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PD ISO/TS 81001-2-1:2025 Health software and health IT systems safety, effectiveness and security - Coordination. Guidance and requirements for the use of assurance cases for safety and security >
PD ISO/TS 81001-2-1:2025 Health software and health IT systems safety, effectiveness and security - Coordination. Guidance and requirements for the use of assurance cases for safety and security, 2025
- undefined
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Assurance case [Go to Page]
- 5 General requirements and recommendations [Go to Page]
- 6 Developing an assurance case using GSN [Go to Page]
- 7 Assurance case change management
- 8 Security assurance case
- Annex A (informative) Generic risk-based HIT assurance case pattern
- Annex B (informative) IEC 80001-1 Compliance assurance case pattern
- Annex C (informative) AI assurance case pattern
- Annex D (informative) Security assurance case pattern
- Annex E (informative) Assurance notation cross reference
- Annex F (informative) Summary of assurance case requirements relative to organizations
- Bibliography [Go to Page]
