Validation of Process for Sterilisation and Sterile Barriers Systems - ISO 13485

Guarantee the effectiveness of sterilization and sterile barrier systems with our ISO 13485:2016 Clause 7.5 Validation of Processes for Sterilization & Sterile Barrier Systems Template. Sterilization and packaging validation are critical to ensuring medical devices remain sterile, safe, and effective throughout their lifecycle. This structured procedure template provides a systematic approach for planning, executing, and documenting sterilization validation, ensuring compliance with ISO 13485:2016, MDR, IVDR, FDA 21 CFR Part 820, ISO 14971, ISO 11135, ISO 11137, and ISO 11607.

✔ Pre-Formatted Sterilization & Sterile Barrier Validation Procedure – Covers key ISO 13485:2016 Clause 7.5 requirements.

✔ Sterilization Process Validation (IQ, OQ, PQ) – Ensure sterilization methods consistently meet regulatory requirements.

✔ Sterile Barrier System Validation – Verify packaging integrity, sealing strength, and material suitability.

✔ Risk Management & ISO 14971 Integration – Identify and mitigate potential contamination risks.

✔ Revalidation & Change Management Requirements – Ensure continued process control and effectiveness.

✔ Audit-Ready Documentation & Compliance Tracking – Maintain structured records for regulatory inspections.

✔ Approval & Sign-Off Workflow – Assign responsibilities for validation execution and review.

✔ Editable Digital Format – Fully customizable for different sterilization methods and packaging systems.

This ready-to-use sterilization validation template is essential for quality managers, validation engineers, and regulatory professionals, ensuring a structured, compliant, and effective validation process.

Download the ISO 13485:2016 Validation of Processes for Sterilization & Sterile Barrier Systems Template today and enhance your sterilization quality and compliance!