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YY/T 0808-2010: Standard test methods for in vitro pulsatile durability testing of vascular stents
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Standard test methods for in vitro pulsatile durability testing of vascular stents
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YY/T 0808-2010
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Basic data | Standard ID | YY/T 0808-2010 (YY/T0808-2010) | | Description (Translated English) | Standard test methods for in vitro pulsatile durability testing of vascular stents | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 19,117 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | YY 0500-2004 | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to vessels already in the simulation (simulation elasticity of blood vessels) in the expansion of the stent test sample. This test method by applying a pulsating load makes the stent is similar to the diameter of the in vivo environment to evaluate the level of expansion of the stent durability. Typical endurance test period equivalent to 10 years (72 beats per minute, according to calculations) or at least 348 million times the cardiac cycle. This standard applies to the metal or alloy balloon-expandable stent or a self-expanding stents. While this test method can also be used to coat stents, biodegradable polymer stent or stent products, but not specifically for the unique properties of these scaffolds. This method is not recommended for the treatment of aneurysm or peripheral vascular injury or provide vascular access catheters night stent or other products. But some information may be used in the evaluation of these products. This standard applies to the typical cyclical expansion vessel diameter of the stent failure causes, but does not involve dynamic bending, twisting, stretching, squeezing, or wear as a result of stent failure modes. This method does not involve bending vessel model test conditions. This method does not involve stents overlap test conditions. This standard does not attempt all the security issues involved elaborate, even if necessary, should be combined with its use. Establish appropriate safety and health practices, as well as in the application before the explicit administrative permissions are the standard user's own responsibility. Description This document is the implementation of today's most laboratory testing guidelines. If there are other more effective testing techniques to encourage the use. Regardless of the testing techniques, testers have an obligation to demonstrate specific testing techniques, test equipment and test side | YY/T 0808-2010: Standard test methods for in vitro pulsatile durability testing of vascular stents
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Standard test methods for in vitro pulsatile durability testing of vascular stents
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Stent pulsatile durability Standard Test Method
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 2 Overview of test methods
5 sample size, status and preparation 3
6 Instruments 3
Test Parameters 3 7
8 Test Report 4
Appendix A (normative) Test Method 6
Annex B (informative) Calculation 10
References 15
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference method using redrafted ASTMF2477. "Stent pulsatile durability Standard Test Method for" the preparation of 2007.
This standard ASTMF2477.2007 technical differences are as follows.
--- Deleted the Chapter 9, "precision and bias" and Chapter 10, "keyword";
--- The reference to Appendix X1, Appendix X2 to the Appendix B, remains unchanged.
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.
This standard by the national orthopedic implants and surgical instruments cardiovascular implants Standardization Technical Committee Technical Committee (SAC/TC110 /
SC2) centralized.
This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, minimally invasive medical devices (Shanghai)
Limited.
The main drafters of this standard. Fan platinum Wang Guohui, Ma Chun Bao, Sun Huili, Zhang Lu, Li Yong.
Stent pulsatile durability Standard Test Method
1 Scope
This test method by applying a pulsating fluid load makes the stent is similar to the in vivo environment of the diameter of blood vessels to evaluate the level of expansion
The durability of the stent can. This method has been applied to the test sample holder expansion in the simulated blood vessels (simulated blood vessel elasticity) in. Typical durable
Testing of the equivalent of 10 years (according to 72 beats per minute basis) or at least 380 million times the cardiac cycle.
This method is suitable for balloon expandable stent or metal alloy or self-expanding stents. Although this test method can also be used to coat stents,
Degradable polymer scaffolds or stents, but not specifically for these stents specific properties.
This method is not recommended for the treatment of arterial aneurysm or peripheral vascular damage or to provide vascular access catheter stent graft or other products. but
Some of the information may be used in the evaluation of these products.
This method is applicable due to the typical cyclical expansion vessel diameter leads to stent failure, but does not involve dynamic bending, twisting, stretching, squeezing
Pressure or wear as a result of stent failure mode.
This method does not involve a curved vessel model test conditions.
This method does not involve overlapping stents test conditions.
This standard does not attempt to all the security issues involved elaborate, even if necessary, should be combined with its use. Establish appropriate safety
Health practices, as well as a clear management authority before the application of this standard is the user's own responsibility.
Description --- This document is the guide today most laboratories test implementation. If there are other more effective testing techniques to encourage use.
Whatever the testing technology use, the tester has an obligation to demonstrate a particular test, test equipment and test the feasibility of the application program. this
The standard also includes how to select and proper calibration of all test equipment. And recommendations of the standard deviation from the place might be feasible, but
We need to fully demonstrate techniques to be used.
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 0500-2004 cardiovascular implant artificial blood vessels
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Cardiac cycle cardiaccycle
Diastolic and systolic heart every time a cycle is formed.
3.2
Compliance compliance
Since the cyclic pressure changes caused by changes in blood vessel diameter. Compliance as defined in 8.10.5 YY 0500-2004 expressed as
The percentage change of each 100mmHg pressure caused by changes in the diameter of blood vessels, the following formula.
Compliance (%) =
Dp2-Dp1
Dp1 (p2-p1)
× 104 (1)
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