YY/T 1554-2017Oviduct catheter (English PDF)
输卵管导管
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 2, 2017
Implementation date
April 1, 2018
Scope
YY/T 1554-2017 is the English-translated version of 输卵管导管.
YY/T 1554-2017 is the Chinese pharmaceutical industry standard for the oviduct catheter, the catheter passed through the vagina and the uterine cavity under hysteroscopy or digital subtraction fluoroscopy to image or clear the fallopian tubes.
It gives the composition and the classification, the requirements, the test methods, the marks and instructions for use and the rules for packaging, transport and storage, covering the dimensions and the flexibility, the guide wire and the balloon where fitted, the connections and their tightness, the radiopacity, the materials and their biological evaluation, and sterility. Issued on 2 May 2017, it has applied since 1 April 2018.
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Document preview — YY/T 1554-2017
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 36
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Composition and classification
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
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 document. 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
3.2 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.
3.1 Tubal catheter by the catheter
(including seat) (hereinafter referred to as "catheter") and the guide wire.
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 1962.2Conical fittings with a 6 %(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
- GB/T 9969General principles for preparation of instructions for use of industrial products
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY 0450.1-2003Accessory devices for sterile single-use intravascular catheters - Part 1: Introducers
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Related Standards
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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