ISO 10328-2016 PDF

Full title and description

ISO 10328:2016 — Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods. This international standard specifies procedures, test configurations and load levels for static and cyclic (fatigue) structural testing of lower‑limb prosthetic components and assemblies to assess their mechanical strength and durability.

Abstract

ISO 10328:2016 (Edition 2) defines standardized static and cyclic strength tests that produce compound loadings representative of peak loads occurring during the stance phase of walking. The tests cover complete prostheses and many individual components (including ankle‑foot assemblies, knee units and connectors), and include additional torsion, knee‑flexion and knee‑lock tests where applicable. The standard is intended for conformity assessment of structural strength and related performance; it is not a clinical selection guide for prescribing a specific prosthesis for an individual user.

General information

• Status: Published
• Publication date: June 2016 (Edition 2, 2016)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics)
• Edition / version: Edition 2 (2016)
• Number of pages: 140

Scope

This International Standard specifies procedures for static and cyclic strength tests on specific types of lower‑limb prostheses and their components. It applies to ankle‑disarticulation prostheses, transtibial (below‑knee), knee‑disarticulation and transfemoral (above‑knee) prostheses and to the distal (lower) part of hip‑disarticulation and hemipelvectomy prostheses. The scope covers test configurations, designation of test forces and moments, coordinate systems, test loading conditions and levels, sample preparation, test equipment and acceptance criteria needed to assess structural strength and durability.

Key topics and requirements

• Definitions, symbols and coordinate systems for test set‑up.
• Designation of static and cyclic test forces and moments representative of gait peak loads.
• Specified test configurations for complete prostheses and individual components (ankle‑foot, knee units, connectors, foot units).
• Static strength tests (ultimate/static limit load) and cyclic (fatigue) tests with defined load cycles and numbers of cycles.
• Additional tests: static torsion, static limit strength at maximum knee flexion, tests of knee‑lock mechanisms, and specific tests for ankle‑foot components and foot units.
• Requirements for test samples, instrumentation, accuracy, reporting and test submission documentation.
• Compliance/acceptance criteria and responsibilities for test preparation and execution.

Typical use and users

Manufacturers of lower‑limb prosthetic components and complete prostheses use ISO 10328:2016 to demonstrate structural strength and durability during product development and for type testing. Independent test laboratories perform the standardized tests for certification and quality control. Regulatory authorities, procurement bodies and conformity assessment organizations reference the standard when evaluating mechanical safety. Researchers, prosthetic design engineers and advanced clinical prosthetists may also use it for comparative testing and product evaluation.

Related standards

Standards commonly referenced alongside ISO 10328:2016 include ISO 22523 (external limb prostheses — requirements and test methods), ISO 22675 (testing of ankle‑foot devices and foot units), ISO/TR 16142 (guidance on selection of standards for medical devices) and the previous edition ISO 10328:2006. Regional/adopted versions (for example BS EN ISO 10328) align national practice with the ISO requirements.

Keywords

ISO 10328, prosthetics, lower‑limb prosthesis, structural testing, static test, cyclic test, fatigue, ankle‑foot, knee unit, strength requirements, test methods, conformity assessment

FAQ

Q: What is this standard?

A: ISO 10328:2016 is an international standard that specifies requirements and test methods for structural (mechanical) testing of lower‑limb prostheses and many of their component parts to assess strength and durability.

Q: What does it cover?

A: It covers static and cyclic strength tests, test configurations, designation of forces and moments, test levels and cycles, additional torsion and knee tests, sample preparation, equipment, accuracy and reporting needed for structural conformity assessment.

Q: Who typically uses it?

A: Manufacturers, independent test laboratories, conformity assessment bodies, regulators, researchers, prosthetic designers and advanced clinicians involved in device evaluation and quality assurance.

Q: Is it current or superseded?

A: ISO 10328:2016 is the second edition (2016) and supersedes the 2006 edition. For the very latest status or any subsequent revisions after 2016, consult the ISO catalogue or your national standards body to confirm whether a newer edition or amendment exists.

Q: Is it part of a series?

A: It is part of the family of prosthetics and orthotics standards maintained by ISO/TC 168. Related documents address device‑specific tests (for example ISO 22675 for ankle‑foot devices) and broader prosthetic requirements (for example ISO 22523).

Q: What are the key keywords?

A: Prosthetics; lower‑limb; structural testing; static strength; fatigue (cyclic) testing; ankle‑foot; knee unit; conformity assessment; ISO 10328