Comparison guide
ISO 14971 vs AAMI SW96
They are not competing standards. SW96 is the cybersecurity overlay on ISO 14971's safety risk-management framework.
Side-by-side breakdown
| Dimension | ISO 14971 | ANSI/AAMI SW96 |
|---|---|---|
| Scope | Safety risk management for medical devices. | Cybersecurity risk management for medical devices. |
| Current edition | ISO 14971:2019; distinguish the European EN adoption and its amendment. | ANSI/AAMI SW96:2023. |
| Status | Medical device safety risk-management framework; assess applicable regulatory use. | FDA-recognized consensus standard for cybersecurity risk. |
| Risk inputs | Hazards, hazardous situations, harm. | Threats, vulnerabilities, exploitability, patient impact. |
| Risk file | One safety risk file (RMF). | Parallel security risk file linked to the safety RMF. |
| Acceptability | Risk acceptability defined by manufacturer's policy. | Manufacturer-defined acceptance criteria; assess exploitability and security impact, with separate patient-harm analysis where applicable. |
| Used together | Connect relevant cybersecurity findings to safety risk records when a credible patient-harm pathway exists. | Designed as an overlay; SW96 explicitly references 14971. |
When to use which
Document connections between cybersecurity findings and safety risk records where a credible patient-harm pathway exists. The manufacturer supplies harm severity and owns acceptance criteria and risk decisions.
Preserve relevant TIR57 history and assess gaps against the standards and guidance used in your current process. A crosswalk records evidence connections; it does not establish automatic equivalence or acceptance.
Frequently asked questions
Keep exploring
Ready when you are
Secure your device before it reaches patients.
30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.