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The international standard IEC 60601-1 describes the basic safety requirements for medical electrical devices and systems. In order to manufacture safe electrical medical products, these requirements must be taken into account during development. This implementation represents a challenge for many manufacturers.
The seminar includes the introduction to the standard, a detailed explanation of the most important points and, through examples and small workshops, conveys how the requirements can be put into practice.
topic overview
- Introduction to the safety philosophy of IEC 60601-1
- Concept of basic security and essential performance characteristics
- Integration of risk management according to ISO 14971 and usability according to IEC 62366-1
- Protection against electrical, mechanical and thermal hazards
- Practical solutions for the implementation of the requirements
- Examples for the implementation and documentation of the required evidence
target group
Developers, employees in quality management or regulatory affairs, risk managers.
previous knowledge
Not mandatory.
KONTAKT:
Online
