ISO 13404-1:2024

Overview

ISO 13404-1:2024 - Prosthetics and orthotics - External orthoses and orthotic components - Part 1: Uses, functions, classification and description of lower limb orthoses - provides a standardized framework for describing external lower limb orthoses and their components. The standard specifies intended uses, functional capabilities, classification criteria and descriptive elements for finished orthoses and constituent parts, enabling consistent documentation, clinical communication and product labelling. It does not prescribe materials or manufacturing methods.

Key topics and technical requirements

• Scope and definitions: Clear terminology for types of orthoses (prefabricated, adaptable, user‑matched, custom‑made), and functional categories such as static, dynamic, adjustable and automatically controlled orthoses.
• Uses: Systematic list of clinical objectives an orthosis may serve, including pain relief, protection, edema control, deformity management, muscle assistance, sensory‑motor feedback and mobility support (standing, transfers, ambulation).
• Functions: How an orthosis achieves its uses - e.g., holding alignment, limiting or increasing joint range of motion, assisting or resisting muscle actions, mechanical coupling for gait, and load redistribution on tissues.
• Classification and description: Rules for classifying both whole devices and components by method of fabrication, type, structural/interface components, orthotic joints (motions, modes, axis of rotation, control/activation), functional electrical stimulators and finishing components.
• Component detail: Guidance on describing structural components, interface elements and orthotic joints, including modern aspects such as control and activation of components (reflecting development of powered/automatic systems).
• Limitations: Explicit statement that materials and manufacturing processes are outside the document’s remit - descriptions should focus on principal characteristics and intended function.

Applications and users

Who benefits from ISO 13404-1:2024:

• Clinicians and prescribing practitioners - to document clinical objectives, specify orthosis types and ensure consistent communication with fabrication teams.
• Manufacturers and product managers - to describe products consistently in datasheets, regulatory submissions and technical documentation.
• Researchers and evaluators - to classify devices and compare outcomes across studies using standardized device descriptions.
• Regulatory and procurement professionals - to interpret device claims and align product specifications with clinical needs.

Practical applications:

• Writing consistent product specifications and labelling for lower limb orthoses.
• Creating clinical prescriptions and reports that clearly state intended uses and functional requirements.
• Standardizing component inventories and modular orthosis descriptions for clinics and suppliers.

Related standards

• ISO 21063 - Soft orthoses (lower limb)
• ISO 21064 - Foot orthotics
• ISO 8549‑1 / ISO 8549‑3 - Vocabulary for prosthetics and orthotics
• ISO 8551 - Functional deficiencies and orthosis functional requirements

Keywords: ISO 13404-1:2024, lower limb orthoses, prosthetics and orthotics, orthotic components, classification, uses, functions, external orthoses.