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YY/T 1704.3-2021: (Happy Use of Cervix - Part 3: Balloon Type)
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| YY/T 1704.3-2021 | English | 319 |
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(Happy Use of Cervix - Part 3: Balloon Type)
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YY/T 1704.3-2021
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Basic data | Standard ID | YY/T 1704.3-2021 (YY/T1704.3-2021) | | Description (Translated English) | (Happy Use of Cervix - Part 3: Balloon Type) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C36 | | Word Count Estimation | 15,129 | | Issuing agency(ies) | State Drug Administration | YY/T 1704.3-2021: (Happy Use of Cervix - Part 3: Balloon Type)---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.
(Happy Use of Cervix Part 3.Balloon Type)
ICS 11.040.30
C36
People's Republic of China Pharmaceutical Industry Standard
Disposable cervical dilator
Part 3.Balloon
Published on 2021-09-06
2022-09-01 Implementation
Released by the State Drug Administration
foreword
YY/T 1704 "Disposable Cervical Dilator" is divided into the following three parts.
--- Part 1.Progressive;
--- Part 2.Expansion;
--- Part 3.Balloon.
This part is part 3 of YY/T 1704.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee of Family Planning Devices (SAC/TC169).
This section is drafted by. Shanghai Medical Device Testing Institute, Jiangsu Aobojin Pharmaceutical Technology Co., Ltd., Hubei Provincial Medical Device Quality Supervision
Supervision and Inspection Research Institute, Yangzhou Qiangjian Medical Equipment Co., Ltd., Henan Provincial Medical Device Inspection Institute, Hunan Provincial Medical Device Inspection and Testing Institute, Cook
(China) Medical Trading Co., Ltd., Shanghai Heng Instrument Factory Co., Ltd., Jiangsu Aiyuan Medical Technology Co., Ltd.
The main drafters of this section. Yao Tianping, Wu Qianqian, Mei Xianglin, Ye Zhanglin, Zhang Junzi, Yu Liangyu, Xiao Wenlong, Wang Huyu, Qian Xinyi,
Yin He, Zhang Xingxing, Wu Huan, Gui Yujun, Yan Jun, Dong Yimeng, Zhang Aiping, Li Long, Yan Wentao.
Disposable cervical dilator
Part 3.Balloon
1 Scope
This part of YY/T 1704 specifies the classification and requirements of single-use cervical dilator balloon type (hereinafter referred to as balloon cervical dilator).
requirements, test methods, signs, packaging and instructions for use, transportation, storage and sterilization validity.
This section applies to balloon dilators used to dilate a poorly mature cervix before induction of labor at term.
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 edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB/T 1962.1 Syringes, injection needles and other medical devices - 6% (Luer) conical joints - Part 1.General requirements
GB/T 1962.2 Syringes, needles and other medical devices - 6% (Luer) conical connectors - Part 2.Locking connectors
GB/T 9969 General Principles of Instruction Manual for Industrial Products
GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1.Chemical analysis methods
GB/T 15812.1-2005 Non-Intravascular Catheters Part 1.General Performance Test Methods
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in Risk Management Process
YY 0285.1-2017 Intravascular catheters for single-use sterile catheters Part 1.General requirements
YY 0285.4-2017 Intravascular catheters - One-time use sterile catheters - Part 4.Balloon dilatation catheters
YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements
YY/T 0586 Test method for X-ray opacity of medical polymer products
Pharmacopoeia of the People's Republic of China (2020 Edition)
3 categories
3.1 Composition and structure
3.1.1 Balloon cervical dilator can be divided into single balloon and double balloon, as shown in Figure 1, Figure 2 and Figure 3.
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