GB/T 37112-2018 English PDF

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GB/T 37112-2018: Cervical orthoses
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 37112-2018	199	Add to Cart	3 days	Cervical orthoses	Valid

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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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