类别: STANDARDS

医疗器械网络安全

保护联网医疗器械免受未授权访问、数据泄露和恶意攻击的实践。FDA根据2023年PATCH法案要求在上市前提交中包含网络安全文件。

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

Medical device cybersecurity covers design, labeling, and postmarket management of threats to device safety/effectiveness—especially for connected and software devices.

PROCESS / STEPS

Threat model during design; apply secure development practices.
Document SBOM and updateability where expected.
Plan coordinated vulnerability disclosure and patches as FSCA when needed.
Monitor field signals for exploit patterns.

EXAMPLES

Connected infusion pumps and imaging systems are frequent cybersecurity focus areas.

RELATED GUIDES & TOOLS

SOURCES

FDA Cybersecurity ↗

Track regulatory signals related to 医疗器械网络安全 across 27 authorities in real time.

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