Understanding the IEC TR 60601-4-5: Medical Electrical Equipment

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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.

Complete the form and download the white paper to learn about IEC TR 60601-4-5, key aspects, and the importance of compliance. 


Topics covered in the whitepaper:

  • Understanding previous standards
  • Introducing IEC TR 60601-4-5 
  • Importance of complying with IEC TR 60601-4-5

ABout the author

Dr.-Ing. Abtin Rad, Global Director of Functional Safety, Software, and Digitization for Medical & Health Services at TÜV SÜDDr.-Ing. Abtin Rad

Global Director of Functional Safety, Software, and Digitization for Medical & Health Services at TÜV SÜD

Dr.-Ing. Abtin Rad is a member of the standardization committee for medical device IT security (60601-4-5). Abtin has co-authored the guidance document for cybersecurity provided by the interest group of notified bodies. He has 14 years of professional experience in the development of medical device software. Besides his work at TÜV SÜD, Abtin is an associate professor at the University of Applied Sciences in Hamburg for medical device software, medical imaging, and digital filter design topics.

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