IEC 60601-1 — Electrical Safety and Essential Performance Training by Tonex
Elevate your team’s mastery of IEC 60601-1, the global benchmark for medical electrical equipment safety and essential performance. This program clarifies risk management integration, verification and validation pathways, and documentation that regulators expect. You’ll translate dense clauses into actionable engineering and quality practices.
Cybersecurity intersects safety in modern devices; we spotlight how cyber threats can become safety hazards and how to design resilient architectures. Expect guidance on safeguarding essential performance against software misuse and connectivity risks. The result is confident conformity assessments, stronger audit readiness, and safer, more trustworthy medical technologies entering clinical environments.
Learning Objectives
- Interpret IEC 60601-1 structure, scope, and key terms
- Apply essential performance concepts to clinical use scenarios
- Execute risk control measures aligned with ISO 14971 processes
- Plan verification, validation, and test evidence for compliance
- Build robust technical files and usability traceability
- Coordinate safety activities across R&D, QA/RA, and suppliers
- Strengthen safety-by-design where cybersecurity affects essential performance
Audience
- Medical device engineers
- Quality and regulatory professionals
- Systems and software engineers
- Verification and validation specialists
- Product and compliance managers
- Clinical safety and risk leads
- Cybersecurity Professionals
Program Modules
Module 1 – Standard Foundations
- Scope and applicability
- Normative references map
- Terminology and definitions
- Essential performance basics
- Relationship to collateral parts
- Compliance strategy planning
Module 2 – Risk Management Integration
- ISO 14971 alignment
- Hazard identification methods
- Risk control selection
- Residual risk acceptability
- Benefit–risk documentation
- Linking to verification plans
Module 3 – Electrical Safety Controls
- Protective earth and leakage
- Dielectric strength criteria
- Creepage and clearance rules
- Thermal effects and limits
- Power supply considerations
- Single fault condition analysis
Module 4 – Mechanical and Environmental
- Enclosures and stability
- Moving parts hazards
- Vibration and shock limits
- Ingress protection choices
- Temperature and humidity ranges
- Transport and storage risks
Module 5 – Software and Programmable
- PEMS architecture expectations
- Software lifecycle alignment
- Essential performance monitoring
- Alarm and interlock behavior
- Update and patch management
- Documentation and traceability
Module 6 – Verification and Conformity
- Test plan architecture
- Sample size and rationales
- Test equipment calibration
- Evidence capture and traceability
- Deviation handling strategies
- Audit and Notified Body readiness
Ready to advance device safety and protect patients while accelerating market access? Enroll your team with Tonex to turn IEC 60601-1 requirements into reliable, repeatable engineering practice—delivering safer products, cleaner audits, and confident certifications.