IEC 60601 – How to Apply Safety and Risk Management to Medical Electrical Equipment and Systems
How to apply safety and risk management to medical electrical equipment and systems.
Course objective and outcome
The objective is to create a general understanding of the EN 60601-series, which is the product standard series for electrical medical devices and system. The course will cover the structure of the series, how to use and interpret it in a proper way. It will also cover the relation to the European market and other important markets around the world. Hands-on training sessions will be applied throughout the course. The course is based on a practical rather than theoretical viewpoint.
Content
- General overview of the standard series including structure and relations
- How to use and interpret the standard series
- Relation to legislation in Europe and around the world
- Safety philosophy
- Risk analysis
- Requirements for construction and test methods
- Review of §4-17 in basic standard EN 60601-1
- Systems
- Usability
- Hands-on training exercises
Who should attend
The course is targeted at:
- Manufacturers
- Product development engineers
- Hospital engineers
- Regulatory affairs managers
- Project managers
- Quality managers
Trainer
Yannick Charrotton
CEO & Founder, Lambda Health System
Yannick Charrotton combines an engineering background with practical experience in developing and commercialising medical technology. On this course, he guides participants through the structure and practical application of the IEC/EN 60601 series, including safety philosophy, risk analysis, construction requirements, test methods, systems and usability. His teaching focuses on translating the standards into practical decisions throughout product development and compliance work.
What previous participants said
Contact
Select date
1-2 oktober 20261-2 februar 2027
29-30 september 2027
1-2 October 2026 - at 09:00 - 16:10
Price ex. VATLatest Registration
24 September 2026
Latest Cancellation
10 September 2026
Bøge Allé 5, 2. th
2970 Hørsholm
View Program
Terms
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