YY/T 1406.1-2016 in English
VALIDMedical device software—Part 1:Guidance on the application of ISO 14971 to medical device software
- Issued on:2016-03-23
- Implemented on:2017-01-01
- File Format:PDF
- Delivery:Via email within 5 business days
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本标准适用于医疗器械软件的风险分析、评价和控制。
本标准规定了YY/T 0316《医疗器械风险管理对医疗器械的应用》标准应用于医疗器械软件的指南，提出了控制和降低医疗器械软件风险的方法。
Introduction
Key Points of Medical Device Software Risk Management
This guide is based on YY/T 1406.1-2016 (equivalent to IEC/TR 80002-1:2009), and provides a professional technical framework for the implementation of ISO 14971 risk management for medical device software.
Scope of application of the standard
- Applicable to software systems that are components of medical devices or independent medical devices
- Covering risk control requirements for the entire software life cycle
- Not applicable to production quality management system software and development tools
Comparison of key risk management processes
| Phase | Hardware Risk Management | Software-specific requirements |
|---|---|---|
| Risk Analysis | Probability estimation is feasible | Focus on severity analysis (probability is usually set to 1) |
| Risk Control | Mainly hardware protection measures | Architecture isolation, defensive programming, diversity design |
| Verification method | Functional testing is the main method | Static analysis + dynamic testing + formal verification |
Key technologies for software security design
Typical risk control measures
- Architecture isolation: physical/logical isolation of security-related and non-security software items
- Redundant design: use of diverse programming (independent implementation by different teams)
- Real-time monitoring: runtime protection such as memory verification and watchdog timer
SOUP component management
For software from unknown sources, it is necessary to establish: version control mechanism, security patch evaluation process, and failure mode analysis document
Implementation suggestions
- Establish an interdisciplinary team (clinical + software + system engineers) to identify hazards
- Use a combined analysis method of FTA and FMEA
- Maintain a traceability matrix: requirements → design → test cases → risk control measures
- Post-production monitoring should include software anomaly statistics and trend analysis
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