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  • AAMI TIR49 : 2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  18-04-2020

    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
    Foreword
    Introduction
    1 Scope
    2 Using this document
    3 Definitions
    4 The human performance goal of training and instruction
    5 A systematic approach to designing training and
      instructions
    6 Guidance on media selection
    7 Design guidance for use of instructions and training media
    8 Case study: Development of an effective training curriculum
      for a complex medical device used in the home environment
    Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies a relevant source of information, design criteria, and guidelines for the instructional and training materials and processes intended to accompany medical devices used in a non-clinical environment, which for the purpose of this document, is defined as an environment other than a facility where a health professional is continually present whenever a patient is present.

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

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    Status Superseded
    Superseded By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

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

    15/30328959 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    PD IEC/TR 62366-2:2016 Medical devices Guidance on the application of usability engineering to medical devices
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    14/30290166 DC : 0 BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

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

    ISO 9241-110:2006 Ergonomics of human-system interaction Part 110: Dialogue principles
    ANSI/AAMI HA60601-1-11:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
    ISO/TR 9241-100:2010 Ergonomics of human-system interaction — Part 100: Introduction to standards related to software ergonomics
    AAMI IEC 62366 : 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    ISO 14915-1:2002 Software ergonomics for multimedia user interfaces Part 1: Design principles and framework
    ISO 14915-3:2002 Software ergonomics for multimedia user interfaces Part 3: Media selection and combination
    AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
    ISO 14915-2:2003 Software ergonomics for multimedia user interfaces — Part 2: Multimedia navigation and control
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