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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

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