ISO 13485 (Clause 7.5) - Medical Device Cleaning Record

Ensure accurate documentation and compliance for your medical device cleaning activities with our ISO 13485:2016 Clause 7.5 Medical Device Cleaning Record Template. Proper cleaning and maintenance of medical devices is crucial for ensuring product safety, performance, and regulatory compliance. This easy-to-use template provides a comprehensive record of all cleaning activities performed on your medical devices, ensuring that each cleaning process is thoroughly documented and traceable, as required by ISO 13485:2016.

✔ Pre-Formatted Cleaning Record Template – Fully aligned with ISO 13485:2016 Clause 7.5 for documenting cleaning activities.
✔ Cleaning Activity Details – Capture date, time, and personnel involved in each cleaning session.
✔ Device Identification – Track each device cleaned, including serial numbers and model information for full traceability.
✔ Cleaning Procedure & Materials Used – Document cleaning methods, agents, and tools used in each session.
✔ Verification & Inspection – Record post-cleaning inspections and effectiveness verification to ensure cleaning was successful.
✔ Audit-Ready Documentation – Maintain structured, organized records for internal audits and regulatory inspections.
✔ Editable Digital Format – Customizable for various devices and cleaning requirements.

This Medical Device Cleaning Record Template is ideal for quality managers, cleaning teams, and compliance officers, ensuring a systematic, compliant approach to documenting cleaning activities.

Download the ISO 13485:2016 Medical Device Cleaning Record Template today and ensure traceability, compliance, and effective cleaning practices!