GB/T 25304-2010 English PDF

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GB/T 25304-2010: Specific requirements for non-vascular self-expanding metallic stents
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 25304-2010	259	Add to Cart	3 days	Specific requirements for non-vascular self-expanding metallic stents	Valid

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Basic data

Standard ID: GB/T 25304-2010 (GB/T25304-2010)
Description (Translated English): Specific requirements for non-vascular self-expanding metallic stents
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.040.40
Word Count Estimation: 11,134
Date of Issue: 2010-11-10
Date of Implementation: 2011-05-01
Quoted Standard: GB/T 14233.1; GB/T 14233.2; GB/T 15812.1-2005; GB/T 16886.1; GB/T 16886.7; GB/T 16886.13; YY 0500-2004; YY/T 0640-2008; YY/T 0695
Regulation (derived from): National Standard Approval Announcement 2010 No.8 (Total No.163)
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard provides for the expansion of non-vascular cavity narrow self-expanding metal stent and delivery system of terminology and definitions, design attributes, , expected performance materials, pre- clinical evaluation, sterilization, , manufacture of packaging and information supplied by the manufacturer. This standard applies to non-vascular interventional therapeutic self-expanding metal stents (stents or can be covered stent), including esophageal stent, biliary stent, tracheal stent and its corresponding delivery systems. This standard does not apply to a balloon expandable stent, balloon-expandable stent recommended reference YY/T 0663.

GB/T 25304-2010: Specific requirements for non-vascular self-expanding metallic stents

---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.
Specific requirements for non-vascular self-expanding metallic stents ICS 11.040.40 C45 National Standards of People's Republic of China Non-vascular self-expanding metal stent special requirements Issued on. 2010-11-10 2011-05-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Preface Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions Expected performance 2 4 5 Design Properties 2 6 material 2 Pre-clinical evaluation 3 7 Manufacturing 8 5 5 9 Sterilization 10 Package 5 11 information supplied by the manufacturer 5

Foreword

This standard was proposed by the State Food and Drug Administration. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) centralized. This standard was drafted. Yes REVIEW billion of the new Materials Co., Ltd., Tianjin, the State Food and Drug Administration Medical Device Quality Supervision Inspection Center. The main drafters of this standard. Feng Jing Su, Fan platinum, Hu Yuling, Miao Weidong, Li Juntao, Kouya Ming, Zhang Henkin, in school security.

Introduction

Non-vascular self-expanding metal stents (including esophageal stents, biliary stents and tracheal stent) and their corresponding delivery systems in recent years has been in clinical Medicine widely used to regulate the production, testing, distribution and use of formulated standards for such products. The criterion-referenced using YY/T 0640, YY/T 0663 and the US FDA Center for Devices and Radiological Safety "on the esophagus and trachea false Guide body prior to listing announcement "and" on the expandable metal biliary stent premarket guidance announcement "related content. Non-vascular self-expanding metal stent special requirements

1 Scope

This standard specifies the terms and definitions used in the expansion of non-vascular cavity narrow self-expanding metal stent and delivery system, expected performance, Design attributes, materials, in preclinical evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This standard applies to non-vascular interventional treatment with self-expanding metal stents (stents can be bare or covered stents, hereinafter referred to as the holder), including Esophageal stents, biliary stents, tracheal stents and their corresponding delivery systems. This standard does not apply to balloon expandable stents, balloon-expandable stent recommendation reference YY/T 0663.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods GB/T 15812.1-2005 non-vascular catheter within Part 1. General performance test methods GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals GB/T 16886.13 Biological evaluation of medical devices - Part 13. qualitative and quantitative degradation products from polymeric medical devices YY0500-2004 cardiovascular implant artificial blood vessels YY/T 0640-2008 active surgical implants General requirements YY/T 0695 small implantable devices Corrosion Susceptibility cycle potentiodynamic polarization Standard Test Method

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 Non-vascular stents non-vascularstent And support for expanding the esophagus, trachea, biliary lumen implantable tubular structure. 3.2 Bare stent barestent Not coated or uncoated stents. 3.3 Stent graft stentwithcoating Good biological properties polymeric membrane coated stent. 3.4 Delivery system deliverysystem For the stent delivery system or device targeting location, and then removed. 3.5 MRI compatibility MRIcompatibility The stand for a particular MRI (magnetic resonance imaging) environments, such as the following conditions, the bracket is compatible with MRI. ......

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