“IEC 60601-1: Medical Electrical Equipment Safety” Seminar
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.
What you will achieve by attending the IEC 60601-1 seminar
The two-day seminar will provide you with a solid understanding of the standard so that you can
- develop safe medical devices that comply with standards,
- obtain approval without hassle or delays,
- consolidate your competence and skills, close gaps in your knowledge and thus
- develop safe products quickly and successfully.
Objectives
After attending this seminar, you will be able to:
- explain normative requirements and their applicability,
- reflect current changes (e.g., fourth edition, also of IEC 60601-1-2),
- understand how the IEC 60601 family interacts with other standards,
- define and correctly use terminology (e.g., Normal Condition, Single Fault Condition, Essential Performance and Basic Safety, MOOP, MOPP, PEMS, PESS),
- explain how to meet the safety and performance requirements of the Medical Devices Directive,
- assign safety concepts and measures to the hazard type and evaluate them,
- describe how the standard interacts with risk management,
- create isolation diagrams and
- document in compliance with IEC 60601-1.
Contents
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".
Time | Topic focus |
Day 1: |
|
9:00 AM | Start of seminar |
9:00 AM | Expectations, introduction |
9:30 AM | Family of standards and interaction with other standards, laws, directives, and other requirements |
10:30 AM | Break |
10:45 AM | Structure of the standard |
11:00 AM | Definitions of the terms Basic Safety, Normal Condition, Single Fault Safety, Essential Performance |
12:30 PM | Lunch |
1:00 PM | Case study: Determining Essential Performance characteristics and presentation |
2:30 PM | Break |
2:45 PM | Standard as a risk management file: Interaction with ISO 14971 |
3:00 PM | Types of hazards, defining acceptance criteria, dealing with probabilities, interaction with EMC and system architecture evaluation, documentation |
3:30 PM | Case study: Risk management (PHA, FTA) and EMC plan |
4:45 PM | Summary, questions, discussion |
5:00 PM | End |
Day 2: |
|
9:00 AM | Start |
9:00 AM | Brief recap, updated expectations |
9:30 AM | Introduction of general standard protection concepts, requirements, and terminology |
10:00 AM | Basics of electrical safety (standard concept, MOOP, MOPP, components, classification and evaluation, documentation, practical examples) |
10:30 AM | Break |
10:45 AM | Case study: Creating an isolation diagram |
11:30 AM | Software terms PEMS, PESS Requirements and Software safety classes |
12:30 PM | Lunch |
1:15 PM | Case study: Creating an architecture & safety concept and risk assessment |
2:30 PM | Break |
2:45 PM | Interaction of system architecture and software safety classes as well as essential performance characteristics |
3:00 PM | IEC 60601-1 4th edition and ISH1:2021 |
3:30 PM | Summary and open questions |
4:00 PM | Break |
4:15 PM | Learning test (participation optional) |
4:45 PM | Farewell |
5:00 PM | 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..
Target group
This seminar is intended for
- System and hardware architects who develop and evaluate systems,
- Embedded and software developers who want to understand the interaction between IEC 60601-1 and IEC 62304,
- Project managers who have to ensure the quality of the outputs,
- Risk managers who need to ensure the quality of the results
- Regulatory Affairs and Quality Managers who need to compile and assess documentation for regulatory approval.
The seminar is also suitable for those new to the subject.
You can find more information about next sessions, costs and registration here.
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