网络安全评估
- AAMI TIR 57: 2016/(R(2023)
- NIST SP 800-30:2012
- IEC 81001-5-1:2021
- ANSI/ISA 62443-4-1 section 9.4
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices
- Content of Premarket Submissions for Device Software Functions SA 62443-4-1 section 9.4
依据监管法规/标准