Path: Home > GB/T > Page591 > GB/T 25304-2025 Home > Standard_List > GB/T > Page591 > GB/T 25304-2025

GB/T 25304-2025 English PDF

US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 25304-2025: Non-vascular self-expanding metallic stent system
Status: Valid

GB/T 25304: Evolution and historical versions

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
GB/T 25304-2025	English	279	Add to Cart	3 days [Need to translate]	Non-vascular self-expanding metallic stent system	Valid	GB/T 25304-2025
GB/T 25304-2010	English	259	Add to Cart	3 days [Need to translate]	Specific requirements for non-vascular self-expanding metallic stents	Valid	GB/T 25304-2010

Standard similar to GB/T 25304-2025

GB/T 25304 GB/T 50034 GB/T 50082

Basic data

Standard ID	GB/T 25304-2025 (GB/T25304-2025)
Description (Translated English)	Non-vascular self-expanding metallic stent system
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C45
Classification of International Standard	11.040.40
Word Count Estimation	14,137
Date of Issue	2025-10-05
Date of Implementation	2026-11-01
Older Standard (superseded by this standard)	GB/T 25304-2010
Issuing agency(ies)	State Administration for Market Regulation and Standardization Administration of China

GB/T 25304-2025: Non-vascular self-expanding metallic stent system

---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.
ICS 11.040.40 CCSC45 National Standards of the People's Republic of China Replaces GB/T 25304-2010 Non-vascular self-expanding metallic stent system Published on 2025-10-05 Implemented on 2026-11-01 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Preface III 1.Scope 1 2 Normative References 1 3.Terms and Definitions 1 4.Classification 2 5.Expected Performance 2 6 Design Attributes 2 7.Materials 3 8 Design Evaluation 3 9 Manufacturing 5 10 Sterilization 5 11 Packaging 6 12 Information provided by the manufacturer 6 References 8

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. This document supersedes GB/T 25304-2010 "Specific Requirements for Non-Vascular Self-Expanding Metal Stents" and is consistent with GB/T 25304-2010. Compared to previous versions, aside from structural adjustments and editorial changes, the main technical changes are as follows. ---The terms "non-vascular stent," "self-expanding stent," "nominal condition," "esophageal stent," "tracheal stent," and "biliary stent" have been removed. The definition section adds the term and definition of "non-vascular self-expanding metallic stent" (see Chapter 3, Chapter 3 of the.2010 edition); ---Added a classification of stents (see Chapter 4); ---The corrosion properties of the material have been removed (see section 6.2 in the.2010 edition); ---Added improvements to the appearance of the support (see 8.2.6), the connection strength between the suture loop and the support, the stitch strength (if applicable) (see 8.2.7), and the anti-reverse mechanism. Laboratory tests for flow resistance (if applicable) (see 8.2.8) and corrosion resistance (see 8.2.9); ---Added laboratory testing items for the appearance of the conveying system (see 8.3.8); ---Added content on preclinical evaluation and post-marketing follow-up (see 8.6, 8.7); ---The sterilization requirements have been changed (see Chapter 10, Chapter 9 in the.2010 edition). Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document was drafted by. GRINM Medical Devices (Beijing) Co., Ltd., Tianjin Medical Device Quality Supervision and Inspection Center, and Nanwei Medical Science Department. Technology Co., Ltd., Beijing Youzhuo Zhenglian Medical Technology Co., Ltd., Beijing Institute for Medical Device Testing (Beijing Medical Biological Protection) Equipment Inspection and Research Center), Shandong Ande Medical Supplies Co., Ltd. The main drafters of this document are. Wang Zhenqiang, Yu Xuebao, Qiao Jiaqi, Duan Qingjiao, Pan Changwang, Li Juntao, Fu Tianxiang, Sun Lu, and Wang Shilin. The release history of this document and the document it replaces is as follows. ---First published in.2010 as GB/T 25304-2010; ---This is the first revision. Non-vascular self-expanding metallic stent system

1 Scope

This document specifies the expected performance and design of self-expanding metallic stents (hereinafter referred to as stents) and their delivery systems for use in non-vascular cavities. Requirements for information provided by the manufacturer regarding attributes, materials, design evaluation, manufacturing, sterilization, packaging, and the manufacturer. This document applies to non-vascular self-expanding metallic stents (bare stents or covered stents) used in interventional therapy, including esophageal stents, biliary stents, Tracheal stents, intestinal stents, urethral stents, and their corresponding delivery systems.

2 Normative references

The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document. GB/T 15812.1-2005 Non-vascular catheters – Part 1.General performance test methods GB/T 16886.1 Biological evaluation of medical devices – Part 1.Evaluation and testing in the risk management process GB 18278.1 Sterilization of medical and health care products by moist heat - Part 1.Development, validation and routine control of sterilization processes for medical devices Require GB 18279 Sterilization of Medical and Healthcare Products - Development, Validation, and Routine Control Requirements for Ethylene Oxide Sterilization Processes for Medical Devices GB 18280.1 Sterilization radiation for medical and health care products – Part 1.Development, validation and routine control of sterilization processes for medical devices Require GB/T 19974 Characteristics of sterilizing agents for sterilization of medical and health care products and development, validation and routine control of sterilization processes for medical devices General requirements GB/T 42062 Application of Risk Management for Medical Devices YY/T 0500-2021 Cardiovascular Implants, Vascular Prostheses, Tubular Vessel Grafts and Vascular Patches YY/T 0640-2016 General Requirements for Passive Surgical Implants YY0970 Sterilization of Healthcare Products. Liquid chemical sterilizing agent for single-use animal-derived medical devices. Requirements for process characteristics, development, validation, and routine control YY/T 0987.1 Surgical implants - Magnetic resonance compatibility - Part 1.Safety markings

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 An implantable tubular metal structure used to expand and support the lumen of non-vascular sites such as the esophagus, bile duct, trachea, intestines, and urethra, from a delivery device. After release, the diameter increases from the pre-release size to the post-release size, a process that does not rely on balloon inflation or other mechanical assistance. 3.2 Bare stent A support frame without a coating or film.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 25304-2025_English be delivered?

Answer: Upon your order, we will start to translate GB/T 25304-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 25304-2025_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 25304-2025_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version GB/T 25304-2025?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 25304-2025 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.