AAMI HE74 : 2001 : R2009

Committee representation
Foreword
Introduction
1 Scope
    1.1 The benefits of HFE
    1.2 Avoiding design-induced error
    1.3 Improving usability
2 Normative references
3 Definitions
4 Overview of the HFE process
    4.1 Iterative nature of the HFE cycle
    4.2 User research
    4.3 Design concept development (conceptual design)
    4.4 Design criteria and requirements development
    4.5 Detailed design and specification
    4.6 Design evaluation
    4.7 Design implementation and deployment
5 Planning the HFE process
    5.1 Assuring adequate HFE involvement in the design team
    5.2 Scaling the HFE effort
    5.3 Documenting the HFE activities
6 The HFE process: A systems approach
    6.1 User input
         6.1.1 Sampling users
         6.1.2 Research protocols and informed consent
    6.2 Design criteria and requirement development
    6.3 Device design
         6.3.1 Structuring an approach to design
         6.3.2 Modeling the user interface
    6.4 Design specifications
         6.4.1 Hardware user interface specifications
         6.4.2 Software user interface specifications
         6.4.3 Other useful HFE tools
    6.5 Design evaluation
         6.5.1 Design verification
         6.5.2 Production unit validation
7 Methods and techniques used in the HFE process
    7.1 Cognitive walkthrough
    7.2 Contextual inquiry and observation
    7.3 Design audits
    7.4 Device comparisons and functional analysis
    7.5 Expert reviews
    7.6 Functional analysis
    7.7 Heuristic analysis
    7.8 Interviews
    7.9 Participatory design
    7.10 Prototyping
    7.11 Questionnaires and surveys
    7.12 Simulated clinical environments and field testing
    7.13 Task analysis
         7.13.1 Time-and-motion studies
         7.13.2 Cognitive task analysis
    7.14 Usability testing
    7.15 Use error analysis
    7.16 Workload assessment
8 The complementary role of other types of analysis
    8.1 Risk analysis
    8.2 Cost-benefit analysis
Annexes
A Rationale for the development and provisions of this standard
B Current FDA regulations
C Helpful tips
D References
E Bibliography

Provides an overview of the human factors engineering (HFE) discipline, a discussion of the benefits of HFE, a review of the HFE process and associated analysis and design techniques, and a discussion of implementation issues and relevant national and international standards and regulations.