GB/T 18375-2024Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting.

This document replaces GB/T 18375.1-2001 "Structural inspection of prostheses for lower limbs Part 1: Test configuration" GB/T 18375.2-2001 "Structural inspection of lower limb prostheses Part 2: Test specimens", GB/T 18375.3-2001 "Prostheses Structural inspection of prostheses for lower limbs Part 3: Inspection of the main structure" and GB/T 18375.4-2001 "Structural inspection of prostheses for lower limbs" GB/T 18375.5-2004 "Structural inspection of prostheses for lower limbs Part 5: Loading parameters in the inspection of the main structure" Part 6: Auxiliary structure inspection" and GB/T 18375.6-2004 "Structural inspection of prostheses for lower limbs Part 6: Auxiliary structure inspection" Loading parameters", GB/T 18375.7-2004 "Structural inspection of prostheses for lower limbs Part 7: Test submission documents", GB/T 18375.8-2004 "Structural inspection of prostheses for lower limbs Part 8: Inspection report". Compared with the original document, in addition to the structural adjustment in addition to the integration and editorial changes, the main technical changes are as follows.

a) The 8 files of the previous version were merged into one file, the overall file structure was adjusted, and the test process was refined describe;

b) Change the description of test load levels A60, A80, A100 to test load levels P3, P4, P5 (see 7.2.3, Table 4, Table 6, Table 7,

Table 8, Table 9, Table 10, Table 12, Table 13, Table 14, Appendix A, 4.4.2 of GB/T 18375.3-2001, Table 1, GB/T 18375.4-

2001 Table 1, Table 4, Table 5, Table 6, Appendix A, GB/T 18375.6-2004 Table 1, Table 8), and increase the test load level P6, P7 and P8 (see Appendix C);

c) Added test flow chart (see Figure 14, Figure 15, Figure 16, Figure 17, Figure 18, Figure 19, Figure 20, Figure 21, Figure 22, Figure 23, Figure 24,

Figure 25, Figure 26, Figure 27, Figure 28);

d) Added the requirements for the logs of testing laboratories (or inspection departments) (see Chapter 18) and the logs of testing laboratories (or inspection departments).

Record summary (see Appendix F);

e) Added the application guidance of the alternative static ultimate strength test (see Appendix D);

f) The contents of the sample data page of the test report in the previous version (see Appendix A of GB/T 18375.8-2004) have been deleted.

This document is modified to adopt ISO 10328:2016 "Structural inspection requirements and test methods for prosthetic lower limbs".

The technical differences between this document and ISO 10328:2016 and the reasons are as follows.

--- Deleted ISO/T R16142.1999 in Chapter 2 Normative References because ISO/T R16142.1999 has been abolished.

The following editorial changes were also made to this document.

---Adjusted the order of the appendix;

--- Supplementary quotations for items listed in Appendix C, Appendix D and Appendix F;

--- Deleted Appendix G.

Introduction

In this document, the term "prosthesis" means an external device used to compensate in whole or in part for the loss or defect of a limb.

The entire international community is very concerned about the safety of prosthetic use, and people also realize that inspection standards will help the development of prosthetics better.

Under the auspices of the International Society of Prosthetics and Orthotics (ISPO), a series of conferences were held. In 1977, a summary meeting was held in Philadelphia, USA.

From 1979 to now, ISO/TC168 has been responsible for the improvement of this series of international standards.

The mechanical properties of the prosthesis during testing may not be consistent with those during actual use.

In actual use, the user applies various loads to the prosthesis for different periods of time. The test methods defined in this document include this includes static strength tests and dynamic strength tests, usually using a single test force to produce a composite test load.

The static strength test corresponds to the worst loading conditions that occur during various activities. The dynamic strength test corresponds to the load during normal walking.

This document specifies fatigue tests on structural components. The data provided by this test are not sufficient to predict the performance of prostheses.

Actual service life.

Evaluation of lower limb prostheses and their components requires clinical trials in addition to laboratory testing as described in this document.

When the load-bearing part of the prosthesis has significant changes in design, laboratory tests and clinical trials should be conducted again.

In theory, additional laboratory test evaluation processes should consider the following factors. function, wear durability and tear resistance, development of new materials, There is no standard for the impact of these factors, so it needs to be supplemented continuously.

Structural inspection of prosthetic lower limbs Requirements and test methods

1 Scope

Important note. This document is applicable to assess whether lower limb prosthetic devices (structures) comply with 4.4 (see Note 1) of GB/T 30659-2014.

The prosthetic ankle-foot devices and foot components on the market have been proven to comply with GB/T 30659-the strength requirements specified in 4.4 of ISO 22675:2014 do not need to be re-tested in accordance with ISO 22675:2016.

WARNING. This document is not intended as a guide for selecting a prosthetic device (structure) for individual lower limb prosthetic prescriptions. Ignoring this warning may result in Safety hazards for amputees.

This document specifies procedures for static and dynamic strength testing (see Note 2) of lower limb prostheses, usually using a single test force to produce a composite test force.

The peak values of the individual force components associated with the composite load on the test specimen usually occur at different moments during the stance phase of walking.

The tests described in this document include.

--- Static and dynamic tests of the main structure of all components;

--- Substructure torsion static test of all components;

--- Static and dynamic testing of ankle-foot devices and foot components, including the entire ankle-foot device as a whole Individual components, or the ankle connector and the entire foot assembly as a single component, are tested statically and dynamically;

--- For the knee joint and all its connecting parts or the knee-tibia component and its adjacent components are subjected to sub-structural static ultimate strength tests;

--- Perform static and dynamic tests on the knee locking substructures of all mechanical devices that lock the knee joint or knee-tibial component in the extended position.

The tests described in this document apply to certain types of ankle disarticulation prostheses (see Note 2), transtibial (below the knee) prostheses, knee disarticulation prostheses, Leg (above-knee) prostheses, and distal (lower) components of hip disarticulation and hemi-pelvic prostheses (see Note 3).

NOTE 1 These tests can be applied to complete structures, parts of structures or individual components.

NOTE 2 These tests apply only to ankle amputee prostheses that incorporate ankle-foot unit components from a common production line.

NOTE 3 The distal component includes the knee and ankle-foot assembly and all intermediate components. ISO 15032 describes the test methods for hip joint components.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document. For referenced documents without a date, the latest version (including all amendments) applies to this document.

GB/T 14191.1-2009 Prosthetics and orthotics terminology Part 1: Basic terms for external limb prostheses and external orthoses (ISO 8549-1:1989, IDT) GB/T 30659-2014 Prostheses and orthoses Requirements and test methods (ISO 22523:2006, IDT) ISO 22675:2016 Prosthetics - Testing of prosthetic ankle-foot devices and foot components - Requirements and test methods Note. GB/T 31181-2014 Prosthetic ankle-foot devices and foot components Requirements and test methods (ISO 22675:2006, IDT)

3 Terms and definitions

The terms and definitions defined in GB/T 14191.1-2009 and the following apply to this document.