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GBZ40839-2021: Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components
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| GB/Z 40839-2021 | English | 184 |
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Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components
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GB/Z 40839-2021
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Basic data | Standard ID | GB/Z 40839-2021 (GB/Z40839-2021) | | Description (Translated English) | Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components | | Sector / Industry | National Standard | | Classification of Chinese Standard | C45 | | Word Count Estimation | 10,192 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GBZ40839-2021: Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
GB /Z 40839-2021
Prosthetics and orthotics - Categorization and description of external orthoses and orthotic components
ICS 11.040.40
CCSC45
National Standardization Guiding Technical Documents of the People's Republic of China
Prosthetics and orthotics
Classification and description of orthotics and orthotic components
(ISO 13404.2007, IDT)
Released on 2021-10-11
2021-10-11 implementation
State Administration of Market Supervision and Administration
Issued by the National Standardization Management Committee
Table of contents
Foreword Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Classification of orthotics 1
4.1 Overview 1
4.2 Function 2
4.3 Production Type 3
5 Classification of orthopedic components 3
5.1 General 3
5.2 Parts in contact with human body 3
5.3 Joint parts 4
5.4 Structural parts 5
5.5 Decorative parts 6
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)
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents.
This document was proposed by the Ministry of Civil Affairs of the People's Republic of China.
This document is under the jurisdiction of the National Standardization Technical Committee for Rehabilitation and Special Equipment for the Disabled (SAC/TC148).
Drafting organizations of this document. National Rehabilitation Assistive Devices Research Center, National Rehabilitation Assistive Devices Quality Supervision and Inspection Center, Beijing Global Jingbo Rehabilitation Assistant
Technology Co., Ltd.
The main drafters of this document. Gu Huiru, Song Liang, Yan Heping, Li Guiling.
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
4.1 Overview
By using the terms defined in ISO 8549-3 and shown in Table 1, the orthosis is described with reference to body parts and joints.
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