YY/T 0807-2010Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery system (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

The standard reference method using redrafted ASTM F2394-2007 "pre-installed on the delivery system balloon expandable stent stability Standard Test Method can "establishment.

This standard is a technical difference ASTM F2394-2007 deleted Chapter 9 "key words." Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.

1 Scope

This standard is already pre-installed, but not released balloon expandable stent delivery system in the stent delivery system stability performance testing Processing, testing, and end of the test design and development guidance. This standard is intended to help researchers already preinstalled without sheath balloon support Frame delivery system design, research and in vitro characterization.

This standard applies to the laboratory to determine the move or remove pre-installed on a balloon delivery system needed to expand stent shear. The standard Motion offers several options when test rack solid performance to consider. These options include pre-test process, probable stent stability To test and associated test endpoints. It gives an example of a measuring instrument in 7.1.

This standard only applies to the characterization of in vitro tests. Test pretreatment method, stable performance test type (e.g. bracket fixing method) and tested The end of the selection may partly affect the stability of the measured performance levels and product design/processing differences. The characteristics of the body may Differ from the results in vitro.

This standard does not cover all possible test before treatment, the stent solid performance testing and end of the test, is intended to provide a starting point, thereby Stent selection and solid performance testing options.

This standard does not specify the method of mounting bracket on the conveyor system.

This standard does not attempt to all the security issues involved elaborate, even those safety issues associated with their use. establish Appropriate safety and health practices and suitability before applying clear administrative limit, this is the standard user's own responsibility.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

YY 0285.1 Disposable Sterile intravascular catheters - Part 1. General requirements (YY 0285.1-2004, ISO 10555-1. 1995, IDT)

Particular requirements for YY/T 0663-2008 active surgical implants cardiac and vascular implants - Particular requirements for arterial stents (EN 14299:2004, IDT) ASTM E1169 Robustness Test Guidelines (Standardpracticeforconductingruggednesstests)

Standard Guide for Application of statistical procedures (Standardguideforstatistical ASTM E1488 test method development and implementation procedurestouseindevelopingandapplyingtestmethods)

3 Terms and Definitions

The following terms and definitions apply to this document.