ISO 13404:2007

Overview

ISO 13404:2007 - "Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components" establishes a standardized method to classify and describe external orthoses and the components from which they are assembled. The standard enables clear, consistent descriptions of finished orthoses and component parts without referencing manufacturers’ trade names, materials or proprietary processes.

Key topics and requirements

• Scope and purpose: Provides a systematic framework for describing orthoses by the body segments and joints they encompass (using terms from ISO 8549‑3).
• Function classification: Defines principal orthotic functions such as:
  • managing deformity (prevent, reduce, hold),
  • changing joint range of motion (limit or increase),
  • changing limb dimensions (length or shape),
  • managing neuromuscular function (compensate or control),
  • redistributing tissue load.
• Type of fabrication: Differentiates custom fabricated and prefabricated orthoses.
• Component classes: Requires specification of four component classes:
  • Interface components (shells, pads, straps, foot orthoses, shoes) - components in direct contact with the user;
  • Articulating components (joints for spinal, hip, knee, ankle, wrist, etc.) - permissible motions, form of articulation (movement vs deformation), axis type (monocentric vs polycentric), and controls (locks, motion limits, assist/resist features);
  • Structural components (uprights, shells) - location, relation to anatomical segments, adjustability;
  • Cosmetic components (fillers, covers/sleeves).
• Descriptive requirements: For each orthosis and component, state the anatomical segments/joints, permitted motions, axes of rotation, control mechanisms (including activation methods and adjustment), and any dimensional/functional specifications needed for clinical clarity.

Applications and practical value

• Enables uniform product descriptions in manufacturer literature and catalogs.
• Supports clinical prescription and documentation by giving practitioners a precise vocabulary for orthosis selection and goals of treatment.
• Helps researchers and auditors report and compare orthotic interventions across studies and patient groups.
• Assists regulatory, procurement and insurance stakeholders in classifying devices and verifying functionality without reliance on brand names.
• Useful for orthotic design teams to specify component interactions and controls during development.

Who should use this standard

• Orthotists and prosthetists, rehabilitation clinicians, product designers, manufacturers, researchers, healthcare administrators, and regulators involved in orthotic device specification, documentation, reporting and procurement.

Related standards

• ISO 8549‑1 - Vocabulary: general terms for external limb prostheses and orthoses
• ISO 8549‑3 - Vocabulary: terms relating to external orthoses
• ISO 8551 - Functional deficiencies and clinical objectives for orthoses

Keywords: ISO 13404:2007, orthoses classification, orthotic components, prosthetics and orthotics, interface components, articulating components, structural components, cosmetic components, orthosis description.