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			| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF | 
		 
			| YY/T 1624-2019 | English | 179 | 
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                    Manual negative pressure cupping apparatus
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                    YY/T 1624-2019
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  Basic data             |  Standard ID  |          YY/T 1624-2019 (YY/T1624-2019) |               |  Description (Translated English)  |          Manual negative pressure cupping apparatus |               |  Sector / Industry  |          Medical Device & Pharmaceutical Industry Standard (Recommended) |               |  Classification of Chinese Standard  |          C42 |               |  Classification of International Standard  |          11.040.60 |               |  Word Count Estimation  |          9,998 |               |  Date of Issue  |          2019 |               |  Date of Implementation  |          2020-10-01 |               |  Issuing agency(ies)  |          State Drug Administration |               |  Summary  |          This standard specifies the terms and definitions, classification and composition, requirements and test methods of manual negative pressure cupping devices. This standard applies to traditional Chinese medicine appliances for non-pyrogenic cupping therapy that generate negative pressure in a closed tank that fits the corresponding position of the human skin by manual means. ), if other functions have corresponding national standards and (or) industry standards, they should also meet the requirements of other relevant standards. This standard does not apply to: Cupping appliances (pot-shaped appliances that generate negative pressure by combustion), such as cupping, glass cupping, bamboo cupping, disposable cupping, bloodletting cupping; negative pressure), such as electric cupping device; plastic cupping (apparatus that generates negative pressure by squeezing the can body deformation), such as |         
  YY/T 1624-2019: Manual negative pressure cupping apparatus---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.  
Manual negative pressure cupping apparatus
ICS 11.040.60
C42
People's Republic of China Pharmaceutical Industry Standard
Manual negative pressure cupping device
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some elements of this document may involve patents. Publication of this document
The agency is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Medical Electrical Standardization Technical Committee Physical Therapy Equipment Sub-Technical Committee (SAC/TC10/SC4).
This standard was drafted. Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Medical Device Technology Evaluation Center.
The main drafters of this standard. Qi Lijing, Gao Shan, Zhang Xiuli, Zhang Huan, Qian Xuebo, Yang Guojuan, Zhang Qian.
Manual negative pressure cupping device
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements, and test methods of manual negative pressure cupping devices.
This standard applies to non-heat-generating sources that produce negative pressure in a closed tank that fits to the corresponding position of human skin by manual means.
Cupping treatment of traditional Chinese medical equipment, for multifunctional products (such as magnetic therapy, far infrared and other functions at the same time), other functions such as the corresponding national standard
Standards and/or industry standards should also meet the requirements of other relevant standards.
This standard does not apply to.
--- Fruit pot appliances (pot-shaped appliances that generate negative pressure by burning), such as fire pots, glass fire pots, bamboo fire pots, disposable cupping devices,
Blood cupping.
--- Can treatment equipment (the negative pressure generated in the tank by electric negative pressure source), such as electric cupping device.
--- Plastic cupping (devices that generate negative pressure by squeezing the deformation of the tank body), such as silicone cupping devices.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 16886.1-2011 Biological evaluation of medical devices. Part 1. Evaluation and testing in the process of risk management
(ISO 10993-1..2009, IDT)
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Non-thermal source cupping treatment that produces negative pressure in a closed tank that fits to the corresponding position of human skin by manual method
Medical appliances.
3.2
Bodyofthecuppingapparatus
A transparent body with a wide mouth and an internal cavity, the bottom edge of the wide mouth is in contact with the skin of the human body.
Pressure, for TCM cupping treatment.
3.3
Suction device suctiondevice
A device connected to the air inlet and outlet above the tank body to manually generate a negative pressure in the tank body.
3.4
Valve unit
The device is installed at the air inlet and outlet of the tank, and is used for controlling and sealing the air in and out of the tank.
3.5
Rotatinghandle
Manual adjustment device for changing the negative pressure strength of the inner cavity of the tank in a rotating manner.
   
   
  
  
    
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