EN 60601-series - 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.
- 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
- Hands-on training exercises
The course will be conducted in English.
Who should attend
The course is targeted at:
- Product development engineers
- Hospital engineers
- Regulatory affairs managers
- Project managers
- Quality managers
Ralf Gasser, Senior Consultant, Medidee Services SA
"I like that it started by giving an overview of the series and how to navigate it, and then continued getting more into details and also got into technical requirements. Even though I as QA engineer will not be making techical diagrams etc. it is nice to have had an introduction on how to work with them and how to understand them"
"I liked that Ralf was quite experienced and had ansvers ready at hand for most questions. The course material seemed very well organized"
"Structured, knowledgeable teacher"
"It gave a good overview of EN 60601"
Participants, Spring 2018