• There are no items in your cart

AAMI HE74 : 2001 : R2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

09-01-2021

Language(s)

English

Published date

01-01-2009

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.

Committee
HE
DevelopmentNote
Supersedes AAMI HE48. (02/2010)
DocumentType
Standard
Pages
48
ProductNote
Reconfirmed 2009
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
AAMI HE48 : 1993 HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES
ISO 9241-17:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 17: Form filling dialogues
ISO 9241-10:1996 Ergonomic requirements for office work with visual display terminals (VDTs) Part 10: Dialogue principles
MIL-HDBK-46855 Revision A:1999 HUMAN ENGINEERING PROGRAM - PROCESS AND PROCEDURES
CLSI GP19 P : 1994 LABORATORY INSTRUMENTS AND DATA MANAGEMENT SYSTEMS: DESIGN OF SOFTWARE USER INTERFACES AND SOFTWARE SYSTEMS VALIDATION, OPERATION, AND MONITORING
CFR 45(PTS1-199) : OCT 2017 PUBLIC WELFARE - SUBTITLE A - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL ADMINISTRATION - SUBTITLE B - REGULATIONS RELATING TO PUBLIC WELFARE
ISO 9241-12:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 12: Presentation of information
MIL-HDBK-759 Revision C:1995 HANDBOOK FOR HUMAN ENGINEERING DESIGN GUIDELINES
MIL-HDBK-1908 Revision B:1999 Definitions of Human Factors Terms
ISO 9241-16:1999 Ergonomic requirements for office work with visual display terminals (VDTs) Part 16: Direct manipulation dialogues
ISO 9002:1994 Quality systems — Model for quality assurance in production, installation and servicing
ISO 9241-14:1997 Ergonomic requirements for office work with visual display terminals (VDTs) — Part 14: Menu dialogues
ISO 9241-15:1997 Ergonomic requirements for office work with visual display terminals (VDTs) Part 15: Command dialogues
ANSI HFS100 : 1988 HUMAN FACTORS ENGINEERING OF VISUAL DISPLAY TERMINAL WORKSTATIONS - AMERICAN NATIONAL STANDARD FOR
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 9001:2015 Quality management systems — Requirements
MIL-STD-1472 Revision G:2012 HUMAN ENGINEERING
AAMI ISO 13488 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9002
AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 9241-13:1998 Ergonomic requirements for office work with visual display terminals (VDTs) — Part 13: User guidance

View more information
US$103.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.