Quality Management (QMS) 12 items
ISO 13485 Sterilization Process Validation Checklist (Clause 7.5.7)
A checklist for validating sterilization and sterile barrier system processes for medical devices under ISO 13485 Clause 7.5.7, referencing applicable process-specific standards.
ISO 13485:2016ISO 11135ISO 11137ISO 17665
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Validation Requirement
- Are sterilization and sterile barrier system processes validated prior to implementation and product realization? *
- Is the validation performed to the applicable process-specific standard (e.g., ISO 11135 for EO, ISO 11137 for radiation, ISO 17665 for moist heat)? *
- Are validation procedures documented, including acceptance criteria? *
Installation & Operational Qualification
- Has installation qualification (IQ) confirmed equipment is installed and operating per specification? *
- Has operational qualification (OQ) established process parameters and their acceptable ranges? *
- Are worst-case product loading configurations defined and challenged during qualification? *
Performance Qualification & Bioburden
- Has performance qualification (PQ) demonstrated the process consistently achieves the specified sterility assurance level (SAL)? *
- Is product bioburden monitored and controlled per the validated process? *
- Is the sterile barrier system (packaging) validated and integrity maintained through the shelf life? *
Records, Change & Revalidation
- Are records of validation results and conclusions retained as documented information? *
- Is revalidation performed when changes occur to product, process, equipment, or after a defined interval? *
- Are routine process monitoring and release records maintained for each sterilization load? *
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