Standard No.:	GB/T 43350-2023
English Name:	Prosthetics—Quantification of physical parameters of ankle foot devices and foot units
Chinese Name:	假肢 踝足装置和足部组件物理参数的量化
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	GB    National Standard
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	SAMR; SAC
Issued on:	2023-11-27
Implemented on:	2024-3-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	12500 words
Price(USD):	375.0
Delivery:	via email in 1~5 business day

Prosthetics - Quantification of physical parameters of ankle foot devices and footunits 1 Scope This document 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. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 30659-2014 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006, IDT) ISO 10328 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods Note: GB/T 31181-2014, Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006, IDT) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 heel, mid-foot and toe characteristics physical parameters to describe the response of the ankle foot device under load after heel strike in mid stance and prior toe off 3.2 roll-over characteristics physical parameters to describe the sagittal plane properties of the ankle foot device relevant for the patient during stance-phase 3.3 Full contact motion physical parameter to describe the angular range of motion of the shin where the heel and the toe are in contact with the ground simultaneously 3.4 torsional characteristic physical parameter to describe the rotational response of the ankle foot device under load and additional torque in transversal plane 3.5 Frontal plane characteristics physical parameter to describe the frontal plane response of the ankle foot device during roll over on four different tilted ground angles in frontal plane 4 Symbols and abbreviated terms Symbols and abbreviated terms are those used in ISO 10328 and ISO 22675. 5 Requirements To determine comprehensive ankle foot device performance and to claim compliance with this Technical Specification, all parameters shall be quantified and the strength requirements specified in GB/T 30659-2014, 4.4, shall be met. If an ankle foot device allows for different adjustments on key performance indicators, the manufacturer/submitter shall define the settings relevant for quantification. To claim compliance with this Technical Specification, all parameters shall be quantified in the specific adjustments and the strength requirements specified in GB/T 30659-2014, 4.4, shall be met. Samples for the quantification shall be from the same production batch as those for strength testing. If not otherwise specified in this Technical Specification, the test preparation as described in ISO 10328 or ISO 22675 shall apply. Note: The order of tests given in Table A.1 minimizes the effort for test setup and configuration. 6 Setup conditions Use the coordinate system and test configurations specified in ISO 22675:2016, Clause 6, except PT is located at 700 mm height on a line which is located at midfoot and parallel to the u-axis. The test methods specified are defined for a prosthetic foot of size 26 cm and appropriate for a 70 kg amputee. For all the described test methods, a force moment sensor shall be positioned above midfoot and at the height of 500 mm, see Figure 1. In order to quantify the influence of compliant components between knee and ankle foot device, the force moment sensor is positioned at a height of 500 mm. A displacement sensor rigidly connected to the force moment sensor parallel to u-axis shall be used to record vertical displacement (su). An angular sensor rigidly connected to the force moment sensor perpendicular to u-axis shall be used to record the torsional angle (αu). Using the data acquired by the sensors, the following characteristics shall be calculated: ——Stiffness at static plate angle ——Lever arm length at static plate angle Note: Calculations in ranges of Fu < 10 % Fumax to be considered carefully because of noise. ——Lever arm length changes at static plate angle ——Effective foot length at tilting plate ——Full contact motion at tilting plate ——Energy at static plate angle ——Torsional stiffness ——Torsional angular range ——Effective foot width at tilting plate 7 Quantification 7.1 Heel, mid-foot and toe characteristics 7.1.1 Procedure Perform the quantification of the heel, mid-foot and toe characteristics using the geometrical configuration of foot and foot platform described for loading in ISO 22675:2016, 13.4.1.3, using plate angles of -7.5° and 10° in addition (see Figure 2). The peak force in the loading profile for quantification of the heel and toe characteristics (see Figure 3) shall be in accordance with 120 % (824 N) of the maximum body weight for which the ankle foot device is designed The loading and unloading time shall be within (1 ± 0.1) s. Perform the quantification of mid-foot characteristic as stated above but with the foot plate horizontal (0°) and the peak force in the loading profile (see Figure 3) in accordance with 200 % (1373 N) of the maximum body weight for which the ankle foot device is designed. The loading and unloading time shall be within (1 ± 0.1) s.