GB/Z 40839-2021Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"

Drafting.

This document uses the translation method equivalent to the ISO 13404.2007 "Classification and description of prostheses and orthotics, orthotics and orthotic components"

Narration.

The Chinese documents that have consistent correspondence with the normatively cited international documents in this document are as follows.

---GB/T 14191.1 Terms of prosthetics and orthotics-Part 1.Basic terms of external limb prostheses and external orthoses

(GB/T 14191.1-2009, ISO 8549-1.1989, IDT)

Introduction

There is no internationally recognized classification and description method for external orthotics and their components currently in use. This situation gives orthopedic assemblers

The assembly process of the manufacturer, the product description process of the manufacturer, and the relevant practitioners of the medical institution in the prescription for the treatment of specific patients

Cheng Du caused difficulties.

This file system classifies and describes the finished orthotics and orthosis components, and at the same time, the assembly application characteristics of the orthosis components

All are clearly explained.

This document does not involve the manufacturer's trademarks, materials and process details.

Prosthetics and orthotics

Classification and description of orthotics and orthotic components

1 Scope

This document gives the classification and description of orthoses and orthotic components.

2 Normative references

The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations

Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to

This document.

ISO 8549-1 Prosthetics and orthotics terminology Part 1.Basic terminology for external limb prostheses and external orthoses (Pros-

theticsandorthotics-Vocabulary-Part 1.Generaltermsforexternallimbprosthesesandexternal

orthoses)

ISO 8549-3 Prosthetics and orthotics terminology Part 3.Basic terminology for external orthoses (Prosthetics and orthotics-

ics-Vocabulary-Part 3.Termsrelatingtoexternalorthoses)

ISO 8551 Functional defects of prostheses and orthotics for people who will be treated with orthotics, clinical treatment goals, and orthosis functions

Required description (Prostheticsandorthotics-Functionaldeficiencies-Descriptionofthepersontobe

treatedwithanorthosis, clinicalobjectivesoftreatment, andfunctionalrequirementsoftheorthosis)

3 Terms and definitions

The following terms and definitions defined by ISO 8549-1, ISO 8549-3 and ISO 8551 apply to this document.

3.1

Custom orthosis customfabricatedorthosis

In order to meet the user's personalized functional requirements, design and manufacture based on its specific information such as mold, sample, size and appearance, etc.

Device.

3.2

Prefabricatedorthosis

In order to meet specific functional requirements, it can be applied within a certain range of orthosis devices.

Note. The selected orthosis can be adjusted according to the user's personal situation.

4 Classification of orthotics