FOREWORD

INTRODUCTION

1General

1.1Scope

1.2Normative references

2Terms and definitions

3General requirements for risk management

3.1Risk management process

3.1.1General

3.1.2Iteration

3.1.3Pro-active or reactive design approach to safety

3.1.4Characteristics of safe systems incorporating software

3.2Management responsibilities

3.3Qualification of personnel

3.3.1General

3.3.2Intended use/domain knowledge

3.3.3Programming experience and attitude

3.4Risk management plan

3.4.1General

3.4.2Relationship between risk management plan and software development plan

3.4.3Specific risk-related topics of the software development plan according to

3.5Risk management file

4Risk analysis

4.1Risk analysis process

4.2Intended use and identification of characteristics related to the safety of the medical device

4.2.1General

4.2.2User interface

4.2.3Medical device interconnection

4.3Identification of hazards

4.4Estimation of the risk(s) for each hazardous situation

4.4.1General

4.4.2Methods of identification

4.4.3Probability

4.4.4Severity

5Risk evaluation

6Risk control

6.1Risk reduction

6.2Risk control option analysis

6.2.1Choosing risk control options for complex systems

6.2.1.1General

6.2.1.2Inherent safety by design

6.2.1.3Protective measures

6.2.1.4Information for safety

6.2.1.5Which events need risk control measures?

6.2.2Risk control methods

6.2.2.1Overview

6.2.2.2Risk control measures and software architectural design

6.2.2.2.1Overview

6.2.2.2.2Inherently safe design by architecture features

6.2.2.2.3Fault tolerant architectures

6.2.2.2.4Segregation to reduce risk from software causes

6.2.2.3Details on protective measures

6.2.2.4Preventing and announcing hazardous situations promptly

6.2.2.5Risk control measures for software anomalies

6.2.2.6Process as a risk control measure

6.2.3Software of unknown provenance (soup) considerations

6.3Implementation of risk control measure(s)

6.4Residual risk evaluation

6.5Risk/benefit analysis

6.6Risks arising from risk control measures

6.7Completeness of risk control

7Evaluation of overall residual risk acceptability

8Risk management report

9Production and post-production information

Annex ADiscussion of definitions (informative)

Annex BExamples of software causes (informative)

Annex CPotential software-related pitfalls (informative)

Annex DLife-cycle/risk management grid (informative)

Annex ESafety cases (informative)

Bibliography