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YY/T 1798-2021 English PDF

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YY/T 1798-2021: (Happy use of Miyagi balloon)
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YY/T 1798-2021English279 Add to Cart 3 days [Need to translate] (Happy use of Miyagi balloon) Valid YY/T 1798-2021

PDF similar to YY/T 1798-2021


Standard similar to YY/T 1798-2021

YY/T 1783   YY/T 1777   YY/T 1797   YY/T 1921   

Basic data

Standard ID YY/T 1798-2021 (YY/T1798-2021)
Description (Translated English) (Happy use of Miyagi balloon)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Word Count Estimation 13,193
Issuing agency(ies) State Drug Administration

YY/T 1798-2021: (Happy use of Miyagi balloon)

---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 Miyagi balloon) ICS 11.040.30 C36 People's Republic of China Pharmaceutical Industry Standard Disposable intrauterine compression balloon Published on 2021-09-06 2022-09-01 Implementation Released 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 content of this document may be patented. Publication of this document Institutions do not assume responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Family Planning Devices (SAC/TC169). This standard was drafted by. Shanghai Medical Device Testing Institute, Henan Provincial Medical Device Testing Institute, Jiangsu Aobojin Pharmaceutical Technology Co., Ltd., Yangzhou Qiangjian Medical Equipment Co., Ltd., Cook (China) Medical Trading Co., Ltd., Shanghai Heng Instrument Factory Co., Ltd. The main drafters of this standard. Yao Tianping, Wang Haitao, Wu Qianqian, Ye Zhanglin, Xiao Wenlong, Wang Huyu, Qian Xinyi, Zhang Junzi, Zhang Xingxing, Gui Yujun, Dong Yimeng, Zhang Aiping, Yan Wentao. Disposable intrauterine compression balloon

1 Scope

This standard specifies the classification, requirements, test methods, signs and packages of single-use intrauterine compression balloons (hereinafter referred to as intrauterine compression balloons). Packaging and use instructions, transportation and storage, and sterilization expiration date. This standard applies to single-use intrauterine compression for temporary control or reduction of postpartum uterine bleeding by mechanical compression to stimulate the uterus balloon.

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/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements Pharmacopoeia of the People's Republic of China (2020 Edition)

3 categories

3.1 Composition and structure 3.1.1 The uterine cavity compression balloon is usually composed of a catheter tip, a uterine balloon, a catheter tube, a seat, and a valve. 3.1.2 The basic structure of the uterine cavity compression balloon is shown in Figure 1.If it can meet the requirements of this standard, other structural types can also be used. manufacture Therefore, when designing the intrauterine compression balloon, clinical needs, such as the suitability of the tip length, should be considered.

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