Technical Training

IEC 60601 & Medical Electrical Equipment Safety

Objectives

This comprehensive 2-day virtual training offers a comprehensive understanding of the medical electrical equipment safety standards, enhanced by working examples, team exercises and our expert trainers industry knowledge and experience.
Participants will gain practical knowledge of the standard and the methodologies, techniques, and industry terms necessary for successful regulatory approval, On Day 2, participants will dive into the implementation and application of the IEC 60601 standard. You will be introduced to analysis techniques, methods and procedures proven in practice, using detailed IEC 60601 work 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.

Programme Outline

Day 1: Medical Electrical Equipment: Safety and Performance

• Risk management & relation to ISO 14971
• Definition of essential performance and basic safety
• Device classification
• Identification, marking and documents
• IEC 60601 relation to collateral & particular standards
• Protection against electrical hazards
• Protection against mechanical hazards
• Protection against other types of hazards
• PEMS and the relation to functional safety, IEC 62304 and cybersecurity
• Overview of collateral and particular standards
• ME systems considerations
• Electromagnetic compatibility (EMC)

Day 2: Methods and Techniques

• Comparison of risk analysis techniques based on device classification and technology
• Relationship to IEC 60664 and IEC 60112, pollution degree, transients altitude and CTI
• Generating isolation diagrams
• Electrical hazard test methods
• Radiation hazard analysis and techniques (including neutron and alpha)
• Battery safety in 60601
• Cybersecurity relating to hardware and 60601
• EMC techniques and practices
• Relationship to IEC 62353 for post release testing
• Detailed overview of 60601 particular standards
• Many worked examples based on 60601 projects
• A look ahead to the proposed changes in V4.0 of IEC 60601

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 and can be customised for a more experienced audience.

Upcoming dates: