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GB/T 19544-2024: Classification and general technology requirements of spinal orthoses
Status: Valid GB/T 19544: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 19544-2024 | English | 439 |
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Classification and general technology requirements of spinal orthoses
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GB/T 19544-2024
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| GB/T 19544-2004 | English | 479 |
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Classification and general technology of spinal orthoses
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GB/T 19544-2004
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PDF similar to GB/T 19544-2024
Basic data | Standard 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Count Estimation | 22,210 | | Date of Issue | 2024-04-25 | | Date of Implementation | 2024-08-01 | | Older Standard (superseded by this standard) | GB/T 19544-2004 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T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 Contents
Preface 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 13
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 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 orthoses
1 Scope
This 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 references
The 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 skin
3 Terms and definitions
The 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):
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