{"id":277983,"date":"2024-10-19T18:43:42","date_gmt":"2024-10-19T18:43:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-103282016\/"},"modified":"2024-10-25T15:15:26","modified_gmt":"2024-10-25T15:15:26","slug":"bs-en-iso-103282016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-103282016\/","title":{"rendered":"BS EN ISO 10328:2016"},"content":{"rendered":"
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IMPORTANT This International Standard is suitable<\/i> 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.<\/p>\n<\/blockquote>\n

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WARNING This International Standard is not suitable<\/i> 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.<\/p>\n<\/blockquote>\n

This International Standard 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.<\/p>\n

The tests described in this International Standard comprise<\/p>\n

    \n
  • \n

    principal static and cyclic tests for all components;<\/p>\n<\/li>\n

  • \n

    a separate static test in torsion for all components;<\/p>\n<\/li>\n

  • \n

    separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single components including ankle units or ankle attachments and all foot units as single components;<\/p>\n<\/li>\n

  • \n

    a separate static ultimate strength test in maximum knee flexion on knee joints and associated parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the flexion stop on a complete prosthesis;<\/p>\n<\/li>\n

  • \n

    separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the extended position of the knee unit or knee-shin-assembly.<\/p>\n<\/li>\n<\/ul>\n

    The tests described in this International Standard apply to specific types of ankle-disarticulation prostheses (see NOTE 2), to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses (see NOTE 3).<\/p>\n

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    NOTE 1 The tests can be performed on complete structures, on part structures or on individual components.<\/p>\n<\/blockquote>\n

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    NOTE 2 The tests only apply to ankle-disarticulation prostheses which include (foot) components of prosthetic ankle-foot devices taken from the normal production line.<\/p>\n<\/blockquote>\n

    \n

    NOTE 3 The distal part comprises the knee unit, the ankle-foot device and all parts between. Tests on hip units are described in ISO 15032.<\/p>\n<\/blockquote>\n

