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  • AAMI HE48 : 1993

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  21-01-2010

    Language(s):  English

    Published date:  01-01-1993

    Publisher:  Association for the Advancement of Medical Instrumentation

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

    Foreword
    1 Scope
    2 Normative references
    3 Definitions
    4 Purpose
    5 Human factors engineering process
    6 General recommendations for human factors
       engineering design
    7 The human factor and the work space
    8 Signs, symbols, and markings
    9 Controls
    10 Displays
    11 Alarms and signals
    12 User-computer interface
    13 References
    Annex 1 (Informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the controls, displays, consoles, size, weight, and general user interface design of medical devices.

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

    Committee HE
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    02/562586 DC : DRAFT JUN 2002 BS EN 60601-1-8 - MEDICAL ELECTRICAL EQUIPMENT - PART 8-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - ALARM SYSTEMS - REQUIREMENTS, TEST AND GUIDELINES - GENERAL REQUIREMENTS AND GUIDELINES FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND IN MEDICAL ELECTRICAL SYSTEMS
    CSA Z8185 : 2008 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    03/304741 DC : DRAFT APR 2003 IEC 60601-1-6 ED.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD - USABILITY
    CSA Z8185 : 2008(R2013) RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    AAMI IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    AAMI HE74 : 2001 HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
    CSA C22.2 No. 60601.1.8 : 2008 : R2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    AAMI HE74 : 2001 : R2009 HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES
    I.S. EN 62366-1:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    I.S. EN 62366-1:2015&AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    BS EN 60601-1-8 : 2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006)
    EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
    CSA C22.2 No. 60601.1.8 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    CSA IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    I.S. EN ISO 8185:2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    15/30300279 DC : 0 BS ISO 80601-2-74 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-74: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT
    04/30088533 DC : DRAFT MARCH 2004 BS EN ISO 8185 - RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    BS EN 62366 : 2008 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    AAMI IEC 62366 : 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    CSA IEC 62366 : 2014 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    I.S. EN 60601-1-8:2007 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    ASTM F 1456 : 2001 Standard Specification for Minimum Performance and Safety Requirements for Capnometers
    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
    EN 62366-1:2015/AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
    EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
    UNI EN ISO 8185 : 2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    CAN/CSA-C22.2 NO. 60601-1-8:08 (R2018) Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (Adopted IEC 60601-1-8:2006, second edition, 2006-10) | Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d\'alarme des appareils et des systèmes électromédicaux (norme IEC 60601-1-8:2006 adoptée, deuxième édition, 2006-10)
    14/30244508 DC : 0 BS EN 62366-1 - MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    BS EN ISO 8185:2007 Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
    BS EN 62366-1:2015 Medical devices Application of usability engineering to medical devices
    ANSI/AAMI/IEC 60601-1-8:2006/A2:2021 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
    ASTM F 1452 : 2001 Standard Specification for Minimum Performance and Safety Requirements for Anesthetic Gas Monitors
    I.S. EN 62366:2009 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    DIN EN ISO 8185:2009-07 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS

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

    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    AAMI BP23 : 1986 BLOOD PRESSURE TRANSDUCERS - INTERCHANGEABILITY AND PERFORMANCE OF RESISTIVE BRIDGE TYPE
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    AAMI DF2 : 3ED 96 CARDIAC DEFIBRILLATOR DEVICES
    MIL-HDBK-759 Revision C:1995 HANDBOOK FOR HUMAN ENGINEERING DESIGN GUIDELINES
    ANSI Z1979.8 : 1979 ANESTHESIA MACHINES FOR HUMAN USE, MINIMUM PERFORMANCE AND SAFETY REQUIREMENTS FOR COMPONENTS & SYSTEMS OF CONTINUOUS FLOW,
    AAMI MIR2 : 1992 GUIDELINE FOR ESTABLISHING AND ADMINISTERING MEDICAL INSTRUMENTATION MAINTENANCE PROGRAMS
    ICC A117.1 : 2009 ACCESSIBLE AND USABLE BUILDINGS AND FACILITIES
    ISO 68:1973 ISO general purpose screw threads Basic profile
    DIN 30600:1985-11 GRAPHICAL SYMBOLS - REGISTRATION, DESIGNATION
    MIL-STD-1908 Base Document:1992 DEFINITION OF HUMAN FACTOR TERMS (METRIC)
    ANSI HFS100 : 1988 HUMAN FACTORS ENGINEERING OF VISUAL DISPLAY TERMINAL WORKSTATIONS - AMERICAN NATIONAL STANDARD FOR
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    DOD-HDBK-743 Revision A:1991 ANTHROPOMETRY OF U.S. MILITARY PERSONNEL (METRIC)
    IEC 60417H:1987 Eighth supplement.
    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 725:2009 ISO inch screw threads Basic dimensions
    AAMI ECGC : 1983 ECG CONNECTORS
    ANSI Z79.6 : 1975 BREATHING TUBES,
    DIN 66009:1977-09 FONT B FOR OPTICAL CHARACTER RECOGNITION - CHARACTERS, NOMINAL DIMENSIONS, AND FORMAT
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