ISO 13485vsNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
See exactly how ISO 13485 controls map to NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485 maps to NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security with 25% coverage across 10 directly mapped controls. Analysis of 44 ISO 13485 controls identifies 34 compliance gaps — primarily concentrated in Product Realisation.
Source: TheArtOfService Knowledge Graph | 44 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 12 of 12 mapped controls across 5 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
Resource Management(2 mappings)
ISO 13485: Patient Data Protection(3 mappings)
ISO 13485: Administrative Safeguards(3 mappings)
ISO 13485: Technical Safeguards(3 mappings)
ISO 13485: Physical Safeguards(1 mappings)
Related Comparisons
Other ISO 13485 comparisons
Other NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security comparisons
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What are the key differences between ISO 13485 and NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security?
ISO 13485 has 44 controls across its framework, while NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security covers 8 controls. Direct mapping analysis identifies 10 overlapping controls (25% coverage). The frameworks diverge most significantly in Product Realisation, where 7 ISO 13485 controls have no direct NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security equivalent.
How many controls map between ISO 13485 and NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security?
Of 44 total ISO 13485 controls, 10 map directly to NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security controls — representing 25% coverage. The remaining 34 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485 to NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security?
34 ISO 13485 controls have no direct equivalent in NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security. The highest concentration of gaps is in Product Realisation with 7 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 ISO 13485 and NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security?
The domain with the highest gap count is Product Realisation (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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