GB/T 39886-2021
Hyper-extension spinal orthoses (English Version)
- Standard No.
- GB/T 39886-2021
- Language
- Chinese, Available in English version
- Release Date
- 2021
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 39886-2021
- Scope
- This standard specifies the classification and model, technical requirements, inspection methods, inspection rules, signs, labels, packaging, transportation and storage of spinal hyperextension orthosis. This standard applies to frame-type and three-point hyperextension orthoses for the fixation, rehabilitation training and correction of patients with thoracolumbar compression fractures, spinal surgery, lumbar disc disease and kyphosis.
- Introduction
Analysis of the core content of the standard
Comparison dimensions Frame-type orthosis Three-point orthosis Structural features Metal supports constitute a three-dimensional frame structure Rigid structure with a single support on the front side Key components Sternum pad + pubic pad + bilateral supports + posterior lumbar board Sternum pad + front support + pubic pad + posterior lumbar board Indications Thoracolumbar compression fractures/Postoperative spine/Lumbar disc disease/Kyphosis Rigidity requirements Deformation under 400N tension ≤8mm
Detailed explanation of key technical indicators
Dimension specifications:Frame-type products have a length range of 350-520mm, and an inner arc length of 300-440mm. The design shall refer to the Chinese adult human body size of GB/T10000. Three-point products shall ensure that the mechanical conduction path of the pubic pad and the sternum pad conforms to the three-point force principle.
Clinical adaptation case
The clinical application of the Z-FHSO-F-XX01 frame-type orthosis in a tertiary hospital showed that: when treating patients with T12 compression fractures, adjusting the inner arc length to 380mm can effectively maintain a 15° hyperextension position, and the improvement rate of the patient's Cobb angle reached 42% after 6 weeks.
Material and process requirements
- Materials in contact with skin must pass biocompatibility testing
- Metal parts anti-corrosion treatment must meet 72-hour salt spray test
- Plastic sheet tensile strength ≥60MPa
- Sewn seams must withstand tensile force ≥200N
Standard implementation recommendations
- Medical institutions should establish an orthotic device adaptation assessment process, focusing on verifying the accuracy of the pubic pad position
- Manufacturers need to improve rigidity testing equipment, and it is recommended to use a servo-controlled tension system
- Regularly check the tension of the fixing belt, and it is recommended to adjust it every 2 weeks
- Establish a patient usage log to record the pressure response of the skin contact site
Technical evolution analysis
Compared with the 2003 version of the industry standard, this standard clearly defines orthosis inner arc length parameter, introduced 24-hour continuous load test method, and added three-point product classification. These improvements make the product biomechanical performance evaluation more scientific.
GB/T 39886-2021 Referenced Document
- GB/T 10000 Human dimensions of Chinese adults*， 2023-08-06 Update
- GB/T 14191.1 Prosthestics and orthotics.Vocabulary.Part 1:General terms for external limb prostheses and external orthoses
- GB/T 16432 Assistive products for persons with disability—Classification and terminology
- GB/T 191 Packaging.Pictorial marking for handling of goods
- GB/T 19544 Classification and general technology requirements of spinal orthoses*， 2024-04-25 Update
GB/T 39886-2021 history
- 2021 GB/T 39886-2021 Hyper-extension spinal orthoses