ISO 10328:2016

Overview

ISO 10328:2016 - "Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods" specifies standardized procedures for the structural testing of lower‑limb prosthetic components. It defines how to perform static and cyclic strength tests that reproduce compound loadings representative of peak forces during the stance phase of gait. ISO 10328:2016 is intended for conformity assessment against the strength requirements in Clause 4.4 of ISO 22523:2006.
Warning: ISO 10328:2016 is not a clinical selection guide for prescribing a specific prosthesis and must not be used as such.

Key Topics and Technical Requirements

• Static and cyclic strength tests: Procedures to assess ultimate and fatigue performance under combined load conditions produced by a single test force.
• Test forces and moments: Designations, symbols, and definitions of the forces and moments applied during principal and separate tests.
• Coordinate systems and reference planes: Standardized axes, top/knee/ankle/bottom planes, effective joint centres and centrelines used to align and load test samples.
• Test loading conditions and levels: Defined loading scenarios, test load values, dimensions and cycle counts for reproducible testing.
• Test samples and alignment: Guidance on selecting complete or partial structures, worst‑case alignments, preparation, identification and multiple‑use restrictions.
• Equipment and accuracy: Requirements for end attachments, jigs, test machines and measurement accuracy to ensure valid results.
• Compliance and documentation: Criteria for claiming conformity, number of samples/tests, and required submission documents for test laboratories.
• Special tests: Separate procedures for ankle‑foot devices, foot units, torsion tests, knee joints (including max flexion ultimate strength) and knee locks.

Applications and Users

ISO 10328:2016 is applicable for:

• Manufacturers of lower‑limb prostheses and ankle‑foot modules for design verification and type testing.
• Independent test laboratories performing structural strength and fatigue testing.
• Regulatory bodies and certification agencies assessing conformity for market access.
• R&D teams and quality managers validating materials, component interfaces and new designs.
• Prosthetics engineers and product developers using standardized test data to compare designs or to support claims.

Practical uses include product development validation, fatigue life estimation, production quality checks and regulatory submission support.

Related Standards

• ISO 22523:2006 - Strength requirements referenced by ISO 10328:2016.
• ISO 22675:2016 - Note that ankle‑foot devices previously tested under ISO 10328:2006 might not require retesting to ISO 22675:2016 if they already demonstrated compliance.

Keywords: ISO 10328:2016, prosthetics structural testing, lower‑limb prostheses, static and cyclic strength tests, ankle‑foot devices, conformity assessment.