Framework overlap

Does GDPR cover IEC 60601-1?

You hold GDPR and have been told to do IEC 60601-1. Here is how much overlaps, control by control.

19% of IEC 60601-1 you already have

GDPR already covers about 19% of IEC 60601-1, leaving 30 of 37 controls as genuinely new work.

Already covered 0 Likely covered 7 New work 30

No control in GDPR maps directly to one in IEC 60601-1. Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

Nothing in GDPR reaches these. This is the list to scope.

60601-1-10
Protective Earth Connection
60601-1-11
Home Healthcare Environment
60601-1-12
Emergency Medical Services Environment
60601-1-13
Software Lifecycle (IEC 62304)
60601-1-14
Programmable Electrical Medical System (PEMS)
60601-1-15
Construction and Components
60601-1-16
Marking, Labelling and Documents
60601-1-2
Electromagnetic Compatibility
60601-1-4.2
Risk Management Process
60601-1-4.3
Essential Performance
60601-1-4.5
Equivalent Safety
60601-1-6
Usability Engineering
60601-1-7
Mechanical Hazards
60601-1-8
Alarm Systems
60601-1-9
Leakage Current Testing
60601-1-CYB
Cybersecurity for Networked Equipment
60601-1-PMS
Post-Market Surveillance Feedback
60601-1-PROD
Production and Routine Testing
60601-1.1
Scope, object, and related standards
60601-1.10
Protection against radiation hazards
60601-1.11
Protection against excessive temperatures and other hazards
60601-1.14
Programmable electrical medical systems (PEMS)
60601-1.15
Construction of ME equipment
60601-1.16
ME systems
60601-1.17
Electromagnetic compatibility (EMC)
60601-1.5.2
Test conditions and environment
60601-1.6
Classification of ME equipment and systems
60601-1.7.2
Documents and instructions for use
60601-1.8
Protection against electrical hazards
60601-1.9
Protection against mechanical hazards
Show the 7 you already have
60601-1.12
Accuracy of controls and instruments
60601-1.13
Hazardous situations and fault conditions
60601-1.3
Terminology and definitions
60601-1.4.1
General requirements
60601-1.4.2
Risk management process
60601-1.5.1
General requirements for testing
60601-1.7.1
Equipment identification and marking

How this is calculated

Already covered means a mapping runs from a control in GDPR to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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