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  • DIN EN ISO 11608-7:2017-10

    Current The latest, up-to-date edition.

    NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Annex ZA (informative) - Relationship between this
             European standard and the essential requirements
             of Directive 93/42/EEC [OJ L 169] aimed to be
             covered
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test methods
    6 Test report
    7 Information supplied by the manufacturer
    Annex A (informative) - Measuring vision and visual
            impairment: Functional vision and visual acuity
    Annex B (informative) - Guidance for developing
            instructions for use for persons with visual
            impairment
    Annex C (informative) - Process for establishing a
           specification, test methods and verification
           related to 5.1
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

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

    DIN EN ISO 11608-1 E : 2015 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
    ISO/IEC 18004:2015 Information technology Automatic identification and data capture techniques QR Code bar code symbology specification
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    ISO 11608-5:2012 Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions
    ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
    ISO 24502:2010 Ergonomics Accessible design Specification of age-related luminance contrast for coloured light
    ISO 24500:2010 Ergonomics Accessible design Auditory signals for consumer products
    DIN EN 62366-1 : 2017 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
    DIN CEN ISO/TR 22411;DIN SPEC 33421:2014-12 ERGONOMICS DATA AND GUIDELINES FOR THE APPLICATION OF ISO/IEC GUIDE 71 TO PRODUCTS AND SERVICES TO ADDRESS THE NEEDS OF OLDER PERSONS AND PERSONS WITH DISABILITIES (ISO/TR 22411:2008)
    VDE 0750-241-1 : 2017 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015 + COR1:2016)
    EN ISO 11608-1:2015 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 11156:2011 Packaging — Accessible design — General requirements
    ISO/TR 22411:2008 Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    EN 62366-1:2015/AC:2015 MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015)
    DIN CEN ISO/TR 22411;DIN SPEC 33421:2014-12 ERGONOMICS DATA AND GUIDELINES FOR THE APPLICATION OF ISO/IEC GUIDE 71 TO PRODUCTS AND SERVICES TO ADDRESS THE NEEDS OF OLDER PERSONS AND PERSONS WITH DISABILITIES (ISO/TR 22411:2008)
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