Maps to
IEC 81001-5-1: §5.6
Requirement text
The manufacturer can perform some of the software system testing as a part of software integration testing (see 5.7). As a part of health software integration testing, the manufacturer should consider security policy differences across trust boundaries.
What changed
IEC 81001-5-1:2021 is the first standalone cybersecurity standard purpose-built for health software and medical device software. Published in December 2021, it was adapted from IEC 62443-4-1 (industrial control systems security) to address the unique safety and regulatory context of medical devices — adding 64 health-specific requirements that account for patient safety, clinical workflows, and the manufacturer-HDO relationship.
The standard mirrors IEC 62304's lifecycle structure but adds security-specific activities at every phase — planning, development, testing, release, and maintenance. It requires security risk management to be integrated with ISO 14971 safety risk management, not treated as a separate IT concern. FDA formally recognized it as Consensus Standard #13-112 in December 2022 and references it as providing a framework for the Secure Product Development Framework (SPDF) required by Section 524B.
EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028. Despite this delay, Notified Bodies and Competent Authorities universally recognize it as "state of the art" for health software cybersecurity under MDR GSPR Annex I, Section 17.2. Missing or inadequate cybersecurity documentation is already a top cause of Notified Body major non-conformities for SaMD. A December 2025 Interpretation Sheet (ISH1:2025) clarified software item classification into maintained, supported, and required software categories, affecting risk transfer and post-market obligations.
Atomic constraints
- •Integration testing should consider security policy differences across trust boundaries.
Common gaps
Integration testing does not include security test cases
moderateIntegration testing verifies functional component interactions but does not test security-relevant interactions — authentication enforcement between components, data encryption in transit, or privilege escalation through component interactions.
Evidence signals
- •
FILE_EXISTS
Integration.*Test|Integration.*Plan|Test.*Plan
- •
CONTENT_MATCH
Does this document describe integration testing that considers security policy differences across trust boundaries between software components?
Audit defense
The Integration Test Plan for [your product] (Doc ID: [your document ID]) documents consideration of security policy differences across trust boundaries as part of integration testing, consistent with clause 5.6.