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GB/T 37035-2018Classification and identification of wearable products (English PDF)

可穿戴产品分类与标识

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

December 28, 2018

Implementation date

July 1, 2019

Scope

GB/T 37035-2018 is the English-translated version of 可穿戴产品分类与标识.

China's national standard for classifying and identifying wearable products. It specifies the terms and definitions, the abbreviations and the categories, including the classification code and a typing based on the degree of contact between the product and the body. That second axis is the informative one. A wearable that sits in a pocket, one strapped to a wrist, one worn against the skin continuously and one implanted are four different regulatory and engineering propositions, and the difference between them is exactly how close and how long the contact is. Skin contact brings materials requirements - allergens, nickel release, biocompatibility; continuous wear brings thermal and radiofrequency exposure limits; and anything measuring a physiological signal edges toward being a medical device. Classifying by contact rather than by function is therefore the sorting that makes the rest of the requirements assignable, and it is what a standard has to establish before anything else can be said about the category.

Document preview — GB/T 37035-2018

National Standard of the People's Republic of China

ICS
35.180
Classification
L 70

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • 1 Scope1
  • 2 Normative references1
  • 3 Terms and Definitions1
  • 4 Abbreviations2
  • 5 Category2
  • 5.1 Wearable Product Classification Code2
  • 5.4 Type 7 based on the field of application of wearable products 6 logo8

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 is proposed and managed by the National Information Technology Standardization Technical Committee (SAC/TC28). This standard was drafted. China Electronics Technology Standardization Institute, Shenzhen Saixi Information Technology Co., Ltd., Chinese Academy of Medical Sciences Institute of Information, Institute of Biomedical Engineering, Chinese Academy of Medical Sciences, Xiaomi Communication Technology Co., Ltd., Anhui Huami Information Technology Co., Ltd. Division, BOE Technology Group Co., Ltd., Huizhou Desai Industrial Research Institute Co., Ltd., Keda Xunfei Co., Ltd., Lenovo (North Beijing) Co., Ltd., Guangdong Midea Refrigeration Equipment Co., Ltd. The main drafters of this standard. Liu Yizhu, Zhang Zhanxin, Li Yiang, Liu Yu, Gao Shuchen, Wu Sizhu, Sun Xiaokang, Zhang Ze, He Xiaolin, Xu Shengpu, Pu Jiangbo, Zhou Yijia, Zhou Jian, Wang Quanzhong, Chen Saihua, Ma Yuchi, Hu Xiuwen, Lin Biao, Zhou Chunbo, Lin Biao, Chen Weiquan, Liang Yong. Wearable product classification and identification

1 Scope

China's national standard for classifying and identifying wearable products. It specifies the terms and definitions, the abbreviations and the categories, including the classification code and a typing based on the degree of contact between the product and the body. That second axis is the informative one. A wearable that sits in a pocket, one strapped to a wrist, one worn against the skin continuously and one implanted are four different regulatory and engineering propositions, and the difference between them is exactly how close and how long the contact is. Skin contact brings materials requirements - allergens, nickel release, biocompatibility; continuous wear brings thermal and radiofrequency exposure limits; and anything measuring a physiological signal edges toward being a medical device. Classifying by contact rather than by function is therefore the sorting that makes the rest of the requirements assignable, and it is what a standard has to establish before anything else can be said about the category.

This standard classifies wearable products from physical contact, wear position (including product form) and application areas, and specifies corresponding Classification name and logo. This standard applies to the classification and management of wearable products.

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 17969.1-2015 Information technology - Open system interconnection - OSI registration procedures - Part 1 . General rules Top-level arc of Cheng and international object identifier trees

GB/T 26231-2017 National Technical Numbering System and Operating Procedures for Information Technology Open Systems Interconnection Object Identifier (OID)

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Wearable product wearableproduct An intelligent electronic device that can be worn or worn comfortably when worn on the body or in the skin/body. Usually have multiple feelings Know, monitor activity status or physiological indicators, and improve work efficiency.

Note. Wearable products are also known as wearable products or smart wearable products. Usually with a microprocessor, due to the battery in terms of communication and data processing capabilities Capacity limitations may require support from ancillary facilities such as networks, remote services, etc. to provide complete services.

3.2 Close-family product near-bodyproduct Products that are close to the biological body, the device may not be in direct contact with the organism. Example. Watch (unlike the bracelet, no direct contact with the skin).

3.3 Personal product on-bodyproduct Close to the body of the living body, part of the outer surface of the device must be in direct contact with the organism.

3.4 In vivo product in-bodyproduct A product that is implanted in a living body.

3.5 Wearable product application service wearabledevicerelatedservice Wearable products services that process data through information and communication technologies.

Note. Data generated by wearable products include. user physiological data, activity data, environmental data, etc., in order to monitor the user's physiological conditions, expand the user Perceived or increased productivity in use.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.

Referenced standards

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