AAMI TIR80002 1 2009
$140.32
AAMI/IEC TIR80002-1:2009 – Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 80 |
Provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software. It does this in the context of ISO 14971:2007, Medical devices – Application of risk management to medical devices and in the context of ISO/IEC 62304:2006, Medical device software – Software life cycle processes.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC TIR80002-1:2009, Medical device software – Part 1:Guidance on the application of ISO14971 to medical device software |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 8 | Glossary of equivalent standards |
| 10 | Committee representation |
| 12 | Background on AAMI adoption of IEC/TR 80002-1:2009 |
| 13 | FOREWORD |
| 15 | INTRODUCTION |
| 17 | 1 General 1.1 Scope |
| 18 | 1.2 Normative references 2 Terms and definitions |
| 19 | 3 General requirements for risk management 3.1 Risk management process 3.1.1 General |
| 21 | 3.1.2 Iteration |
| 22 | 3.1.3 Pro-active or reactive design approach to safety 3.1.4 Characteristics of safe systems incorporating software |
| 23 | 3.2 Management responsibilities |
| 24 | 3.3 Qualification of personnel 3.3.1 General |
| 25 | 3.3.2 Intended use/domain knowledge 3.3.3 Programming experience and attitude |
| 26 | 3.4 Risk management plan 3.4.1 General |
| 27 | 3.4.2 Relationship between risk management plan and software development plan |
| 28 | 3.4.3 Specific risk-related topics of the software development plan according to IEC 62304 3.5 Risk management file |
| 30 | 4 Risk analysis 4.1 Risk analysis process |
| 31 | 4.2 Intended use and identification of characteristics related to the safety of the medical device 4.2.1 General |
| 32 | 4.2.2 User interface 4.2.3 Medical device interconnection |
| 33 | 4.3 Identification of hazards |
| 35 | 4.4 Estimation of the risk(s) for each hazardous situation 4.4.1 General |
| 36 | 4.4.2 Methods of identification 4.4.3 Probability |
| 38 | 4.4.4 Severity 5 Risk evaluation |
| 39 | 6 Risk control 6.1 Risk reduction 6.2 Risk control option analysis |
| 40 | 6.2.1 Choosing risk control options for complex systems 6.2.1.1 General 6.2.1.2 Inherent safety by design 6.2.1.3 Protective measures |
| 41 | 6.2.1.4 Information for safety 6.2.1.5 Which events need risk control measures? |
| 43 | 6.2.2 Risk control methods 6.2.2.1 Overview 6.2.2.2 Risk control measures and software architectural design 6.2.2.2.1 Overview 6.2.2.2.2 Inherently safe design by architecture features |
| 44 | 6.2.2.2.3 Fault tolerant architectures |
| 45 | 6.2.2.2.4 Segregation to reduce risk from software causes |
| 46 | 6.2.2.3 Details on protective measures 6.2.2.4 Preventing and announcing hazardous situations promptly |
| 47 | 6.2.2.5 Risk control measures for software anomalies 6.2.2.6 Process as a risk control measure |
| 48 | 6.2.3 Software of unknown provenance (soup) considerations |
| 49 | 6.3 Implementation of risk control measure(s) |
| 50 | 6.4 Residual risk evaluation 6.5 Risk/benefit analysis |
| 51 | 6.6 Risks arising from risk control measures 6.7 Completeness of risk control |
| 52 | 7 Evaluation of overall residual risk acceptability |
| 53 | 8 Risk management report |
| 54 | 9 Production and post-production information |
| 56 | Annex A Discussion of definitions |
| 58 | Annex B Examples of software causes |
| 68 | Annex C Potential software-related pitfalls |
| 73 | Annex D Life-cycle/risk management grid |
| 76 | Annex E SAFETY cases |
| 77 | Bibliography |
| 78 | Index |
| 79 | Index of defined terms |
