Reprocessing of medical devices according to ISO 17664
The medical device regulation 2017/45, medical device directive 93/42 and ISO 17664 demand from manufacturers of reusable medical devices to provide instructions how to reprocess devices safely for the next use. The process described in these instructions has to be validated. This requirement ensures that a medical devices design allows a safe reprocessing. The obligation to validate processes in central sterile services departments of health care facilities remains unaffected by this.
We validate your processes so you can fulfil the requirements of ISO 17664 and state validated processes for reprocessing reusable medical devices.