ISO/TC 168 - Prosthetics and orthotics

This document specifies a method of describing and measuring the residual limb after upper limb amputation. It also defines the measurements required for the provision of a prosthesis.

This document primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, these differ in the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off which is relevant to the verification of performance requirements such as strength, durability and service life. This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading. In addition, this document specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features (see NOTE), by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test. These loading conditions are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle. The test loading conditions specified in this document are characterized by standardized formats of these loading and locomotion profiles, applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test. This document specifies Test Ranges (R) by specifying locomotion profiles for the cyclic test in relation to the intended use. According to the concept of the tests of this document, each sample of ankle-foot device or foot unit submitted for test is, nevertheless, free to develop its individual performance under load. This document is suitable for the assessment and testing of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006 (see NOTE). 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 10328:2016, need not be retested to this document. NOTE The lines of action of the heel and forefoot forces generated by the static test procedure for Test Range 4 (R4) specified in this document approach those determining the sagittal plane loading of the test loading conditions I and II for the principal structural tests referring to ISO 10328:2016, without changing the values of the angles of the heel and forefoot platform(s) for the structural tests on ankle-foot devices and foot units specified in ISO 10328:2016.

This document specifies the uses and functions of external lower limb orthoses. It classifies and describes the devices and their components. It permits the systematic classification and description of both the finished orthosis and the components from which it is assembled in a manner that clearly explains their principal characteristics. This document does not specify the materials or manufacturing methods used for the fabrication of lower limb orthoses.

This document defines terms used to describe external limb prostheses. The terms related to the amputation level used to in this document are described in ISO 8549‑4. The types of component used in the construction of prostheses are classified and described in ISO 13405‑1, ISO 13405‑2 and ISO 13405‑3. For the purposes of this document, the abbreviated term ‘prosthetics’ and its derivatives only apply to external limb prosthetics.

This document specifies a method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthosis, moving in plantar- and dorsiflexion direction. This document specifies categories of locomotion profiles to be applied together with appropriate loading profiles, to generate plantar- and dorsiflexion ankle moment loads for the microprocessor-controlled ankle moment units. It also defines which measured outcome of the test allows to claim compliance to this document, and how the compliance is documented in the IFU. This document solely addresses the resistance of microprocessor-controlled ankle moment units in motion. Geometrical constrains like end stops, where motion is stopped instead of sustaining it, can be tested in repetitive quasi static tests instead. A method to derive test parameters for the reliability test of microprocessor-controlled ankle moment units is described. This document is applicable to unilateral ankle-foot orthoses and to bilateral jointed orthoses where either both joints are controlled or where one joint is controlled and the other is not controlled.

This document lists factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation.

This document specifies dimensions of the adult modular systems adapters used in lower limb prosthetic.

This document defines terms relating to orthoses. This document does not include terms for orthoses that only encompass limb segments, as these orthoses are limited mainly to use in the treatment of fractures and in sports medicine. NOTE 1 The types of components used in the construction of orthoses are classified and described in ISO 13404. NOTE 2 For the purposes of this document the abbreviated term ?orthotics' and its derivatives only apply to external orthotics.

This document defines general terms used to describe external limb prostheses and orthoses, and the personnel involved in the practice of prosthetics and orthotics. NOTE 1 The complete range of levels of limb amputation are listed and defined in ISO 8549-2. The complete range of classes of orthoses are listed and defined in ISO 8549-3. This document does not apply to breast, ocular or other external prostheses used to replace other parts of the human body, nor to dental prostheses or orthoses. NOTE 2 For the purposes of this document, the abbreviated term 'prosthetics' and its derivatives only apply to external limb prosthetics. The abbreviated term 'orthotics' and its derivatives only apply to external orthotics.

This document specifies a vocabulary for the description of surgical limb amputations, amputation procedures, and persons who have had an amputation.

This document establishes a method of describing and measuring lower limb amputation stumps. It also lists the measurements required for the provision of a prosthesis.

This document establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.

ISO 21063:2017 specifies the uses and functions of soft orthoses. It also classifies and describes the devices and their components. It does not describe the materials or manufacturing methods used for their fabrication.

ISO 21064:2017 establishes a method of classifying and describing the devices that are used in the field of foot orthotics. It does not describe the materials or manufacturing methods used for their fabrication.

ISO 21065:2017 specifies a vocabulary for the description of the phases of treatment and rehabilitation of persons having a lower limb amputation and the treatments which are used during these phases.

ISO 29783-3:2016 specifies a method of describing abnormal gait patterns resulting from pathology (excluding prosthetic gait) by identifying the deviations from the normal pattern of gait during each sub-phase of the gait cycle. The description of the deviations includes references to abnormal foot contact and abnormalities of joint motion.

ISO/TS 16955:2016 describes quantitative methods to evaluate or assess key performance indicators of prosthetic ankle foot devices. For each method, the set-up and test configurations are described. Also included is a variety of parameters which are derived or calculated from the recorded data.

