ISO 13405-3:2015

Overview

ISO 13405-3:2015 - Prosthetics and orthotics - Classification and description of prosthetic components - Part 3: Description of upper limb prosthetic components - specifies a standardized method for describing components used in upper‑limb prostheses. The document provides a systematic vocabulary and classification approach so manufacturers, clinicians and service providers can describe sockets, suspensory systems, functional joints and finishing components in a consistent, unambiguous way.

Key topics and technical requirements

• Scope and normative references: Connects to ISO 13405‑1 (classification) and ISO 8549‑4 (amputation vocabulary) to ensure consistent terminology.
• Classification tree: Components are grouped into five classes - Interface, Functional, Alignment, Structural, and Finishing (cosmetic) - with a classification tree for upper limb prosthetic components.
• Interface components (sockets & suspension):
  • Sockets: Require description of intended level of amputation (partial hand through scapulo‑thoracic), force‑transmission properties (axial vs distal vs total socket stabilization), transverse stabilization (anteroposterior, mediolateral, rotational), area of contact, stiffness, and activation/control features.
  • Suspensory components: Classification by type and suspension sites.
• Functional components:
  • Definition of permissible motions and standardized descriptions of terminal devices (types, activation, control, special features).
  • Detailed descriptors for wrist, elbow, shoulder units, external (side) joints, humeral rotation units, and any additional flexion units (motions, activation and control methods).
• Alignment, Structural and Finishing components: Requirements for describing alignment adjustment features, load‑bearing structural parts, and cosmetic finishes.

Practical applications and users

• Manufacturers and product documentation: Use ISO 13405‑3 to produce clear, comparable product literature that describes component characteristics and intended amputation levels.
• Clinicians and prosthetists: Standardized descriptions aid component selection, reporting, and interdisciplinary communication in prosthetic fitting and rehabilitation.
• Regulatory bodies and procurement: Facilitates specification, tendering and regulatory review by providing consistent component descriptors.
• Researchers and educators: Provides a common language for publication, comparison and training in upper‑limb prosthetics.

Related standards and revision notes

• Part of the ISO 13405 series (see ISO 13405‑1 and ISO 13405‑2). This 2015 second edition expands the classification tree, extends amputation levels (including partial hand), and updates socket suspension and functional component types to reflect technological advances.

Keywords: ISO 13405‑3, upper limb prosthetic components, prosthetics and orthotics, socket classification, terminal devices, wrist unit, elbow unit, shoulder unit, amputation levels, prosthetic component description.