, stated as equivalent seconds at 80 °C. A higher A0 means a more lethal process. Tenders often name the A0 they want for each load, so check that your programme reaches it, at the temperature and hold time your datasheet states.
Typical tender parameters for a washer-disinfector
| Tender line | What to check in your datasheet |
|---|---|
| Load type and ISO 15883 part | Which parts your machine is tested to, for which loads |
| Capacity | Number of DIN trays or load carriers per cycle, and chamber size |
| Single or double door | Pass-through (barrier) design between dirty and clean sides, if asked |
| Disinfection | A0 value, disinfection temperature and hold time per programme |
| Cycle time | Whether the tender's cycle time includes drying, and for which load |
| Chemicals and dosing | Number of dosing pumps, dose monitoring, and which detergents are qualified |
| Water | Final-rinse water quality, water consumption and supply connections |
| Records and traceability | Process records, printer or data interface, and batch traceability |
| Tests and documents | Factory and site tests, and the validation documents to hand over |
How to check a hospital tender against your washer-disinfector datasheet
- List every requirement in the tender schedule, specification and any national guidance it names.
- Match each requirement to the line in your datasheet or standard offer that answers it, with the page.
- Mark each one compliant, deviation or clarification, and write why.
- Price the extras: load carriers, extra dosing, witnessed tests and validation support.
Write each gap as a row in your technical deviation list, and keep the full list in an engineering compliance matrix. OdysseyGPT drafts both from the tender package and your datasheets, with a quote and page for each row, for an engineer to check. It reads PDF, Word and Excel files, not drawings. See OdysseyGPT for manufacturing.