Skip to content
Please enter a keyword to search

  • ISO 10328:2016

    Current The latest, up-to-date edition.

    Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  26-05-2016

    Publisher:  International Organization for Standardization

    Add To Cart

    Abstract - (Show below) - (Hide below)

    IMPORTANT - ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to ISO 22675:2016.

    WARNING - ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees.

    ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.

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

    Committee ISO/TC 168
    Development Note Supersedes ISO 10328-1, ISO 10328-2, ISO 10328-3, ISO 10328-4, ISO 10328-5, ISO 10328-6, ISO 10328-7 and ISO 10328-8. (09/2006) Supersedes ISO/DIS 10328. (05/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    I.S. EN ISO 22523:2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
    BS EN ISO 22523:2006 External limb prostheses and external orthoses. Requirements and test methods
    I.S. EN ISO 22675:2016 PROSTHETICS - TESTING OF ANKLE-FOOT DEVICES AND FOOT UNITS - REQUIREMENTS AND TEST METHODS (ISO 22675:2016)
    EN ISO 22523 : 2006 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS (ISO 22523:2006)
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    UNE-EN ISO 22675:2017 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
    03/317861 DC : DRAFT OCT 2003 EN ISO 22523 - EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    DIN EN ISO 22523:2007-04 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
    ISO/TR 22676:2006 Prosthetics Testing of ankle-foot devices and foot units Guidance on the application of the test loading conditions of ISO 22675 and on the design of appropriate test equipment
    ISO/TS 16955:2016 Prosthetics — Quantification of physical parameters of ankle foot devices and foot units
    13/30251846 DC : 0 BS ISO 16955 - PROSTHETICS - QUANTIFICATION OF PHYSICAL PARAMETERS OF ANKLE FOOT DEVICES AND FOOT UNITS
    ISO 22675:2016 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
    ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
    BS EN ISO 22675:2006 Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods
    EN ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
    PD ISO/TS 16955:2016 Prosthetics. Quantification of physical parameters of ankle foot devices and foot units

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

    ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods
    ISO 15032:2000 Prostheses — Structural testing of hip units
    ISO 8549-1:1989 Prosthetics and orthotics Vocabulary Part 1: General terms for external limb prostheses and external orthoses
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    ISO 22675:2016 Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective