| Preface | 5 |
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| Contents | 9 |
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| Formalism in Safety Cases | 12 |
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| 1 Introduction | 12 |
| 2 The Top-Level Argument | 14 |
| 3 Lower-Level Arguments | 19 |
| 4 Probabilistic Arguments | 21 |
| 5 Summary, and Suggestions for Future Work | 23 |
| Bureaucracy, Safety and Software: a Potentially Lethal Cocktail | 28 |
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| 1 Overview | 28 |
| 2 Safety Standards and Software Development | 36 |
| 3 Conclusions – What is to be done? | 41 |
| Cost-Efficient Methods and Processes for Safety Relevant Embedded Systems ( CESAR) – An Objective Overview | 44 |
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| 1 Introduction | 44 |
| 2 Concept and Objectives | 45 |
| 3 Creating the RTP | 47 |
| 4 Safety-Diagnosability Task Force | 49 |
| 5 CESAR Challenges | 55 |
| 6 Conclusion | 56 |
| Safety and Assurance Cases: Past, Present and Possible Future – an Adelard Perspective | 58 |
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| 1 History of Computer System Safety and Related Standards | 58 |
| 2 Current Practice in Software Safety and Regulation | 61 |
| 3 Uptake and Development of the Safety Case Approach | 63 |
| 4 Current Practice in Safety Cases | 64 |
| 4.1 Safety Case Structures | 65 |
| 4.2 Confidence, Challenge and Meta-Cases | 67 |
| 4.3 Other Research | 68 |
| 4.4 Specific Tool Support | 69 |
| 5 Future Directions | 70 |
| 5.1 Safety Case Methodology Enhancement | 70 |
| 5.2 Extension to Other Areas | 70 |
| 5.3 Safety Case Structuring | 71 |
| 5.4 Confidence and Challenge | 71 |
| 6 Concluding Remarks | 71 |
| An Integrated Project Management Life Cycle Supporting System Safety | 76 |
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| 1 Introduction | 76 |
| 2 Integrated Project Management Life Cycle | 84 |
| 3 Conclusion | 87 |
| Patterns in Safety-Related Projects | 89 |
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| 1 Background | 89 |
| 2 The Project Patterns | 92 |
| 3 The Decision Tool | 101 |
| 4 Current Status | 101 |
| 5 Conclusions and Further Work | 103 |
| Applying IEC 61508 to Air Traffic Management Systems | 106 |
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| 1 Introduction | 106 |
| 2 The IEC 61508 Model of the World | 107 |
| 3 Air Traffic as the EUC | 108 |
| 4 Deriving Safety Requirements for ATM Systems | 110 |
| 5 Unusual Aspects of ATC | 113 |
| 6 Increased Need for Automation | 114 |
| 7 Applying Parts 2 and 3 of IEC 61508 | 115 |
| 8 Conclusions | 115 |
| Phileas, a Safety Critical Trip around the World | 117 |
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| 1 Introduction | 117 |
| 2 Guidance System Overview | 118 |
| 2.1 Navigation | 118 |
| 2.2 Control | 119 |
| 3 Safety Engineering | 119 |
| 4 Development Process | 121 |
| 4.1 System Definition | 122 |
| 4.2 System Design | 122 |
| 4.3 System Qualification | 124 |
| 5 Safety Concept | 124 |
| 6 Certification Process | 126 |
| 6.1 Safety Case | 126 |
| 6.2 Homologation | 127 |
| 7 Conclusions | 128 |
| An Overview of the SoBP for Software in the Context of DS 00- 56 Issue 4 | 130 |
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| 1 Introduction | 130 |
| 2 Structure of the SoBP | 131 |
| 2.1 Requirements of DS 00-56: Safety Cases | 132 |
| 3 Managerial Issues | 133 |
| 3.1 Software Safety Management Phases | 134 |
| 3.2 Swim-lane Diagram | 134 |
| 3.3 Managerial Summary | 142 |
| 4 Technical Issues | 142 |
| 4.1 Pattern Catalogue | 143 |
| 4.2 Assurance-based Argument Development Method | 144 |
| 5 Conclusions | 147 |
| IEC80001 and Future Ramifications for Health Systems not currently classed as Medical Devices | 149 |
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| 1 Introduction | 150 |