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GB/T 37112-2018: Cervical orthoses
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 37112-2018 | English | 199 |
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Cervical orthoses
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GB/T 37112-2018
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Basic data | Standard ID | GB/T 37112-2018 (GB/T37112-2018) | | Description (Translated English) | Cervical orthoses | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C45 | | Classification of International Standard | 11.180 | | Word Count Estimation | 10,178 | | Date of Issue | 2018-12-28 | | Date of Implementation | 2019-07-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 37112-2018: Cervical 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.
Cervical orthoses
ICS 11.180
C45
National Standards of People's Republic of China
Neck orthosis
Published on.2018-12-28
2019-07-01 implementation
State market supervision and administration
China National Standardization Administration issued
Content
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Classification and Model 2
5 Requirements 3
6 Test Method 4
7 Inspection rules 6
8 logo label, instruction manual 6
9 Packaging, transportation and storage 7
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the Ministry of Civil Affairs of the People's Republic of China
This standard is under the jurisdiction of the National Technical Committee for the Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148).
This standard was drafted. China Rehabilitation Aids Association, National Rehabilitation Aids Research Center, Beijing Global Jingbo Rehabilitation Aids Technology
Limited company, Beijing Huici Prosthetic Medical Products Development Co., Ltd.
The main drafters of this standard. Li Guiling, Wang Ying, Hou Ligang, Xu Jing, Zhang Xiaoyu, Gu Huiru, Zhang Pengcheng.
Neck orthosis
1 Scope
This standard specifies the classification, model, requirements, inspection methods, inspection rules, marking, packaging, transportation and storage of neck orthoses.
This standard applies to soft neck orthosis, hard neck orthosis finished products, fixed products and parts, this product is used for neck injury, neck
Fixation, correction, protection, support, etc. of inflammation and other neck diseases, as well as assisted rehabilitation before and after neck surgery.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon
GB/T 9174 General technical conditions for general cargo transportation and packaging
GB/T 10000 Chinese adult body size
GB/T 14191.1 Prosthetics and orthotics - Part 1 . Basic terms for external limb prostheses and external orthoses
GB/T 16432 Classification and terminology of rehabilitation aids
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test
GB/T 23315 Velcro tape
3 Terms and definitions
The following terms and definitions as defined in GB/T 14191.1 and GB/T 16432 apply to this document.
3.1
An orthosis that surrounds all or part of the cervical region.
3.2
A neck orthosis made of a soft material such as a composite fabric or an ethylene-vinyl acetate copolymer (EVA) foam.
3.3
A neck orthosis made of a hard material such as plastic or metal frame.
3.4
A neck orthosis with a fixed neck or neck movement as the main function.
3.5
A neck orthosis with a primary function of correcting and preventing neck deformities.
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