IEC TR 60601-4-5
IEC TR 60601-4-5 Medical Electrical Equipment — Security Specifications — IEC SC 62A
Also known as: IEC TR 60601-4-5, IEC 60601-4-5, IEC TR 60601-4-5:2021, 60601-4-5
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At a glance
- Status
- In force
- Next deadline
- None announced
- Who must comply
- Medical devices with external data interfaces, such as those connected to a medical IT network: medical electrical equipment, medical electrical systems and medical device software. In-vitro diagnostic devices are excluded. source
- How it is assessed
- A Technical Report of guidance and interpretation; a device's security capability level (SL-C) is matched to the target security level (SL-T) of the network it joins. source
- Written by
- A Technical Report of the IEC, prepared by subcommittee SC 62A (common aspects of medical equipment, software and systems) of TC 62. source
- Last change
- None recorded yet
The technical report that specifies security features for medical devices with external data interfaces, by capability security level, building on the IEC 62443 foundational requirements. It is the bridge between industrial control security and the medical device world.
Recent changes
No changes recorded yet — we are watching, and nothing has been published.
Key dates
No upcoming datesVersion history
-
IEC TR 60601-4-5:2021 Major versionCurrent
Edition 1.0: technical specifications for security features of medical devices used in medical IT networks, by capability security level, based on IEC TS 62443-1-1:2009. source
Who it applies to
Guidance on the security capabilities of medical devices with external data interfaces, which the medical community can use to integrate devices into medical IT networks.
- What it provides
- Detailed technical specifications for security features of medical devices used in medical IT networks, with specifications for different medical device capability security levels (SL-C). source
- Basis
- It is based on the seven foundational requirements described in IEC TS 62443-1-1:2009. source
- Devices covered
- Medical electrical equipment, medical electrical systems and medical device software with external data interfaces, for example when connected to a medical IT network or when a human interface is used to process confidential data. source
- Exclusions
- It does not apply to in-vitro diagnostic devices, or to other software on a medical IT network that is not medical device software. source
- Network integration
- The specified capabilities help the medical community integrate a device into security zones and conduits of a medical IT network with an appropriate target security level (SL-T). source
- Review date
- The IEC webstore gives a stability date of 2028 for this edition. source
How compliance is assessed
A Technical Report of guidance and interpretation; a device's security capability level (SL-C) is matched to the target security level (SL-T) of the network it joins.
- Document type
- Published as a Technical Report in the IEC 60601 series under "Guidance and interpretation". source
- Capability levels
- The report specifies security capabilities by medical device capability security level (SL-C), which members of the medical community can use to integrate the device into a medical IT network with an appropriate target security level (SL-T). source
Enforcement and penalties
A paid IEC Technical Report, sold through the IEC webstore.
- Purchase
- The report is sold through the IEC webstore (51 pages, edition 1.0). source
Documents
Verified against official sources on 18 October 2026. We monitor the official sources for this framework. Watching since 20 September 2026. Subscribe to IEC TR 60601-4-5 (RSS)