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YY/T 0693-2008: Standard guide for characterization and presentation of the dimensional attributes of vascular stents
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YY/T 0693-2008: Standard guide for characterization and presentation of the dimensional attributes of vascular stents

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Standard guide for characterization and presentation of the dimensional attributes of vascular stents ICS 11.040.40 C35 People's Republic of China pharmaceutical industry standards Characterization of stent size characteristics (ASTMF2081-06, MOD) Posted 2008-10-17 2010-01-01 implementation State Food and Drug Administration issued

Foreword

The revised standard ASTMF2081-06 "stent dimensions are characterized in" adoption. No technical differences between this standard and ASTMF2081-06 compared to only a small part of the editorial changes and preparation instructions in this standard Listed. Appendix A of this standard is an informative annex. This standard by the national surgical implants and orthopedic instruments Standardization Technical Committee (SAC/TC110) and focal points. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. PROCEEDINGS OF Dongshuang Peng, Li Libin, Fan platinum. Characterization of stent size characteristics

1 Scope

1.1 This includes the identification and detection method recommended clinical performance and effectiveness associated vascular prosthesis size property. This standard also Including stent delivery system during packaging and special identification. 1.2 This standard only points out the dimensional characteristics of the stent. Here it does not indicate the material properties and functional properties of the stent. Described in this standard All dimensions characteristics are measured in vitro test ( "bench") feature. Patient due to various factors, such as vascular compliance, the actual in vivo test Test characteristics may have minor differences. 1.3 This standard includes for metal and alloy balloon-expandable stents and self-expanding stents is the recommended method. This standard is not specifically Do not explain the stent or a polymer coated stent with a biodegradable scaffold or proprietary property, although the standard does not exclude for the above products. 1.4 Although this standard is not specified, but for non-vascular stent placement location, such as esophageal stent or biliary stent, you can still use this Lane include a method to characterize. Also, the standard does not include endovascular grafts or commonly used to treat an aneurysm or peripheral vascular damage or The recommended way to provide other vascular access catheter device, but some of the information covered by this standard may also be used in these devices. 1.5 standard does not include a description as angioplasty catheters sold separately form shaped balloon catheter, the catheter can be used even if some of them No delivery conveyor system is not mounting bracket. Require angioplasty catheters see standard YY 0285.1 and YY 0285.4. 1.6 The main purpose of the standard is to promote the consistency of the label to facilitate clinical users of devices to choose from. The use of international standards Units or derived units, users are accustomed to selected units will be given in the form of brackets.

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. YY 0285.1 Disposable Sterile intravascular catheters - Part 1. General requirements (YY 0285.1-2004, ISO 10555-1. 1995, IDT) YY 0285.4 sterile single-use intravascular catheters - Part 4. Balloon dilatation catheters (YY 0285.4-1999, idt ISO 10555-4.1996)

3 Terms and Definitions

The following terms and definitions apply to this standard. 3.1 At the treatment site by a balloon catheter stent expansion. By balloon dilation, stent shape is changed permanently so that after shrinkage of the balloon Holder should maintain expansion. 3.2 The connection portion of the stent between radial support. Compared with the pillars, the bridge may have unique design features to enhance flexibility and reduce longitudinal retraction. 3.3 By compressing the stent onto the balloon and to ensure that the bracket on the conveyor system. Sold in the form of non-preloaded stent prior to use must be temporary Bed of medical personnel hand crimp. ...