YY/T 1554-2017 (YY/T1554-2017, YYT 1554-2017, YYT1554-2017)
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| YY/T 1554-2017 | English | 239 |
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Oviduct catheter
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YY/T 1554-2017
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Standards related to: YY/T 1554-2017
| 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 | 12,125 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Drafting Organization | Shanghai Heng Instrument Factory Co., Ltd., Shanghai Medical Device Testing, Shanghai Medical Kang pigeons medical equipment limited liability company | | Administrative Organization | National Planned Parenthood Equipment Standardization Technical Committee (SAC/TC 169) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 49 | | Proposing organization | National Planned Parenthood Equipment Standardization Technical Committee (SAC/TC 169) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1554-2017
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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