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  • AAMI TIR59:2017

    Current The latest, up-to-date edition.

    INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  04-08-2017

    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 Terms and definitions
    3 Acronyms
    4 HFE/UE Integration within existing
       DESIGN CONTROLS
    5 Pre DESIGN CONTROLS
    6 DESIGN CONTROLS - General
       [21 CFR 820.30(a)(1)]
    7 Design and development planning
       [21 CFR 820.30 (b)]
    8 DESIGN INPUT [CFR 820.30 (c)]
    9 DESIGN OUTPUT - [21 CFR 820.30 (d)]
    10 Design reviews - [21 CFR 820.30 (e)]
    11 Design VERIFICATION - [CFR 820.30 (f)]
    12 Design VALIDATION - [21 CFR 820.30 (g)]
    13 Design transfer - [CFR 820.30 (h)]
    14 Design changes - [CFR 820.30 (i)]
    15 DESIGN HISTORY FILE - [CFR 820.30 (j)]
    16 POST-MARKET SURVEILLANCE
    ANNEX A (INFORMATIVE) - HFE/UE report
    Bibliography

    Abstract - (Show below) - (Hide below)

    This TIR was developed to provide background and information regarding HFE/UE activities and their corresponding applicability to DESIGN CONTROLS in accordance with 21 CFR 820.30.

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

    Document Type Technical Report
    Publisher Association for the Advancement of Medical Instrumentation
    Status Current

    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
    AAMI TIR50 : 2014 POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    AAMI IEC 62366-1 : 2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    AAMI TIR51 : 2014 HUMAN FACTORS ENGINEERING - GUIDANCE FOR CONTEXTUAL INQUIRY
    ISO 9001:2015 Quality management systems — Requirements
    AAMI/IEC TIR62366-2:2016 MEDICAL DEVICES - PART 2: GUIDANCE ON THE APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
    AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
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