ISO 11135/11137: Sterilization of Medical Devices (EtO / Radiation) Fundamentals Training by Tonex
Regulators expect clean, defensible sterilization programs that connect design intent, process capability, and patient safety. This course equips engineers, QA/RA leaders, and manufacturing teams to translate ISO 11135 (Ethylene Oxide) and ISO 11137 (Radiation) into practical, auditable work products—cycle design, validation, routine control, and change management. Because sterilization assets are now data-driven and network-connected, the integrity of batch records is a cybersecurity concern.
Compromised sensors, access control gaps, or altered audit trails can undermine sterility assurance and product release. You’ll learn how secure configurations, role-based access, and tamper-evident records protect patients while sustaining compliant, efficient sterilization operations.
Learning Objectives
- Explain scope, structure, and vocabulary of ISO 11135 and ISO 11137
- Map standard clauses to validation protocols, reports, and routine control evidence
- Develop EtO cycles and radiation doses using bioburden, D10, and SAL principles
- Build risk-based sampling plans and acceptance criteria that withstand audits
- Create end-to-end documentation sets for regulators and notified bodies
- Strengthen data integrity and cybersecurity within sterilization monitoring and release processes
Audience
- Quality Assurance Managers
- Process and Validation Engineers
- Regulatory Affairs Specialists
- Manufacturing and Operations Leaders
- Design and Development Engineers
- Cybersecurity Professionals
Course Modules
Module 1 – Standards Overview
- Scope and definitions alignment
- SAL concepts and targets
- Normative references mapping
- Roles and responsibilities
- Documentation expectations
- Common audit findings
Module 2 – EtO Principles
- Gas properties and safety
- Preconditioning fundamentals
- Moisture and humidity control
- Temperature and pressure strategy
- Aeration requirements and limits
- Material compatibility checks
Module 3 – Radiation Principles
- Gamma versus e-beam basics
- Dose setting methodologies
- Dose mapping and fixtures
- Bioburden and D10 linkage
- Dosimetry methods and control
- Material performance effects
Module 4 – Validation Lifecycle
- IQ, OQ, PQ deliverables
- Worst-case family selection
- Cycle development studies
- Performance qualification steps
- Requalification frequency rules
- Change management triggers
Module 5 – Routine Control
- Parametric release criteria
- In-process monitoring plans
- Nonconformance triage flow
- CAPA integration pathways
- Supplier and service oversight
- Trending and SPC dashboards
Module 6 – Risk and Data Security
- ISO 14971 risk linkage
- ALCOA+ data integrity controls
- Role-based system access
- Secure audit trails and e-signatures
- Backup, retention, recovery
- Remote support hardening
Ready to align your sterilization program with ISO 11135/11137 and protect critical records against cybersecurity threats? Enroll your team with Tonex to get actionable templates, checklists, and expert guidance tailored to your device portfolio and manufacturing reality.