The IEC 60601 family of standards specifies requirements for medical electrical equipment. IEC 60601-1 is the most important standard in this family and defines the requirements for basic safety and essential performance characteristics of medical devices.
The two-day seminar will provide you with a solid understanding of the standard so that you can
After attending this seminar, you will be able to:
The seminar lasts two days and focuses on practical aspects. The lectures alternate between case studies and exercises. If requested, we will discuss your specific documents or product aspects and subject them to a "quick check".
Start of seminar
Family of standards and interaction with other standards, laws, directives, and other requirements
Structure of the standard
Definitions of the terms Basic Safety, Normal Condition, Single Fault Safety, Essential Performance
Case study: Determining Essential Performance characteristics and presentation
Standard as a risk management file: Interaction with ISO 14971
Types of hazards, defining acceptance criteria, dealing with probabilities, interaction with EMC and system architecture evaluation, documentation
Case study: Risk management (PHA, FTA) and EMC plan
Summary, questions, discussion
Brief recap, updated expectations
Introduction of general standard protection concepts, requirements, and terminology
Basics of electrical safety (standard concept, MOOP, MOPP, components, classification and evaluation, documentation, practical examples)
Case study: Creating an isolation diagram
Software terms PEMS, PESS Requirements and Software safety classes
Case study: Creating an architecture & safety concept and risk assessment
Interaction of system architecture and software safety classes as well as essential performance characteristics
IEC 60601-1 4th edition and ISH1:2021
Summary and open questions
Learning test (participation optional)
End of seminar
We limit the number to a maximum of 16 participants to ensure learning success and to have sufficient time for answering individual questions..
This seminar is intended for
The seminar is also suitable for those new to the subject.
You can find more information about next sessions, costs and registration here.