Framework overlap

Does Australia NHMRC National Statement on Ethical Conduct in Human Research cover IEC 60601-1?

You hold Australia NHMRC National Statement on Ethical Conduct in Human Research and have been told to do IEC 60601-1. Here is how much overlaps, control by control.

14% of IEC 60601-1 you already have

Australia NHMRC National Statement on Ethical Conduct in Human Research already covers about 14% of IEC 60601-1, leaving 32 of 37 controls as genuinely new work.

Already covered 0 Likely covered 5 New work 32

No control in Australia NHMRC National Statement on Ethical Conduct in Human Research 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 Australia NHMRC National Statement on Ethical Conduct in Human Research 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
60601-1.13
Hazardous situations and fault conditions
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
60601-1.7.1
Equipment identification and marking
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 5 you already have
60601-1.12
Accuracy of controls and instruments
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

How this is calculated

Already covered means a mapping runs from a control in Australia NHMRC National Statement on Ethical Conduct in Human Research 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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