ISO 21063:2017

Overview

ISO 21063:2017 - "Prosthetics and orthotics - Soft orthoses - Uses, functions, classification and description" provides a standardized framework for describing soft orthoses (soft braces and supports) used in prosthetics and orthotics. The standard defines the uses and clinical functions, classifies devices by body segment, and specifies how to describe device types and components. It does not prescribe materials, manufacturing methods or specific product design requirements.

Key Topics

• Scope and terminology
  • Establishes the term soft orthoses for devices that apply circumferential and/or local pressure to body segments.
  • References established vocabularies (see Related Standards).
• Uses (clinical objectives)
  • Stimulate sensorimotor responses
  • Reduce or prevent oedema
  • Control movement and/or alignment of one or more joints
  • Reduce pain, promote healing, and protect tissues
• Functions
  • Apply continuous circumferential pressure
  • Apply local pressure via pads/inserts
  • Control movement and alignment
• Classification
  • Classifies devices by the anatomical segment or joint they serve, using standard abbreviations (examples include FO - foot orthosis, AFO - ankle-foot orthosis, KO - knee orthosis, WHO - wrist-hand orthosis, TLSO - thoraco-lumbo-sacral orthosis).
• Device description requirements
  • Indicate fabrication type: custom-made or off-the-shelf/series (with note if series devices require adjustment).
  • Describe orthotic elements: junction elements (soft materials; elastic, non‑elastic or mixed; circumferential and/or longitudinal action) and orthotic joints (which joints are controlled).
  • Document modifications that change pressure distribution (pads, inserts, bands).

Applications

ISO 21063:2017 is practical for:

• Clinicians and prescribers documenting orthotic goals and specifying device type and function in treatment plans.
• Orthotists and technical fitters for consistent device description, communication, and clinical reporting.
• Manufacturers and product managers when preparing product descriptions, labeling and technical documentation (without prescribing materials).
• Researchers, payers and regulators who need consistent classification for studies, reimbursement coding and regulatory submissions.

Using ISO 21063 improves clarity in clinical communication, device selection, outcome reporting and cross‑border comparability of soft orthoses.

Related Standards

• ISO 8549-1 - Prosthetics and orthotics - Vocabulary, Part 1
• ISO 8549-3 - Vocabulary, Terms for external orthoses
• ISO 8551 - Description of user condition, clinical objectives and functional requirements
• ISO 13404 - Classification and description of external orthoses and components

Keywords: ISO 21063:2017, soft orthoses, prosthetics and orthotics, classification and description, uses and functions, orthotic devices, soft braces.