Reprocessing - Related International Standards
The following non-harmonised international standards are related to Reprocessing for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices | active | 11, 23 | Link |
| ISO 17664-2:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices | active | 11, 23 | Link |
| ISO 15883-1:2025 | Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024) | active | 11, 11.2, 11.5 | Link |
| ISO 15883-2:2025 | Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO 15883-2:2024) | active | 11, 11.2, 11.5 | Link |
| ISO 15883-3:2024 | Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024) | active | 11, 11.2, 11.5 | Link |