IEC 60601-1 - Medical Electrical Equipment Safety
Clause 6-7: Classification, Identification and Marking

IEC 60601-1 - Medical Electrical Equipment Safety 60601-1.7.1: Equipment identification and marking

Labeling durability, legibility, measurement units, symbols, and required marking on ME equipment

What else in your programme already covers this

This control maps to 64 controls across 51 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • CFR211-G-122 Section 211.122 - Materials Examination and Usage Criteria
  • CFR211-G-125 Section 211.125 - Labeling Issuance
  • CFR211-G-130 Section 211.130 - Packaging and Labeling Operations

API 1164 · 1 control

BSI IT-Grundschutz · 1 control

  • BSI-15 Security categorization
  • QMSR-820.45 Device labelling and packaging controls (§820.45)

FISMA · 1 control

IEC 62443 · 1 control

IEEE 1686 · 1 control

IEEE 7000 · 1 control

ISMAP (Japan) · 1 control

ISO 27017 · 1 control

ISO 27018 · 1 control

ISO 27019 · 1 control

ISO 27043 · 1 control

ISO/IEC 27010:2015 · 1 control

ISO/SAE 21434 · 1 control

Japan AI Guidelines · 1 control

MITRE ATT&CK · 1 control

MITRE D3FEND · 1 control

MTCS (Singapore) · 1 control

  • NAIC-2 Information Security Program (ISP) - Section 4

NIST SP 1800-32 · 1 control

  • NISTSP115-8 Operational Considerations - Tools, Reporting Templates, ISMS Integration, Annex Material

NIST SP 800-123 · 1 control

NIST SP 800-137 · 1 control

  • NISTSP137-1 ISCM Strategy, Governance, and Volatility Assessment

NIST SP 800-144 · 1 control

  • NISTSP144-5 Identity and Access in Cloud, Federation, and Privileged Access

NIST SP 800-145 · 1 control

  • NISTSP145-8 Governance, Reporting, and Stakeholder Education on Cloud Definition

NIST SP 800-146 · 1 control

NIST SP 800-190 · 1 control

NIST SP 800-61 · 1 control

  • NISTSP61-4 Detection and Analysis: Sources, Triage, Categorisation, Prioritisation

NIST SP 800-63-4 · 1 control

  • NISTSP63R4-7 Privacy, Records Retention, and User-Controlled Wallets

NIST SP 800-88 · 1 control

  • NISTSP88-1 Media Sanitization Policy, Roles, and Decision Framework

NIST SP 800-92 · 1 control

  • NISTSP92-7 Privacy in Logs, Sensitive Content Handling, Cloud and SaaS Log Considerations
  • QRCM-1.3 Data Classification for Migration

OECD AI Principles · 1 control

  • OECDAI-3 Robustness, Security, Safety, and Adversarial Attack Protection

OWASP ASVS · 1 control

OWASP MASVS · 1 control

OWASP SAMM · 1 control

  • OWASPSAMM-2 Design: Threat Assessment, Security Requirements, Security Architecture
  • OMANCS-4 Data Protection, Cryptography, and Privacy Alignment

OpenSSF Scorecard · 1 control

  • OSSFSC-2 Dependency Management, Pinning, Updates, Vulnerability Tracking
  • PASONE-1 Security Triage Process, Asset Sensitivity Classification, and Threat Assessment

PTES · 1 control

  • PSPF24-2 Information Security, Cybersecurity Maturity, Essential Eight

SASB Standards · 1 control

SLSA · 1 control

  • SUPCHAIN-1 Build Integrity - Source, Build, Provenance
  • UKAI-1 Risk-Based Approach and Pro-Innovation Principles

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Clause 6-7: Classification, Identification and Marking

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