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  • AAMI HE75 : 2009

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  27-03-2020

    Language(s):  English

    Published date:  01-01-2013

    Publisher:  Association for the Advancement of Medical Instrumentation

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    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 Standard
    Product Note Reconfirmed 2009
    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    Status Superseded
    Superseded By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
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