IMPORTANT ? ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units 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 this International Standard. WARNING ? ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees. ISO 22675:2016 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life. This potential is of particular importance for the assessment of the performance of a variety of recent designs of ankle-foot devices and foot units with specific characteristics that will only develop under realistic conditions of loading. In addition, ISO 22675:2016 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, (see NOTE 2) by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test. The loading conditions addressed in the third paragraph are characterized by a loading profile determined by the resultant vector of the vertical and horizontal (A-P) ground reaction forces and by a locomotion profile determined by the tibia angle. The test loading conditions specified in this International Standard are characterized by standardized formats of these loading and locomotion profiles, to be uniformly applied by the cyclic and static test procedures to each sample of ankle-foot device or foot unit submitted for test.

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.

ISO 27983-2:2015 specifies a vocabulary for the description of prosthetic gait.

ISO 13405-2:2015 specifies a method for describing lower limb prosthetic components.

ISO 13405-1:2015 specifies a means of classifying the components of limb prostheses and their construction.

ISO 13405-3:2015 specifies a method for describing upper-limb prosthetic components.

ISO 29783-1:2008 establishes a vocabulary for the description of normal gait.

ISO 29781:2008 describes the factors to be included when describing the physical activity of a person who has had a lower limb amputation(s) or who has a deficiency of a lower limb segment(s) present at birth.

ISO 13404:2007 establishes a means of classifying and describing external orthoses and the components from which they are assembled.

ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 - 06 15 Orthoses 06 18 - 06 27 Limb prostheses It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components. This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.

ISO/TR 22676:2006 offers guidance on: the specification of the test loading conditions of ISO 22675; the design of appropriate test equipment. Most of the text of ISO/TR 22676:2006 relates to the theoretical and technical background and the design of the equipment.

ISO 8548-5:2003 establishes a method of describing those attributes of a person who has had an amputation which may affect their rehabilitation.

This International Standard specifies test methods for components and assemblies of hip disarticulation prostheses which are arranged at hip and thigh level. It does not apply to other components of lower limb prostheses for which test methods are given in ISO 10328. This International Standard specifies procedures for simplified static and cyclic strength tests in which the anteroposterior (A-P) and medio-lateral (M-L) components of loading are produced in separate tests by the application of test forces in two different test planes. The components of loading produced 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.

Establishes a method of describing upper limb amputation stumps and proposes a standardized system for recording the descriptive information which can be easily incorporated in reports and forms and should also be capable of ready adaptation for computer analysis. Deliberately aims at defining the minimum information to be described.

This method includes only bone deficiencies due to the failure of the formation ability of segments. It bases on anatomic and radiologic statements while ethiologic and epidemiologic factors are excluded. An example for the description of longitudinal deficiencies is given in the annex.

This document defines terms used to describe external limb prostheses and the wearers of external limb prostheses. NOTE 1 The types of component used in the construction of prostheses are classified and described in the ISO 13405 series. NOTE 2 For the purposes of this document, the abbreviated term ?prosthetics' and its derivatives only apply to external limb prosthetics.

ISO 8549-4:2014 specifies a vocabulary for the description of surgical limb amputations, amputation procedures, and persons who have had an amputation.

ISO 29782:2008 describes the factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation.

ISO 22675:2006 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life. In addition, ISO 22675:2006 specifies a static test procedure for prosthetic ankle-foot devices and foot units, consisting of a static proof test and a static ultimate strength test, distinguished, besides other features, by the potential to generate heel and forefoot forces at lines of action conforming to those occurring at the instants of maximum heel and forefoot loading during the cyclic test.

ISO 10328:2005 specifies procedures for static and cyclic strength tests on lower-limb prostheses where, with one exception, compound loadings are produced 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. The tests described in ISO 10328:2005 comprise: principal static and cyclic tests for all components; a separate static test in torsion for all components; 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; 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; 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. The tests described in this ISO 10328:2005 apply to specific types of ankle-disarticulation prostheses, to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses.

ISO 8551:2003 establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.

Describes procedures for static and cyclic strength test for lower-limb prostheses. Specifies the information that shall be provided in the test report which is prepared for each test conducted in accordance with ISO 10328 and ISO 10328-4 and/or ISO 10328-5 and ISO 10328-6.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies types, selection, preparation and alignment of test samples and responsibilities for test preparation.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the values of the test forces and moments for the supplementary structural tests.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the information that must be provided on the test submision document which accompanies each item for testing.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the values of the test forces.

Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies supplementary structural tests.

Contains procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies methods to be used in carrying out principal static and cyclic tests, requirements for accuracy of the tests and criteria to be met in order to secure compliance with this part of ISO 10328.

Gives test configurations for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Defines coordinate systems, the location of a test sample and the position of the line of application of the test force.

Establishes a method for describing upper-limb prosthetic components.