How to Design and Develop Fail-Safe Devices and Effectively Control Product Risk
Functional Safety is a key aspect of the conception, development and operation of safety-related control systems, particularly in regulated industries such as automotive, aerospace, railway technology and industrial automation.
To achieve and maintain Functional Safety, industry-specific standards such as ISO 26262, EN 50716, IEC 61511, and ISO 10218 are applied. Compliance with these standards is essential for the certification, approval, and market acceptance of products and systems in these sectors.
The overarching horizontal standard is IEC 61508, which provides the Safety Integrity Level (SIL) framework used to determine, implement, and verify the necessary safety measures.
For medical devices, the terminology and requirements of IEC 60601 are mandatory. Central to this framework are the concepts of essential performance and single-fault safety, which implement Functional Safety principles for the medical domain in alignment with the objectives of IEC 61508.
In this seminar, you will gain a comprehensive overview of the fundamental principles of Functional Safety and learn how to implement them in a practical and standards-compliant manner for medical devices.
- Content
- Fundamentals and Context
- Introduction and core concepts
- From fault to failure
- Faults and failures in a system
- Key metrics and definitions in the context of Functional Safety
- Methods and tools
- Regulatory framework / IEC 61508
- Essential Performance and Single-Fault Safety
- Motivation and rationale
- Functional Safety vs. Electrical Safety of medical devices according to IEC 60601-1
- Gaining a deeper understanding through Interpretation Sheet 1
- Practical Application
- Fundamentals and Context
- Your Benefits
- You’ll understand the fundamental principles and key metrics of functional safety.
- You will gain an overview of the normative requirements of IEC 61508.
- You will understand how essential performance and fail-safe design—with the help of current guidelines for IEC 60601—provide the success factors for developing a functionally safe design.
- You will learn how to integrate safety requirements into your development processes.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Developers and project managers in the medical technology sector
- Employees in quality management and regulatory affairs
- Individuals who design or are responsible for safety-critical systems, such as systems engineers and systems architects
- Risk managers and professionals
