IEC 62304 §5.7 system testing and ISO 13485 validation activities covering functional requirement verification against specifications.
Four security test types required: functional security verification, performance and scalability, boundary and malformed input, and cloud/SaaS service testing within shared responsibility boundaries.
Security test plan with requirement-to-test-case traceability covering all four categories — bulk automated scanning without per-requirement test cases is a major submission gap.
Maps to
IEC 81001-5-1: §5.7.1 SECURITY requirements testing
Requirement text
The manufacturer shall establish an activity (or activities) for verifying that the health software security functions meet the security requirements and that the health software handles error scenarios and invalid input. Based on the intended environment of use, types of testing shall include: a) functional testing of security requirements; b) performance and scalability testing; c) boundary/edge condition, stress and malformed or unexpected input tests with potential security consequences; and d) testing each software service used by health software (cloud, SaaS, IaaS, PaaS) in the context of responsibility agreements among service providers, manufacturers and operators.
Why this clause exists
Security requirements testing — verification that each security requirement is demonstrably satisfied by the implemented system — is the formal closure of the traceability chain from threat through requirement through implementation to verification. Without requirements-based testing, the manufacturer cannot claim that the implemented security controls actually address the threats identified in the threat model: the requirements may have been written, the design may reference them, the implementation may have been reviewed, but there is no test result confirming that the device behaves as specified under the relevant conditions. IEC 81001-5-1:2021 clause 5.7.1 requires that each security requirement in the Security Requirements Specification have at least one test case that verifies its implementation, with a documented pass/fail result. This is not a penetration testing activity — it is functional verification of specified requirements. FDA's premarket cybersecurity guidance expects a test plan and test report covering each security requirement, with results available for submission review. The traceability from requirement to test to result is inspectable and must be complete.
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 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 recognized it as Consensus Standard 13-122 (date of entry December 19, 2022). FDA's February 2026 cybersecurity guidance, Section V, lists IEC 81001-5-1 among the "possible frameworks to consider" for secure product development, and FDA's recognition record for the standard notes that conformance "may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act".
EU MDR harmonization was originally targeted for May 2024 but postponed to May 2028.
Common gaps (what we see in audits)
- Security requirements not individually verified — While functional requirements have individual test cases, security requirements frequently lack individual test cases. Security testing is treated as a bulk activity (run a scanner) rather than requirement-by-requirement verification with traceability.