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YY/T 1554-2017 English PDF

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YY/T 1554-2017: Oviduct catheter
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1554-2017239 Add to Cart 3 days Oviduct catheter Valid

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Basic data

Standard ID: YY/T 1554-2017 (YY/T1554-2017)
Description (Translated English): Oviduct catheter
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C36
Classification of International Standard: 11.040.30
Word Count Estimation: 12,143
Date of Issue: 2017-05-02
Date of Implementation: 2018-04-01
Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 49
Issuing agency(ies): State Food and Drug Administration

YY/T 1554-2017: Oviduct catheter

---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.
Oviduct catheter ICS 11.040.30 C36 People's Republic of China pharmaceutical industry standards Tubal catheter 2017-05-02 released 2018-04-01 implementation State Food and Drug Administration released

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The release of this document The agency does not assume responsibility for identifying these patents. This standard is proposed and managed by the National Planned Parenthood Equipment Standardization Technical Committee (SAC/TC169). This standard was drafted unit.Shanghai Heng Instrument Factory Co., Ltd., Shanghai Medical Device Testing Institute, Shanghai Medical Kang pigeon medical equipment limited liability Any company. The main drafters of this standard. Wang Hu Yu, Yao Tianping, Zhu Sun Yu, Yan Wentao, Zou Bing, Chi Chi. Tubal catheter

1 Scope

This standard specifies the composition and classification of tubal catheters, requirements, test methods, signs and instructions for use, packaging, transportation and storage. This standard applies to the fallopian tube catheter, the product for the hysteroscopy or digital subtraction radiography (DSA) screen under the supervision of the guide wire Instruments, vaginal access to the uterine cavity for the uterine interstitial tubal imaging, clear.

2 Normative references

The following documents for the application of this document is essential. 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 Packaging - Pictorial signs GB/T 1962.2 Syringes, needles and other medical devices 6% (Ruhr) conical fittings Part 2. Locking fittings GB/T 9969 Industrial Products Manual General GB/T 14233.1-2008 medical infusion, transfusion, injection apparatus test methods - Part 1. Chemical analysis methods Nonvascular catheters - Part 1. General performance test methods GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and test in risk management process Sterile intravascular catheters for single use - Part 1. General requirements YY 0450.1-2003 Disposable sterile endotracheal tube accessories - Part 1. Guiding instruments Pharmacopoeia of the People's Republic of China (2015 Edition)

3 composition and classification

3.1 tubal catheter by the catheter (including seat) (hereinafter referred to as "catheter") and the guide wire. 3.2 The type of catheter should be consistent with the provisions of Figure 1. 3.3 guide wire inserted into the uterine cavity and positioning of flexible instruments. According to the first type is divided into straight and J-shaped. Guide wire type should be consistent with Figure 2 Provisions. Note. The most recent clinical use of guidewire types may differ from Figure 2, and manufacturers should be encouraged to develop new products that will reduce the inspected subject's injury to
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