IEC 60601-1 - Medical Electrical Equipment SafetyvsOwn Risk and Solvency Assessment (ORSA) - NAIC Model Act
See exactly how IEC 60601-1 - Medical Electrical Equipment Safety controls map to Own Risk and Solvency Assessment (ORSA) - NAIC Model Act. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
IEC 60601-1 - Medical Electrical Equipment Safety maps to Own Risk and Solvency Assessment (ORSA) - NAIC Model Act with 8% coverage across 3 directly mapped controls. Analysis of 38 IEC 60601-1 - Medical Electrical Equipment Safety controls identifies 38 compliance gaps — primarily concentrated in Clause 11-14: Temperatures, Accuracy, Faults, and PEMS.
Source: TheArtOfService Knowledge Graph | 38 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Clause 4-5: General Requirements and Testing(3 mappings)
Related Comparisons
Other IEC 60601-1 - Medical Electrical Equipment Safety comparisons
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What are the key differences between IEC 60601-1 - Medical Electrical Equipment Safety and Own Risk and Solvency Assessment (ORSA) - NAIC Model Act?
IEC 60601-1 - Medical Electrical Equipment Safety has 38 controls across its framework, while Own Risk and Solvency Assessment (ORSA) - NAIC Model Act covers 4 controls. Direct mapping analysis identifies 3 overlapping controls (8% coverage). The frameworks diverge most significantly in Clause 11-14: Temperatures, Accuracy, Faults, and PEMS, where 4 IEC 60601-1 - Medical Electrical Equipment Safety controls have no direct Own Risk and Solvency Assessment (ORSA) - NAIC Model Act equivalent.
How many controls map between IEC 60601-1 - Medical Electrical Equipment Safety and Own Risk and Solvency Assessment (ORSA) - NAIC Model Act?
Of 38 total IEC 60601-1 - Medical Electrical Equipment Safety controls, 3 map directly to Own Risk and Solvency Assessment (ORSA) - NAIC Model Act controls — representing 8% coverage. The remaining 38 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping IEC 60601-1 - Medical Electrical Equipment Safety to Own Risk and Solvency Assessment (ORSA) - NAIC Model Act?
38 IEC 60601-1 - Medical Electrical Equipment Safety controls have no direct equivalent in Own Risk and Solvency Assessment (ORSA) - NAIC Model Act. The highest concentration of gaps is in Clause 11-14: Temperatures, Accuracy, Faults, and PEMS with 4 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between IEC 60601-1 - Medical Electrical Equipment Safety and Own Risk and Solvency Assessment (ORSA) - NAIC Model Act?
The domain with the highest gap count is Clause 11-14: Temperatures, Accuracy, Faults, and PEMS (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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