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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 41178-2021: Prosthetics and orthotics - Soft orthoses - Uses, functions, classification and description Status: Valid
Basic dataStandard ID: GB/T 41178-2021 (GB/T41178-2021)Description (Translated English): Prosthetics and orthotics - Soft orthoses - Uses, functions, classification and description Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C45 Word Count Estimation: 7,781 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 41178-2021: Prosthetics and orthotics - Soft orthoses - Uses, functions, classification and description---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. Prosthetics and orthotics -- Soft orthoses -- Uses, functions, classification and description ICS 11:040:40 CCSC45 National Standards of People's Republic of China Prosthetics and OrthoticsSoft Orthotics Purpose, Function, Classification and Description (ISO 21063:2017, IDT) Published on 2021-12-31 2021-12-31 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Use 1 5 Function 2 6 Category 2 7 Description 2 7:1 Type of manufacture 2 7:2 Types of Orthotic Components 3 7:3 Description of the orthosis components 3 forewordThis 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" drafted: This document is equivalent to ISO 21063:2017 "Use, function, classification and description of soft orthoses for prostheses and orthoses": Please note that some content of this document may be patented: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the Ministry of Civil Affairs of the People's Republic of China: This document is under the jurisdiction of the National Technical Committee on Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148): This document was drafted by: National Research Center for Rehabilitation Aids, Hefei Jingtong Rehabilitation Equipment Co:, Ltd:, Anhui Senai Chi Hospital Management Co:, Ltd: Co:, Ltd:, Tongling Huiren Rehabilitation Hospital, Xi'an Nanxiaofeng Spine Orthopedics Studio: The main drafters of this document: Tao Jing, Zhang Zhiqiang, Zhao Liwei, Ma Fengling, Yang Dehui, Yun Xiao, Nan Xiaofeng, Xie Hua, Li Jingtong, Fang Liye, Ge Hui:IntroductionThere is currently no internationally recognized method for external applicators made of flexible materials that apply pressure to the body part they enclose: law to describe it: In some areas, these devices are called "bandages": This is the case for medical practitioners to prescribe such orthoses, manufacturers to describe their products, and to mention in patient treatment and efficacy reports: And this kind of equipment caused trouble: This document uses the term "soft orthosis" for this type of appliance: Prosthetics and OrthoticsSoft Orthotics Purpose, Function, Classification and Description1 ScopeThis document gives the purpose and function of soft orthoses and classifies and describes such orthoses and their components: Materials or manufacturing processes are not described in this document:2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document: ISO 8549-1 Terminology for prosthetics and orthotics - Part 1: Basic terminology for external limb prostheses and external orthoses (Prostheticsandorthotics-Vocabulary-Part 1:Generaltermsforexternallimbprothesesandex- ternalorthoses) Note: GB/T 14191:1-2009 Terminology of prosthetics and orthotics - Part 1: Basic terms for external limb prostheses and external orthoses (ISO 8549- 1:1989, IDT) ISO 8549-3 Prosthetics and Orthotics Terminology Part 3: Orthotic Terminology (Prosthetics and orthotics-Vo- cabulary-Part 3:Termsrelatingtoexternalorthoses) ISO 8551 Prosthetics and orthosesDescription of patients treated with orthoses, clinical treatment goals, functional requirements for orthoses (Prostheticsandorthotics-Functionaldeficiencies-Descriptionofthepersontobetreatedwithan orthosis, clinical objective of treatment, and functional requirements of the orthosis) ISO 13404 Prosthetics and orthotics Classification and description of orthoses and orthotic components (Prosthetics and orthotics-Cate- gorizationanddescriptionofexternalorthosesandorthoticcomponents)3 Terms and DefinitionsTerms and definitions defined in ISO 8549-1, ISO 8549-3, ISO 8551 and ISO 13404 and the following terms and definitions apply to this document: 3:1 softorthoses An orthosis made by applying pressure circumferentially from a soft surface material: If desired, it can be wrapped by using pads and/or inserts Apply localized pressure to the surface of the wrapped body part: NOTE: They may contain orthotic joints and/or other components used to control joint movement and/or alignment: Does not include tape, stockings, and burns pressure clothing:4 PurposeSoft orthoses can achieve the following clinical purposes: a) stimulate motor sensory feedback; 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