Technical Training

IEC 60601 & Medical Electrical Equipment Safety

Objectives

This 2-day online, IEC 60601 training offers a comprehensive introduction and advanced understanding of medical electrical equipment safety standards.
Participants will gain practical knowledge of methodologies, techniques, and industry terms necessary for successful regulatory approval, enhanced by expertise and real-world examples.

Learning Outcomes

Understand the fundamentals of IEC 60601.

• Learn industry-proven methods for implementing the standard.
• Develop practical skills through working examples and exercises.
• Gain the ability to apply analysis techniques for regulatory compliance.

Topics covered include:

• Risk Management & ISO 14971
• Essential Performance & Basic Safety
• Device Classification & Documentation
• Collateral & Particular Standards
• Protection Against Hazards (Electrical, Mechanical, Other)
• PEMS, Functional Safety & Cybersecurity
• ME Systems & EMC
• Risk Analysis & Isolation Diagrams
• Radiation & Battery Safety

Who should attend

Product safety engineers, compliance engineers, product designers, regulatory approval staff, production support engineers, quality assurance staff.
This course is suitable for delegates with no prior knowledge of IEC 60601 or can be customised for a more experienced audience.

Upcoming dates: