ISO 21064:2017

• Abstract:

  ISO 21064:2017 establishes a method of classifying and describing the devices that are used in the field of foot orthotics. It does not describe the materials or manufacturing methods used for their fabrication.

• Status: Published
• Publication Date: 19-Jul-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 168 - Prosthetics and orthotics
• Drafting Committee: ISO/TC 168/WG 1 - Nomenclature and classification
• Current Stage: 9092 - International Standard to be revised
• Start Date: 16-Jun-2025
• Completion Date: 12-Sep-2026

Overview - ISO 21064:2017 (Foot orthotics classification)

ISO 21064:2017, titled Prosthetics and orthotics - Foot orthotics - Uses, functions classification and description, defines a standardized method to classify and describe devices applied to the foot (foot orthoses), medical shoes and shoe adaptations. The standard clarifies clinical uses, functions and components of foot orthotics without prescribing materials or manufacturing methods. It was developed by ISO/TC 168 (Prosthetics and orthotics).

Key topics and requirements

• Scope and terminology
  • Establishes clear definitions for foot orthoses, medical shoes (custom-made and off‑the‑shelf) and shoe adaptations.
• Clinical uses (indications)
  • Lists clinical objectives such as: pain relief, improved balance and gait, treatment of reducible or irreducible deformities, joint instability control, limb‑length compensation, tissue protection, wound healing, and sensorimotor stimulation.
• Functional descriptions
  • Describes device functions: reduce/correct deformities, contain permanent deformities, control alignment/movement of joints, redistribute or reduce load, and apply focused pressure when clinically required.
• Classification framework
  • Three main classes: foot orthoses, medical shoes, and adaptations (modifications) of shoes.
• Device types and elements
  • Enumerates orthosis elements (e.g., heel lifts, heel pads, arch supports, metatarsal supports, wedges, supramalleolar extensions, toe protectors, local pressure‑relief systems).
  • Describes medical shoes features (extra width/depth, protective toe caps, reinforced soles, cradle soles, easy closures) and when custom‑made vs series products are appropriate.
• Non‑prescriptive
  • Explicitly does not define materials or manufacturing processes - focus is classification, clinical objectives and descriptive language.

Applications and practical value

• Standardizes clinical documentation and product descriptions for foot orthotics, improving communication between:
  • Clinicians and prescribers (orthotists, podiatrists, physiatrists)
  • Manufacturers and suppliers (product cataloguing, technical data)
  • Researchers and educators (consistent terminology for studies and training)
  • Regulatory and procurement teams (specifying device categories and intended functions)
• Useful for creating treatment reports, device labeling, procurement specifications, clinical protocols and multidisciplinary care plans.

Who uses ISO 21064:2017

• Orthotists and prosthetists, podiatrists, rehabilitation specialists, medical shoemakers, product designers, clinical researchers, standards writers and hospital procurement/regulatory staff.

Related standards

• ISO 8549-3 (Vocabulary: terms related to external orthoses) is referenced for terminology.
• Definitions and term lookups available via the ISO Online Browsing Platform (OBP).

Keywords: ISO 21064, foot orthotics, foot orthoses classification, medical shoes, shoe adaptations, prosthetics and orthotics, orthoses functions, clinical uses.