Overview
ISO 13405-2:2015 - Prosthetics and orthotics - Classification and description of prosthetic components - Part 2: Description of lower limb prosthetic components - specifies a standardized method for describing lower limb prosthetic components. The second edition (2015) revises and expands the original 1996 document to reflect advances in prosthetic technology and to provide a systematic vocabulary and classification for components used in lower-limb prostheses.
Key topics
- Component classes: Describes five classes of components (Interface, Functional, Alignment, Structural, Finishing/cosmetic) as defined in ISO 13405-1.
- Interface components (sockets & suspension):
- Levels of amputation covered (partial foot through trans‑pelvic).
- Force-transmission properties: axial and transverse stabilization, suspension methods, and stiffness considerations.
- Guidance on describing sockets and use with liners.
- Functional components:
- Ankle‑foot units (jointed and unjointed), motions, activation/control, and special features.
- Knee units: motions, axis of rotation, activation/control, and swing–stance transition.
- Hip units, external (side) joints, axial rotators (torque reducers), load attenuators (shock absorbers), and turntables.
- Alignment components: types and ranges of adjustment for prosthetic alignment.
- Structural and finishing components: requirements for mechanical and cosmetic elements of a finished prosthesis.
- Emphasis on clear, non‑proprietary descriptions (avoids trade names and specific manufacturing methods).
Applications
- Standardizes product literature and technical datasheets so manufacturers describe lower‑limb prosthetic components consistently.
- Supports clinicians and prosthetists when documenting components used in patient treatment and when communicating component characteristics across teams.
- Useful for procurement, interoperability, regulatory submissions, clinical research, and comparative evaluation of prosthetic components.
- Helps ensure clarity in specifications for custom fabrication, component selection, and patient records.
Who uses it
- Prosthetists and orthotists
- Prosthetic component manufacturers
- Clinical teams, rehabilitation specialists, and researchers
- Medical device regulators and procurement officers
Related standards
- ISO 13405‑1:2014 - Classification of prosthetic components
- ISO 8549 series (vocabulary for prosthetics and orthotics): Parts 1, 2 and 4 referenced by ISO 13405‑2
Keywords: ISO 13405-2:2015, lower limb prosthetic components, prosthetics and orthotics, socket description, ankle-foot units, knee units, hip units, prosthetic alignment, component classification.
Open preview (PDF)Prosthetics and orthotics — Classification and description of prosthetic components — Part 2: Description of lower limb prosthetic components