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    PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
    4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
    5<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC [OJ L 169] aimed to be covered
    Table ZA.1 \u2014 Correspondence between this European standard and Annex I of Directive 93\/42\/EEC [OJ L 169] <\/td>\n<\/tr>\n
    11<\/td>\nForeword <\/td>\n<\/tr>\n
    12<\/td>\nIntroduction <\/td>\n<\/tr>\n
    13<\/td>\n1 Scope
    2 Normative references <\/td>\n<\/tr>\n
    14<\/td>\n3 Terms and definitions
    4 Designations and symbols of test forces and moments <\/td>\n<\/tr>\n
    15<\/td>\n5 Strength and related performance requirements and conditions of use <\/td>\n<\/tr>\n
    17<\/td>\n6 Coordinate systems and test configurations
    6.1 General
    6.2 Axes of coordinate systems
    6.3 Reference planes
    6.3.1 General
    6.3.2 Top reference plane, T
    6.3.3 Knee reference plane, K <\/td>\n<\/tr>\n
    18<\/td>\n6.3.4 Ankle reference plane, A
    6.3.5 Bottom reference plane, B <\/td>\n<\/tr>\n
    19<\/td>\n6.4 Reference points <\/td>\n<\/tr>\n
    20<\/td>\n6.5 Test force
    6.6 Load line
    6.7 Longitudinal axis of the foot and effective joint centres and centrelines
    6.7.1 General
    6.7.2 Longitudinal axis of the foot
    6.7.3 Effective ankle-joint centre <\/td>\n<\/tr>\n
    22<\/td>\n6.7.4 Effective ankle-joint centreline
    6.7.5 Effective knee-joint centreline <\/td>\n<\/tr>\n
    23<\/td>\n6.7.6 Effective knee-joint centre
    6.8 Reference distances
    6.8.1 Offsets
    6.8.2 Combined offsets
    6.8.3 Effective lever arms LA and LK
    6.8.4 Distance LBT
    7 Test loading conditions and test loading levels
    7.1 Test loading conditions
    7.1.1 General <\/td>\n<\/tr>\n
    24<\/td>\n7.1.2 Test loading conditions of principal structural tests
    7.1.3 Test loading conditions of separate structural tests
    7.2 Test loading levels <\/td>\n<\/tr>\n
    25<\/td>\n8 Values of test loads, dimensions and cycles <\/td>\n<\/tr>\n
    32<\/td>\n9 Compliance
    9.1 General <\/td>\n<\/tr>\n
    33<\/td>\n9.2 Selection of tests required to claim compliance with this International Standard
    9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot devices or foot units, required to claim compliance with this International Standard
    9.3.1 General
    9.3.2 Particular arrangements concerning the ankle-foot device or foot unit
    9.3.3 Particular arrangements and requirements concerning the part required to connect the ankle-foot device or foot unit to the remainder of the prosthetic structure <\/td>\n<\/tr>\n
    34<\/td>\n9.4 Number of tests and test samples required to claim compliance with this International Standard
    9.5 Multiple use of test samples
    9.5.1 General
    9.5.2 Restriction <\/td>\n<\/tr>\n
    35<\/td>\n9.6 Testing at particular test loading levels not specified in this International Standard <\/td>\n<\/tr>\n
    37<\/td>\n10 Test samples
    10.1 Selection of test samples
    10.1.1 General <\/td>\n<\/tr>\n
    38<\/td>\n10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot <\/td>\n<\/tr>\n
    39<\/td>\n10.2 Types of test samples
    10.2.1 Complete structure <\/td>\n<\/tr>\n
    41<\/td>\n10.2.2 Partial structure
    10.2.3 Any other structure
    10.3 Preparation of test samples <\/td>\n<\/tr>\n
    42<\/td>\n10.4 Identification of test samples <\/td>\n<\/tr>\n
    43<\/td>\n10.5 Alignment of test samples
    10.5.1 Test samples for principal tests and separate tests on knee locks
    10.5.2 Test samples for separate tests on ankle-foot devices and foot units
    10.5.3 Test samples for separate static ultimate strength tests in maximum knee flexion for knee joints and associated parts <\/td>\n<\/tr>\n
    44<\/td>\n10.5.4 Test samples for separate tests on knee locks
    10.6 Worst-case alignment position of test samples <\/td>\n<\/tr>\n
    45<\/td>\n11 Responsibility for test preparation <\/td>\n<\/tr>\n
    46<\/td>\n12 Test submission document
    12.1 General requirements <\/td>\n<\/tr>\n
    47<\/td>\n12.2 Information required for test samples
    12.2.1 All test samples
    12.2.2 Test samples for tests on ankle-foot devices and foot units
    12.2.3 Test samples for static ultimate strength tests in maximum knee flexion for knee joints and associated parts
    12.3 Information required for tests
    12.3.1 General
    12.3.2 For all tests <\/td>\n<\/tr>\n
    48<\/td>\n12.3.3 For static tests in torsion and on ankle-foot devices and foot units
    12.3.4 For static ultimate strength tests
    12.3.5 For cyclic tests
    12.3.6 For tests in torsion
    12.3.7 For tests on ankle-foot devices and foot units <\/td>\n<\/tr>\n
    49<\/td>\n13 Equipment
    13.1 General
    13.2 Equipment for the principal tests specified in 16.2 and 16.3
    13.2.1 End attachments <\/td>\n<\/tr>\n
    51<\/td>\n13.2.2 Jig (optional) <\/td>\n<\/tr>\n
    52<\/td>\n13.2.3 Test equipment <\/td>\n<\/tr>\n
    54<\/td>\n13.3 Equipment for the separate static test in torsion specified in 17.1
    13.3.1 Test equipment
    13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2
