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 and the major news that has been introduced in the latest edition. 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
- Brief overview of market access around the world based on the 60601-series aspects
- 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
"I liked it gave an overview of the general standard and it's relation to collateral and particulars"
Participant, Fall 2016