IEC TR 80002-1:2009

FOREWORD
INTRODUCTION
1 General
  1.1 Scope
  1.2 Normative references
2 Terms and definitions
3 General requirements for RISK MANAGEMENT
  3.1 RISK MANAGEMENT PROCESS
  3.2 Management responsibilities
  3.3 Qualification of personnel
  3.4 RISK MANAGEMENT plan
  3.5 RISK MANAGEMENT FILE
4 RISK ANALYSIS
  4.1 RISK ANALYSIS PROCESS
  4.2 INTENDED USE and identification of characteristics
      related to the SAFETY of the MEDICAL DEVICE
  4.3 Identification of HAZARDS
  4.4 Estimation of the RISK(S) for each HAZARDOUS
      SITUATION
5 RISK EVALUATION
6 RISK CONTROL
  6.1 RISK reduction
  6.2 RISK CONTROL option analysis
  6.3 Implementation of RISK CONTROL measure(s)
  6.4 RESIDUAL RISK EVALUATION
  6.5 RISK/benefit analysis
  6.6 RISKS arising from RISK CONTROL measures
  6.7 Completeness of RISK CONTROL
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and POST-PRODUCTION information
Annex A (informative) - Discussion of definitions
Annex B (informative) - Examples of software causes
Annex C (informative) - Potential software-related pitfalls
Annex D (informative) - Life-cycle/risk management grid
Annex E (informative) - SAFETY cases
Bibliography
Index
Index of defined terms

IEC/TR 80002-1:2009(E) provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to medical device software with reference to IEC 62304:2006, Medical device software - Software life cycle processes. It does not add to, or otherwise change, the requirements of ISO 14971:2007 or IEC 62304:2006. IEC/TR 80002-1:2009(E) is aimed at risk management practitioners who need to perform risk management when software is included in the medical device/system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. ISO 14971, recognized worldwide by regulators, is widely acknowledged as the principal standard to use when performing medical device risk management. IEC 62304:2006, makes a normative reference to ISO 14971 requiring its use. The content of these two standards provides the foundation for this technical report. It should be noted that even though ISO 14971 and this technical report focus on medical devices, this technical report may be used to implement a safety risk management process for all software in the healthcare environment independent of whether it is classified as a medical device. IEC/TR 80002-1:2009 is not intended to be used as the basis of regulatory inspection or certification assessment activities.