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YY/T 0807-2010: Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery system
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0807-2010 | English | 489 |
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Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery system
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YY/T 0807-2010
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Basic data | Standard ID | YY/T 0807-2010 (YY/T0807-2010) | | Description (Translated English) | Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery system | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 21,224 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | YY 0285.1; YY/T 0663-2008; ASTM E1169; ASTM E1488 | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard provides a solid performance in the test stand to consider some options. This standard is already pre-installed, not yet released the balloon-expandable stent delivery system of the stent delivery system in a solid performance testing pre-treatment, testing and test endpoints to provide guidance for the design and development. This standard is intended to assist researchers already preloaded, no sheath balloon-expandable stent delivery system design, research and in vitro characterization. This standard applies to determine the real face of room to move or remove the pre-installed conveyor system balloon-expandable stent on the required shear force. These options include pre-treatment tests, probable stent solid performance testing and related endpoints. In test 7. 1 gives an example of the instrument. This standard applies only to the characterization of in vitro testing. Test method for pre-treatment, stable performance test type (such as stents fixing method) and the end of the test of choice may be partly measured by the solid performance levels and product design/process caused by differences affected. Characteristics vivo and in vitro results may also differ. This standard does not cover all possible test before treatment, side stand firm performance test and test endpoints, intended to provide a starting point, thereby selecting and study the performance side of the bracket Degussa trial option. This standard specifies the bracket to cast a conveyor system approach. This standard does not attempt all the security issues involved elaborate, even those safety issues associated with their use. Establish appropriate safety and health practices, as well as in the application of the applicability of regulatory limitations prior to clear, is the standard user's own responsibility. | YY/T 0807-2010: Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery 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.
Standard guide for measuring securement of balloon expandable vascular stent mounted on delivery system
ICS 11.040.40
C35
People's Republic of China pharmaceutical industry standards
Preinstalled on the delivery system balloon stent
Standard Test Method for solid performance
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 4 Significance and Use
5 4 clinical status
6 Detection 4
7 instruments and procedures Example 8
8 9 Test Report
Appendix A (normative) theory and examples 12
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
The standard reference method using redrafted ASTMF2394-2007 "pre-installed on the delivery system balloon expandable stent stability
Standard Test Method can "establishment.
This standard is a technical difference ASTMF2394-2007 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.
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)
Ltd., Dalian University Institute of Biomedical Engineering.
The main drafters of this standard. Fan platinum Wang Guohui, Jiaoyong Zhe, Li Nan, Sun Huili, Chen Tao, Dong Heyan, Mazong Min.
Preinstalled on the delivery system balloon stent
Standard Test Method for solid performance
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
(EN14299.2004, IDT)
ASTME1169 Robustness Test Guidelines (Standardpracticeforconductingruggednesstests)
Standard Guide for Application of statistical procedures (Standardguideforstatistical ASTME1488 test method development and implementation
procedurestouseindevelopingandapplyingtestmethods)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Balloon-expandable stent baloonexpandablestent
Expandable stent at the treatment site by a balloon catheter. Scaffold due to balloon dilatation and plastic deformation, after the balloon is evacuated branched
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