TheArtOfService
Cross-Framework Mapping

ISO 13485vsNIST SP 800-66

See exactly how ISO 13485 controls map to NIST SP 800-66. Pre-computed mappings, identified gaps, and coverage analysis.

19
Controls Mapped
10
Gaps Found
45%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 13485 maps to NIST SP 800-66 with 45% coverage across 13 directly mapped controls. Analysis of 29 ISO 13485 controls identifies 16 compliance gaps — primarily concentrated in ISO 13485: Organizational Requirements.

Source: TheArtOfService Knowledge Graph | 29 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 19 of 19 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Resource Management(1 mappings)

6.4Logging and Monitoring
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication

ISO 13485: Patient Data Protection(7 mappings)

ISO13485-01ePHI access controls and authorization3 targets
→NISTSP66-2Workforce Security, Information Access Management, and Awareness Training
→NISTSP66-5Physical Safeguards: Facility Access, Workstation Use and Security, Device and Media Controls
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication
ISO13485-02ePHI encryption at rest and in transit
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication
ISO13485-03Minimum necessary standard enforcement
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication
ISO13485-04Patient data de-identification procedures
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication
ISO13485-05Audit trail for ePHI access
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication

ISO 13485: Administrative Safeguards(6 mappings)

ISO13485-06Security management process and risk analysis
→NISTSP66-1Security Management Process: Risk Analysis and Risk Management for ePHI
ISO13485-07Workforce security and clearance procedures
→NISTSP66-2Workforce Security, Information Access Management, and Awareness Training
ISO13485-08Information access management3 targets
→NISTSP66-2Workforce Security, Information Access Management, and Awareness Training
→NISTSP66-5Physical Safeguards: Facility Access, Workstation Use and Security, Device and Media Controls
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication
ISO13485-09Security awareness and training program
→NISTSP66-2Workforce Security, Information Access Management, and Awareness Training

ISO 13485: Technical Safeguards(2 mappings)

ISO13485-12Unique user identification and authentication
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication
ISO13485-16Transmission security and encryption
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication

ISO 13485: Physical Safeguards(3 mappings)

ISO13485-17Facility access controls3 targets
→NISTSP66-2Workforce Security, Information Access Management, and Awareness Training
→NISTSP66-5Physical Safeguards: Facility Access, Workstation Use and Security, Device and Media Controls
→NISTSP66-6Technical Safeguards: Access Control, Audit Controls, Integrity, Person Authentication

Related Comparisons

Other ISO 13485 comparisons

ISO 13485 vs MDS2 (Medical Device)13 mappingsISO 13485 vs MARS-E13 mappingsISO 13485 vs ISO 2779913 mappingsISO 13485 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements12 mappingsISO 13485 vs NIST Privacy Framework12 mappingsISO 13485 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)12 mappingsISO 13485 vs Oman National Cybersecurity Framework11 mappingsISO 13485 vs FTC GLBA Safeguards Rule (16 CFR Part 314)11 mappings

Other NIST SP 800-66 comparisons

Turkey KVKK vs NIST SP 800-664 mappingsPrivacy Act 1988 (Australia) vs NIST SP 800-664 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs NIST SP 800-664 mappingsISO 27799 vs NIST SP 800-664 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs NIST SP 800-664 mappingsBSI IT-Grundschutz vs NIST SP 800-664 mappingsAnnex 11 to EU GMP - Computerised Systems vs NIST SP 800-664 mappingsISO 27019 vs NIST SP 800-664 mappings

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What are the key differences between ISO 13485 and NIST SP 800-66?

ISO 13485 has 29 controls across its framework, while NIST SP 800-66 covers 8 controls. Direct mapping analysis identifies 13 overlapping controls (45% coverage). The frameworks diverge most significantly in ISO 13485: Organizational Requirements, where 4 ISO 13485 controls have no direct NIST SP 800-66 equivalent.

How many controls map between ISO 13485 and NIST SP 800-66?

Of 29 total ISO 13485 controls, 13 map directly to NIST SP 800-66 controls — representing 45% coverage. The remaining 16 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 800-66?

16 ISO 13485 controls have no direct equivalent in NIST SP 800-66. The highest concentration of gaps is in ISO 13485: Organizational Requirements 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 ISO 13485 and NIST SP 800-66?

The domain with the highest gap count is ISO 13485: Organizational Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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