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YY/T 1624-2019

Chinese Standard: 'YY/T 1624-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1624-2019English169 Add to Cart Days<=3 Manual negative pressure cupping apparatus Valid YY/T 1624-2019
YY/T 1624-2019Chinese18 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

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 9,929
Date of Issue 2019-10-23
Date of Implementation 2020-10-01
Quoted Standard GB/T 16886.1-2011
Drafting Organization Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Medical Device Technology Evaluation Center
Administrative Organization Physical Technical Committee of National Medical Electrical Standardization Technical Committee (SAC / TC 10 / SC 4)
Regulation (derived from) Announcement of the State Drug Administration No. 84 of 2019
Proposing organization State Drug Administration
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 is applicable to traditional Chinese medical appliances that produce negative pressure in a closed tank that fits to the corresponding position of the human skin by manual means, which is a non-pyrogenic cupping treatment.For multifunctional products (such as magnetic therapy, far infrared and other functions at the same time) ), Other functions, if corresponding national standards and / or industry standards, should also meet the requirements of other relevant standards. This standard does not apply to: ��fire pot appliances (pot-shaped appliances that generate negative pressure by burning), such as fire pots, glass fire pots, bamboo fire pots, disposable cup holders, and bloodletting cupping. �� Can therapy equipment (negative pressure is generated in the tank by electric negative pressure source), such as electric cupping device. ��Plastic cupping (apparatus for generating negative pressure by squeezing the deformation of the tank body)

YY/T 1624-2019
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.
Related standard:   YY/T 1626-2019  YY/T 1685-2020
Related PDF sample:   YY/T 1095-2015  YY 0950-2015
   
 
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