STEP Lab specializes in the design and production of advanced biomedical testing systems tailored to evaluate medical devices in compliance with international standards. Among these, ISO 10328 plays a crucial role in certifying the structural safety and durability of lower limb prosthetic components.
What is ISO 10328?
ISO 10328 is an international standard developed by the International Organization for Standardization to assess the structural integrity of lower limb prostheses. It specifies testing methods and loading conditions to ensure prosthetic devices meet strength and fatigue resistance requirements as defined in ISO 22523.
Importantly, ankle-foot devices and foot units that comply with ISO 10328 are not required to undergo separate strength testing under ISO 22675, simplifying the certification process for manufacturers.
What Does ISO 10328 Measure?
ISO 10328 measures both static and cyclic performance of prosthetic components. The objective is to replicate the mechanical stresses experienced during walking, particularly the stance phase, where peak loads are applied to the limb.
The standard includes:
- Static tests, which apply a single, gradually increasing force.
- Cyclic fatigue tests, which simulate repetitive walking loads (up to 3 million cycles) to validate long-term durability.
Why is ISO 10328 Important?
Compliance with ISO 10328 ensures that prosthetic devices are not only mechanically safe but also reliable over time. This is critical for user safety and quality of life, as lower limb prostheses are subject to intense daily use. For manufacturers, meeting ISO 10328 means their products are market-ready and aligned with international safety and performance regulations.
ISO 10328 – Testing Procedures
The testing procedures defined by ISO 10328 simulate real-life loading conditions by applying compound forces to the prosthetic components. These procedures are designed to assess the mechanical behavior under worst-case loading scenarios and include:
- Positioning the prosthesis to simulate realistic gait angles
- Applying specific force levels according to the component type
- Conducting millions of cycles for fatigue validation
ISO 10328 – Different Tests
ISO 10328 includes a wide range of test configurations, each targeting specific components and failure modes:
- Principal static and cyclic tests for all prosthetic components
- Static torsion tests to assess rotational strength
- Separate static and cyclic tests for ankle-foot devices and foot units
- Ultimate strength test at maximum knee flexion for knee joints
- Static and cyclic tests on knee locks, for mechanisms that lock the knee in extension
ISO 10328 – Types of Prostheses
The standard is applicable to several prosthetic designs and amputation levels, including:
- Ankle-disarticulation prostheses
- Transtibial (below-knee) prostheses
- Knee-disarticulation prostheses
- Transfemoral (above-knee) prostheses
- Distal components of hip-disarticulation and hemi-pelvectomy prostheses
This wide applicability makes ISO 10328 a reference standard across the prosthetics industry.
TESTING MACHINES FOR ISO 10328
To meet the requirements of ISO 10328, STEP Lab recommends its EA Series (electromechanical testing machine), engineered for both static and dynamic testing of biomedical devices. Our is a versatile solution for conducting tests that require high accuracy and speed in both force and position control.
- Dynamic loads range up to 200kN
- Zero maintenance and easy installation
- Low energy consuming
- Highly reliable test
Explore our catalog or contact us to find the right product for your business together.
