PD IEC TR 60601-4-5:2021

What is IEC TR 60601‑4‑5 about? 

IEC TR 60601‑4‑5 is one of the parts of a series of documents which is a Technical Report. IEC TR 60601-4-5 provides detailed technical specifications for security features of medical devices used in medical IT networks. Medical devices dealt with in this document include medical electrical equipment, medical electrical systems, and medical device software. medical device software, although not in the scope of IEC 60601 (all parts), can also make use of this document. 

The intent of IEC TR 60601-4-5 is to specify security capabilities that enable a medical device to be more easily integrated into a medical IT-network environment at a given security level.   

IEC TR 60601‑4‑5 applicable to medical devices with external data interface(s), for example when connected to a medical IT network or when a human interface is used for processing – e.g., entering, capturing, or viewing – confidential data. 

Note: IEC TR 60601‑4‑5 does not apply to other software used on a medical IT-network which does not meet the definition of medical device software. 

Note 2: An example of this exclusion is software not incorporated into the medical device. 

Note 3: IEC TR 60601‑4‑5 does also not apply to industry protocols such as DICOM and HL7. 

Who is IEC TR 60601‑4‑5 for? 

IEC TR 60601‑4‑5 on medical electrical equipment to: 

• Medical device manufacturers 
• Regulatory agencies and authorities 
• Research laboratories 
• Healthcare IT companies 
• Healthcare Software companies 
• Medical IT-network integrators 

Why should you use IEC TR 60601‑4‑5? 

The guidelines in IEC TR 60601‑4‑5 of security characteristics of medical devices used in medical IT networks, which is useful for the safety and security of confidential data in medical IT networks, which is important for protecting the medical data of patients and healthcare facilities. 

IEC TR 60601405 proposes recommendations for the security of confidential data for medical devices used in medical IT networks in a way that does not affect the medical device's safety and performance. 

IEC TR 60601405 helps identify the capability and security level of medical devices and specifies appropriate additional security countermeasures in the medical IT network. This increases the reliability and credibility of medical IT- network systems.