Content of-and Compliance to IEC TR 60601-4-5
- To get a thorough understanding of IEC TR 60601-4-5
- To be proficient in security levels
- To know how to currently test the security levels
The course is designed for various stakeholders within a medical device company:
- Security Specialist
- Quality Officer
- Regulatory Affairs Officer
- Manager
- Terms & Definitions
- Introduction & Motivation
- cl. 7 Mapping of requirements to capability security levels (SL-C)
- cl. 5 SECURITY LEVELS for the different foundational requirements
- cl. 6 Technical Description
- cl. 4 Common Security Constraints 60601-4-5 vs. MDCG vs. UL
- Conclusion
IEC TR 60601-4-5: Medical electrical equipment – Part 4-5: Guidance and interpretation – Safety-related technical security specifications.
There are many reasons why digital healthcare and medical devices must be thoroughly tested and secured. For some time now, more and more cybersecurity incidents have been occurring within the healthcare sector, leading to more legislation and regulations across the industry.
The IEC TR 60601-4-5 standard provides detailed technical information for security features in medical devices used in medical IT networks. This Technical Report released in 2021 addresses IT security for medical products in the scope of integrating them into IT networks, it defines a list of security requirements that should be considered from Hardware and Software prospective of the connected medical device.
This course will provide you with key knowledge behind theupcoming potentially harmonized device standard IEC TR 60601-4-5 for medicaldevice cyber security.
IEC TR 60601-4-5 defines a set of security requirement that should be fulfilled.
- You learn key points of IEC TR 60601-4-5
- You get a notified bodies point of view
Instructor-led in a virtual classroom.