GB/T 19544-2024 in English
VALIDClassification and general technology requirements of spinal orthoses
- Issued on:2024-04-25
- Implemented on:2024-08-01
- File Format:PDF
- Delivery:Via email within 5 business days
$301.00
| Standard No: | GB/T 19544-2024 |
| Document status: | VALID |
| Title in English: | Classification and general technology requirements of spinal orthoses |
| Title in Chinese: | 脊柱矫形器的分类及通用技术条件 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 5 business days |
| Issued on: | 2024-04-25 |
| Implemented on: | 2024-08-01 |
| Superseding: |
GB/T 19544-2004 Classification and general technology of spinal orthoses
|
| Chinese Classification: | C45-Extracorporeal circulation, artificial organ and prosthesis device |
| Professional Classification: | GB-National Standard |
| Related Topics: | spine
Classification of columns Post-column conditions Column classification Column classification GBT19544 GBT19544-2004 neck orthosis spinal orthosis Pump types and applicable conditions gb/t -2024 |
《GB/T 19544-2024脊柱矫形器的分类及通用技术条件》由TC148（全国残疾人康复和专用设备标准化技术委员会）归口，主管部门为民政部。
Introduction
GB/T 19544-2024 Standard Overview
This standard specifies in detail the classification, technical requirements and inspection methods of spinal orthoses, and is applicable to the design, manufacture, inspection and use of spinal orthoses.
| Classification dimensions | Functional classification | Part classification | Technical requirements |
|---|---|---|---|
| Function | Fixed type, load-free type, corrective type, compensatory type | - Cervical orthosis- Cervical-thoracic orthosis- Thoracic-lumbar-sacral orthosis | Material properties, structural strength, adaptability |
| Part | - Fixation and protection function | - Lumbar-sacral orthosis- Sacroiliac orthosis | Biomechanical design, correction force distribution |
| Technical characteristics | Corrective force size and direction | - Chest orthosis- Thoracolumbar orthosis | X-ray detection, strength test |
Standard formulation background and technology evolution analysis
Background:Spinal orthosis is increasingly used in rehabilitation medicine, which puts higher requirements on product performance and safety. This standard replaces GB/T 19544-2004, focusing on the classification of chest orthosis and compensatory functions.
Technology evolution:Added biomechanical correction principle, emphasized three-point force system design, and combined with additive manufacturing technology to improve the correction effect. At the same time, the material performance requirements are optimized to ensure the safety of long-term wear.
Implementation Suggestions
Manufacturers: Strictly follow the standards for product design and production, and establish a complete quality inspection system.
Medical institutions: Select appropriate orthoses according to patient needs and guide the correct use of orthoses.
Users: Regularly review the correction effect and adjust or replace orthoses in a timely manner.
Comparison of standard frameworks
| Old standard | New standard | Main changes |
|---|---|---|
| Unclear requirements for correction force distribution | New requirements for three-point force system design | Improve correction accuracy |
| Non-compensation classification | Supplementary definition of compensatory functions | Expand product application scope |
| Simple material requirements | Refine safety performance indicators | Improve product quality stability |
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