    13.4.1 Test equipment <\/td>\n<\/tr>\n
    58<\/td>\n13.5 Equipment for the separate static ultimate strength test in maximum knee flexion for knee joints and associated parts specified in 17.3
    13.5.1 Extension pieces
    13.5.2 Test equipment to perform static compression loading \u2013 (Compression testing machine or other equipment)
    13.6 Equipment for the separate tests on knee locks specified in 17.4
    13.6.1 End attachments
    13.6.2 Jig (optional)
    13.6.3 Test equipment <\/td>\n<\/tr>\n
    59<\/td>\n14 Accuracy
    14.1 General
    14.2 Accuracy of equipment
    14.3 Accuracy of procedure <\/td>\n<\/tr>\n
    60<\/td>\n15 Test principles
    15.1 General
    15.2 Static test procedure
    15.3 Cyclic test procedure
    16 Test procedures \u2013 Principal structural tests
    16.1 Test loading requirements
    16.1.1 Preparation for test loading
    16.1.2 Application of test loading <\/td>\n<\/tr>\n
    62<\/td>\n16.2 Principal static test procedure
    16.2.1 Principal static proof test <\/td>\n<\/tr>\n
    67<\/td>\n16.2.2 Principal static ultimate strength test <\/td>\n<\/tr>\n
    71<\/td>\n16.3 Principal cyclic test procedure
    16.3.1 General requirements
    16.3.2 Test method <\/td>\n<\/tr>\n
    75<\/td>\n16.3.3 Performance requirements <\/td>\n<\/tr>\n
    76<\/td>\n16.3.4 Compliance conditions <\/td>\n<\/tr>\n
    80<\/td>\n17 Test procedures\u00a0\u2014 Separate structural tests
    17.1 Separate static test in torsion
    17.1.1 General
    17.1.2 Purpose of test
    17.1.3 Test method <\/td>\n<\/tr>\n
    82<\/td>\n17.1.4 Performance requirements
    17.1.5 Compliance conditions <\/td>\n<\/tr>\n
    84<\/td>\n17.2 Separate tests on ankle-foot devices and foot units
    17.2.1 General
    17.2.2 Purpose of tests
    17.2.3 Separate static proof test for ankle-foot devices and foot units <\/td>\n<\/tr>\n
    88<\/td>\n17.2.4 Separate static ultimate strength test for ankle-foot devices and foot units <\/td>\n<\/tr>\n
    93<\/td>\n17.2.5 Separate cyclic test for ankle-foot devices and foot units <\/td>\n<\/tr>\n
    98<\/td>\n17.3 Separate static ultimate strength test in maximum knee flexion for knee joints and associated parts
    17.3.1 General
    17.3.2 Purpose of test
    17.3.3 Applicability of the test to specific test samples <\/td>\n<\/tr>\n
    99<\/td>\n17.3.4 Test method <\/td>\n<\/tr>\n
    100<\/td>\n17.3.5 Performance requirement
    17.3.6 Compliance conditions <\/td>\n<\/tr>\n
    101<\/td>\n17.4 Separate tests on knee locks
    17.4.1 General <\/td>\n<\/tr>\n
    102<\/td>\n17.4.2 Purpose of tests
    17.4.3 Separate static proof test for knee locks <\/td>\n<\/tr>\n
    106<\/td>\n17.4.4 Separate static ultimate strength test for knee locks <\/td>\n<\/tr>\n
    108<\/td>\n17.4.5 Separate cyclic test for knee locks <\/td>\n<\/tr>\n
    117<\/td>\n18 Test laboratory\/facility log
    18.1 General requirements
    18.2 Specific requirements
    19 Test report
    19.1 General requirements <\/td>\n<\/tr>\n
    118<\/td>\n19.2 Specific requirements
    19.3 Options
    20 Classification and designation
    20.1 General
    20.2 Examples of classification and designation <\/td>\n<\/tr>\n
    119<\/td>\n21 Labelling
    21.1 General <\/td>\n<\/tr>\n
    120<\/td>\n21.2 Use of mark \u201c*)\u201d and warning symbol
    21.3 Examples of label layout
    21.4 Label placement <\/td>\n<\/tr>\n
    122<\/td>\nAnnex\u00a0A (informative) Description of internal loads and their effects <\/td>\n<\/tr>\n
    126<\/td>\nAnnex\u00a0B (informative) Reference data for the specification of test loading conditions and test loading levels of principal cyclic tests <\/td>\n<\/tr>\n
    130<\/td>\nAnnex\u00a0C (informative) Guidance on the application of an alternative static ultimate strength test <\/td>\n<\/tr>\n
    131<\/td>\nAnnex\u00a0D (normative) Guidance on the application of an additional test loading levels P6, P7 and P8 <\/td>\n<\/tr>\n
    134<\/td>\nAnnex\u00a0E (informative) Summary of the records to be entered in the test laboratory\/facility log <\/td>\n<\/tr>\n
    149<\/td>\nAnnex\u00a0F (informative) Background information on the loading profiles generated by test equipment according to 13.4.1.2 for separate cyclic tests for ankle-foot devices and foot units according to 17.2.5.1 <\/td>\n<\/tr>\n
    151<\/td>\nAnnex\u00a0G (informative) Reference to the essential principles of safety and performance of medical devices according to ISO\/TR\u00a016142 <\/td>\n<\/tr>\n
    152<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

    Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods<\/b><\/p>\n\n\n\n\n
    Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
    BSI<\/b><\/a><\/td>\n2016<\/td>\n156<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277986,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277983","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/277983","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/277986"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277983"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277983"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277983"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}