IEC/TR 60601: Cyber Security for Medical Electrical Equipment

What does the IEC/TR 60601 Contain?

The DIN IEC/TR 60601-4-5 VDE 0750-4-5 provides recommendations and instructions for the safe and effective use of medical electrical equipment and systems. It contains information on certain applications that are not sufficiently covered by the standard IEC 60601-1:2014 + A1:2016 (Medical electrical equipment – Part 1: General requirements for cyber security, including the changes made by A2:2019). These special applications include, among others:

• Devices for near-electrosurgery
• Laser systems for surgical applications
• Magnetic resonance imaging (MRI) devices
• Electrocardiography (ECG) devices
• Devices for monitoring central nervous system functions

The standard also contains guidance on risk assessment and risk management for medical electrical equipment. It provides references to relevant standards, guidelines and publications for applying and complying with the required safety standards. The latest edition of the standard (2022-06) also contains updated information on new technologies and requirements in the field of medical electrical engineering.

What should be Considered in the Context of DIN IEC/TR 60601-4-5?

The following points should be noted:

1. Use of suitable devices and systems: The document contains recommendations for the use of medical electrical devices and systems that have been manufactured in accordance with the standard IEC 60601-1 + A1:2013 (see above).
2. Risk assessment and risk management: The application of the standard requires the performance of a risk assessment and the implementation of appropriate risk management measures for each individual device or system, as well as a technical review of the measures by means of a pentest.
3. Compliance with relevant standards: The standard refers to relevant standards and guidelines for the application of medical electrical devices and systems. Compliance with these requirements is necessary to ensure the safety and effectiveness of the application.
4. Training and instruction: It is important that specialist staff and users are appropriately trained and instructed to ensure the safe use of the devices and systems.
5. Updates and revisions: IEC 60601-4-5 is regularly updated to take account of new technologies and requirements in the field of medical electrical engineering. It is therefore important to ensure that the latest edition is taken into account in the application.