Skip to content
Please enter a keyword to search

  • AAMI HE75 : 2009(R2013)

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES

    Available format(s): 

    Superseded date:  27-03-2020

    Language(s): 

    Published date:  10-08-2018

    Publisher:  Association for the Advancement of Medical Instrumentation

    Sorry this product is not available in your region.

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Acknowledgments
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Definitions and abbreviations
    General Considerations and Principles
    4 General principles
    5 Managing the risk of use error
    6 Basic human skills and abilities
    7 Anthropometry and biomechanics
    8 Environmental considerations
    9 Usability testing
    10 Signs, symbols, and markings
    11 User documentation
    12 Packaging design
    13 Design for post-market issues
    14 Cross-cultural/cross-national design
    15 Alarm design
    16 Accessibility considerations
    Design Elements
    17 Connectors and connections
    18 Controls
    19 Visual displays
    20 Use of automation
    21 Software-user interfaces
    Integrated Solutions
    22 Hand tool design
    23 Workstations
    24 Design of mobile medical devices
    25 Home health care
    Annexes
    A Statistical justification for sample sizes in
      usability testing

    Abstract - (Show below) - (Hide below)

    Specifies a broad range of human factors engineering (HFE) topics in a structured format.

    General Product Information - (Show below) - (Hide below)

    Committee HE
    Development Note Supersedes AAMI HE48. (02/2010) Also available in CD-ROM format. (04/2016) Also available in a set of Book and CD. (04/2017)
    Document Type Revision
    Product Note Reconfirmed 2013 PDF has been updated Price has been updated
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 9241-11:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 11: Guidance on usability
    ISO 9186:2001 Graphical symbols Test methods for judged comprehensibility and for comprehension
    IEC 60245-1:2003+AMD1:2007 CSV Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
    ANSI S12-2 : 2008 CRITERIA FOR EVALUATING ROOM NOISE
    ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
    ISO 68-2:1998 ISO general purpose screw threads — Basic profile — Part 2: Inch screw threads
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    MIL-HDBK-759 Revision C:1995 HANDBOOK FOR HUMAN ENGINEERING DESIGN GUIDELINES
    IEEE 802.15.4-2011 IEEE Standard for Local and metropolitan area networks--Part 15.4: Low-Rate Wireless Personal Area Networks (LR-WPANs)
    ANSI/AAMI/ISO 15223-1:2016 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
    ISO/TR 18529:2000 Ergonomics Ergonomics of human-system interaction Human-centred lifecycle process descriptions
    IEC 60601-1-10:2007+AMD1:2013 CSV Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    IEEE 802.11-2016 IEEE Standard for Information technology--Telecommunications and information exchange between systems Local and metropolitan area networks--Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications
    ISO 9241-7:1998 Ergonomic requirements for office work with visual display terminals (VDTs) Part 7: Requirements for display with reflections
    ANSI INCITS 354 : 2001 INFORMATION TECHNOLOGY - COMMON INDUSTRY FORMAT FOR USABILITY TEST REPORTS
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    ANSI S3.34:1986 GUIDE FOR THE MEASUREMENT AND EVALUATION OF HUMAN EXPOSURE TO VIBRATION TRANSMITTED TO THE HAND
    CGA C 9 : 2013 STANDARD COLOR MARKING OF COMPRESSED GAS CONTAINERS FOR MEDICAL USE
    AAMI IEC TIR 60878 : 2003 GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC 60227-1:2007 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements
    DEFSTAN 00-25(PT19)/1(2004) : 2004 HUMAN FACTORS FOR DESIGNERS OF SYSTEMS - PART 19: HUMAN ENGINEERING DOMAIN
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ISO 216:2007 Writing paper and certain classes of printed matter Trimmed sizes A and B series, and indication of machine direction
    ISO 68-1:1998 ISO general purpose screw threads — Basic profile — Part 1: Metric screw threads
    ISO/IEC 9995-1:2009 Information technology — Keyboard layouts for text and office systems — Part 1: General principles governing keyboard layouts
    AAMI EC53 : 2013 ECG TRUNK CABLES AND PATIENT LEADWIRES
    ISO 9186-1:2014 Graphical symbols Test methods Part 1: Method for testing comprehensibility
    CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
    NASA STD 3000 VOL 2 : 1995 MAN-SYSTEMS INTEGRATION STANDARDS - VOLUME 2
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    IEC 60601-2-38:1996 Medical electrical equipment - Part 2: Particular requirementsfor the safety of electrically operated hospital beds
    ISO 9186-2:2008 Graphical symbols — Test methods — Part 2: Method for testing perceptual quality
    IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    EN 1089-3:2011 Transportable gas cylinders - Gas cylinder identification (excluding LPG) - Part 3: Colour coding
    ANSI/HIMA MD70.1 : 1983 MEDICAL LUER TAPER FITTINGS - PERFORMANCE STANDARD
    CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
    CGA V 5 : 2008(R2013) DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS)
    MIL-STD-1472 Revision G:2012 HUMAN ENGINEERING
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
    NASA STD 3000 VOL 1 : 1995 MAN-SYSTEMS INTEGRATION STANDARDS - VOLUME 1
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    AAMI EC13 : 2002 CARDIAC MONITORS, HEART RATE METERS AND ALARMS
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    ISO 13407:1999 Human-centred design processes for interactive systems
    DIN 13252:1984-06 INHALATIONAL ANAESTHETIC APPARATUS, REQUIREMENTS FOR SAFETY AND TESTING
    ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
    ISO/TR 16982:2002 Ergonomics of human-system interaction Usability methods supporting human-centred design
    View more information

    • 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, flexibile and cost effective