ISO 17664 – Manufacturer information for medical devices

Do you need to ensure your reprocessing instructions work in practice? This helps you check reproducibility and build documentation that supports submissions and audits.

If your medical device is intended to be reprocessed, your instructions for use must describe validated reprocessing steps. EN ISO 17664 requires manufacturer information that enables effective, reproducible cleaning, disinfection and, where applicable, sterilisation. We assess the processes described in your instructions and consider related standards where relevant (e.g., EN ISO 15883, EN ISO 17665, EN ISO 10993). This strengthens documentation for submissions and audits and reduces patient and user risk. You receive a digitally signed test report with a professional assessment..

Link: https://www.hygcen.de/en/services/manufacturer-information-for-medical-devices-en-iso-17664.html