What is ISO 10328?
ISO 10328 is the standard for structural testing of lower-limb prostheses. It describes how to load a prosthetic component in a test machine, with which forces, and how many cycles it must survive. Typical parts that require an ISO 10328 test are prosthetic knee joints, ankle-foot units, feet, pylons, adapters and socket connectors. More and more, also 3D printed sockets are tested in line with ISO10328.
Which loading level do you test to?
The standard has loading levels from P3 (60kg) to P8 (175kg). A higher level means a heavier user and higher forces. The most common levels are P5 (100kg) and P6 (125kg). You choose the level for which you want to declare your product.
Which tests are required?
The main tests are a cyclic (also called dynamic) test, followed by a static proof test and a separate static ultimate strength test. These apply for all components. Most components also need a static torsion test.
For prosthetic knees, there is the maximum knee flexion test, and for knees that also have a knee lock system, there is the knee lock test.
Prosthetic feet have a different procedure for the dynamic and static testing, and cannot be tested on a universal testing machine. They can also be tested using the ISO 22675 norm for testing prosthetic feet.
How many samples do you need?
Each product is tested in two conditions, the condition I (heel load) and the condition II (toe load). For each of these conditions, two samples have to pass the dynamic and static tests. So you normally need at least 4 samples. You can reuse samples that have gone through one of the tests successfully, and use them for a next test. And if they fail in that next test, you can try again with a new sample. So in some cases, less than 4 samples is possible, but it is better to have sufficient samples at the start, so that if a sample fails, you can quickly continue the test with a new sample.
For a formal ISO10328 test, that is part of your product release process and will be documented in the technical file, you need samples for the initial production series. You cannot use R&D samples for the final release test.
Can I do the tests myself?
Yes. For Class I products, the testing and release process will can be a normal part of your quality management system. So you can do all the tests in-house on your own testing machine, document them in a test report that fullfills the requirement of ISO10328, and add them to the technical file. Nowadays with the help of of AI, it is not difficult to prepare a test procedure, a test order form and a test report that fullfill all the requirements of ISO10328. The tricky part is to setup samples correctly according to the norm. Our ISO10328QuickAlign testing lever system is aimed at making this a quick process which largely prevents possible errors.
How long does it take?
Each cyclic test lasts 3 million cycles. At 1Hz this takes 35 days, at 3 Hz or 5 Hz, it takes 12 or 7 days. Our Mover7 testing machine can reach 5Hz for most samples, the faster Mover5 testing machine can even reach 10Hz for stiffer samples, like prosthetic adapters, which reduces the duration of one test to 3.5 days. Parallel testing is an efficient way to reduce the test duration, so having access to more than one testing machine can improve your efficiency.
What does it cost?
This depends.
If you test several samples per year, having your own testing machine quickly becomes the most affordable option.
For smaller testing quantities, you can either select a certified testing laboratory that give you a certified test report, like Cerah in France or Endolab in Germany.
Or you can use our testing as a service program. We are not a certified testing laboratory, so we will provide you with all the test resulst, which you can integrate in your technical file.
Test in your own lab
Having your own in-house testing capacity is the best solution for any R&D setting that develops products on a regular basis and for any company that wants to use testing as a regular part of their quality control process. Our Mover Testing machines are developed solely for the orthopedic industry and allow you to drastically speed up your R&D process at surprisingly affordable cost.
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Let us test for you
If you have a limited number of samples, or you want a first impression of the durability of your design, send us your samples. We agree on a test plan with the duration and the expected cost. After the test you get a report with the data and photos.