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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 19544-2024: Classification and general technology requirements of spinal orthoses Status: Valid GB/T 19544: Historical versions
Basic dataStandard ID: GB/T 19544-2024 (GB/T19544-2024)Description (Translated English): Classification and general technology requirements of spinal orthoses Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C45 Classification of International Standard: 11.180.01 Word Count Estimation: 22,210 Date of Issue: 2024-04-25 Date of Implementation: 2024-08-01 Older Standard (superseded by this standard): GB/T 19544-2004 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 19544-2024: Classification and general technology requirements of spinal orthoses---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.ICS 11:180:01 CCSC45 National Standards of People's Republic of China Replace GB/T 19544-2004 Classification and general technical requirements of spinal orthoses Released on 2024-04-25 2024-08-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Classification and model 2 4:1 Classification 2 4:2 Model 3 5 Technical Requirements 4 5:1 Appearance Quality 4 5:2 Design and structure 4 5:3 Materials 8 5:4 Size 9 5:5 Adaptability 9 5:6 Strength 10 6 Inspection methods11 6:1 Inspection equipment and tools 11 6:2 Single Item Test Method 11 7 Marking label, instruction manual 12 7:1 Signs and labels 12 7:2 User Manual 12 8 Packaging, transportation and storage 12 8:1 Packaging 12 8:2 Transportation12 8:3 Storage 13ForewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting: This document replaces GB/T 19544-2004 "Classification and general technical requirements for spinal orthoses" and is consistent with GB/T 19544-2004: In addition to structural adjustments and editorial changes, the main technical changes are as follows: --- Changed the terms and definitions (see Chapter 3, Chapter 3 of the:2004 edition); --- Deleted "Spinal orthoses classified by material (see 4:1:1 of the:2004 edition); --- Changed the classification by function (see 4:1:1, 4:1:2 of the:2004 edition); --- Changed the classification by body part, added chest orthosis and thoracolumbar orthosis (see 4:1:2, 4:1:3 of the:2004 edition); --- The model composition has been changed (see 4:2, 4:2 of the:2004 edition); --- Added the design and structural requirements for chest orthosis and thoracolumbar orthosis (see 5:2:5, 5:2:6); --- Changed the material requirements (see 5:3, 5:2:1 of the:2004 edition); --- Changed the fitting requirements (see 5:5, 5:2:4 of the:2004 edition); --- Added "strength" (see 5:6); --- Deleted the requirements of "Inspection Rules" (see Chapter 7 of the:2004 edition); --- Changed the marking requirements (see 7:1, 8:1 of the:2004 edition); --- Added the requirements for "Instructions for Use" (see 7:2); --- Changed the storage requirements (see 8:3, 8:4 of the:2004 edition); --- Deleted the "delivery" requirement (see 8:5 of the:2004 edition): Please note that some of the contents of this document may involve patents: The issuing organization of this document does not assume the responsibility for identifying patents: This document is issued by the Ministry of Civil Affairs of the People's Republic of China: This document is under the jurisdiction of the National Technical Committee for Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148): This document was drafted by: National Rehabilitation Equipment Research Center, Kefu Medical Technology Co:, Ltd:, Xi'an Schroth Health Technology Co:, Ltd: Company, Xiangya Second Hospital of Central South University, Hangzhou Yijia 3D Additive Technology Co:, Ltd:, Yunnan Provincial First People's Hospital, Taiyuan Deao Hospital Limb Orthopedic Rehabilitation Technology Industry Co:, Ltd:, Jinhua Deren Rehabilitation Assistive Equipment Co:, Ltd:, Beijing University of Posts and Telecommunications, and Beijing University of Aeronautics and Astronautics: The main drafters of this document are: Ma Fengling, Ma Lifang, Liu Junling, Tu Chao, Nan Xiaofeng, Huang Youwei, Zhu Xiangzhan, Zhao Liwei, Wang Yun, Mo Zhongjun, Tao Jing, Li Weichao, Shan Xinying, Zhao Bing, Jiang Shangwu, Li Jian, Tao Chunjing: The previous releases of this document and the documents it replaces are: ---First published in:2004 as GB/T 19544-2004; ---This is the first revision: Classification and general technical requirements of spinal orthoses1 ScopeThis document provides the classification of spinal orthoses, and specifies the models, technical requirements, marking labels, instructions for use, packaging, etc: of spinal orthoses: Packaging, transportation and storage, and the corresponding inspection methods are described: This document applies to the design, manufacture, inspection and use of spinal orthoses:2 Normative referencesThe contents of the following documents constitute the essential clauses of this document through normative references in this document: For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document: GB/T 191 Pictorial markings for packaging, storage and transportation GB/T 9174 General technical requirements for general cargo transport packaging GB/T 10000 Chinese adult body dimensions GB/T 14191:3 Prosthetics and orthotics terminology Part 3: Orthotics terminology GB/T 16432 Classification and terminology of rehabilitation assistive devices GB 18401 National basic safety technical specification for textile products GB/T 23315 Velcro GB/T 30659 Requirements and test methods for prostheses and orthoses MZ/T 191 General safety requirements for orthotics contacting the skin3 Terms and definitionsThe terms and definitions defined in GB/T 14191:3, GB/T 16432 and the following apply to this document: 3:1 Spinal orthoses A device used in vitro to correct the structural and functional characteristics of the neuromuscular and skeletal systems of the spine: Note: Some of these devices are custom-made to meet individual functional requirements, some are prefabricated to meet specific functional requirements; some prefabricated ones can be adjusted to meet Some products are ready-made and cannot or do not need to be adjusted due to personal adaptation needs: 3:2 Fixed spinal orthoses Spinal orthoses (3:1) used to stabilize the spine or restrict spinal motion: 3:3 Spinal orthoses (3:1) for reducing spinal pressure: 3:4 Spinal orthoses used to correct or prevent spinal deformities (3:1): ...... |
