GB/T 25304-2025Non-vascular self-expanding metallic stent system (English PDF)

Foreword

This document has been drafted in accordance with the provisions of GB/T 1.1-2020 "Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents".

the following main technical changes have been made with respect to GB/T 25304-2010:

conditions", "oesophageal stent", "tracheal stent" and "biliary stent" have been deleted, and the term and definition of "non-vascular self-expanding metallic stent" has been added (see Chapter 3; Chapter 3 of the 2010 edition);

between the retrieval loop and the stent, suture strength (if applicable) (see 8.2.7), anti-reflux test (if applicable) (see 8.2.8) and corrosion resistance (see 8.2.9) have been added;

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying patent rights.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Surgical Implants and Orthopaedic Devices of Standardization Administration of China (SAC/TC Drafting organizations of this document: Grinm Medical Devices (Beijing) Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, Nanwei Medical Science and Technology Co., Ltd., Beijing Youzhuo Zhenglian Medical Technology Co., Ltd., Beijing Institute of Medical Device Testing (Beijing Medical Bio-protective Equipment Testing and Chinastandards.org Research Center), Shandong Ande Medical Products Co., Ltd.

Pan Changgang, Li Juntao, Fu Tianxiang, Sun Lu, Wang Shilin.

The releases of this document and the documents it replaces are as follows:

1 Scope

This document specifies the requirements for the intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied (hereinafter referred to as stents) and their delivery systems.

This document is applicable to non-vascular self-expanding metallic stents (bare stents or covered stents) for interventional therapy, including oesophageal stents, biliary stents, tracheal stents, intestinal stents, urethral stents, etc., and their corresponding delivery systems.

2 Normative references

the version corresponding to that date is applicable to this document; for undated references, the latest version (including all amendments) is applicable to this document.

single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices YY/T 0987.1 Surgical implants — Magnetic resonance compatibility — Part 1: Safety marking

3 Terms and definitions

The following terms and definitions apply to this document.

4 Classification 4.1

Stents (bare stents or covered stents) are classified according to their implantation site into oesophageal stents, biliary stents, tracheal stents, intestinal stents, urethral stents, etc.

An oesophageal stent is a tubular device used for implantation into, or external attachment to, the chest and throat, to continuously restore the patency of the oesophagus or pharynx.

A biliary stent is a tubular device used for implantation into the biliary tract to treat and relieve malignant strictures.

A tracheal stent is a tubular device used for implantation to reconstruct the trachea.

An intestinal stent is a tubular structure composed wholly or partly of metal, implanted into the intestinal tract for the treatment and relief of malignant strictures or obstructions, etc.

A urethral stent is a device used for the treatment of urethral stricture or obstruction, which maintains the patency of the urethra by implantation into the urethra.

5 Intended performance

The intended performance shall comply with the requirements of Clause 4 of YY/T Chinastandards.org

6 Design attributes

The design attributes shall comply with the requirements of Clause 5 of YY/T 0640-2016.

7 Materials

Materials shall comply with the requirements of Clause 6 in YY/T 0640-2016. For certain materials, additional testing shall be carried out to determine the suitability of the material for its design use.

EXAMPLE: Nickel-titanium materials having shape memory characteristics shall be subjected to tests such as phase transformation temperature and shape recovery rate to evaluate their phase transformation characteristics; the corrosion resistance of the material shall meet the intended clinical use requirements.

8 Design evaluation

9 Manufacture

Manufacture shall comply with the requirements of Clause 8 of YY/T 0640-2016.

10 Sterilization

11 Packaging

Packaging shall comply with the requirements of Clause 10 in YY/T 0640-2016.

12 Information supplied by the manufacturer

Bibliography

medical use — Part 1: Chemical analysis methods medical use — Part 2: Biological test methods Requirements for regulatory purposes measurement of corrosion susceptibility of small implant devices method for magnetically induced displacement force Evaluation method for image artefacts method for radio frequency induced heating method for magnetically induced torque Chinastandards.org