YY/T 0694-2020 English PDFUS$119.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0694-2020: Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents Status: Valid YY/T 0694: Historical versions
Basic dataStandard ID: YY/T 0694-2020 (YY/T0694-2020)Description (Translated English): Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 6,637 Date of Issue: 2020-06-30 Date of Implementation: 2021-06-01 Issuing agency(ies): State Drug Administration YY/T 0694-2020: Standard test method for measuring intrinsic elastic recoil of balloon-expandable 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. Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 0694-2008 Standard test method for elastic retraction of balloon expandable stents 2020-06-30 released 2021-06-01 implementation Issued by the State Drug Administration ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0694-2008 "Standard Test Method for Elastic Retraction of Balloon Expansion Stents", and YY/T 0694-2008 In comparison, the main technical changes except for editorial changes are as follows. ---The two ends of the stent have been added as measurement locations (see 7.2); ---Added additional measurement locations determined according to the design properties of the bracket (see 7.2); ---Added the requirement to evaluate the expected maximum implant diameter of the stent (see 7.6). Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is organized by the Cardiovascular Implants Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/ TC110/SC2) Centralized. Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai MicroPort Medical Devices (Group) Co., Ltd., Sino Medical Technology Co., Ltd. The main drafters of this standard. Miao Hui, Zhang Zhenghui, Jiao Yongzhe, Li Yong, Sun Bing, Cao Yishun, Fang Zongtao.IntroductionThe purpose of this test method is to quantify the stent diameter return from the expanded diameter on the balloon to the relaxed diameter after the balloon is decompressed. Shrinkage. This test method can be carried out at room temperature, unless a certain material has a special temperature requirement, the test temperature (if applicable) should be indicated in the report. Standard test method for elastic retraction of balloon expandable stents1 ScopeThis standard specifies the standard test method for the elastic retraction of balloon expandable stents. This standard applies to stents made of materials whose diameter can be plastically deformed before and after release under the action of mechanical methods. Note. This standard does not include all safety issues related to use. The user of this standard is responsible for determining its applicability by establishing an appropriate safety and health evaluation mechanism before use.2 Terms and definitionsThe following terms and definitions apply to this document. 2.1 Nominal diameter labeleddiameter The nominal expansion size of the stent specified by the manufacturer on the label. 2.2 Stent retraction stentrecoil From balloon expansion to balloon decompression, the change in the diameter of the stent is expressed as a percentage.3 Overview of test methodsThe samples that represent the market can be stents that are pre-installed or assembled on the balloon during use. The delivery balloon is expanded to a nominal nominal pressure. When the stent is still on the inflated balloon, measure the outer diameter of the stent at at least 3 axial positions, and each axial position needs to be approximately perpendicular to 2 Measure the outer diameter of the stent in the direction of. After the pressure of the balloon is relieved, the outer diameter is re-measured in the same or close position with the same method.4 Importance and applicationThe minimum stent retraction is a necessary stent characteristic because it can reduce the minimum expansion that must be reached in order to obtain the final release diameter. Large diameter. Compared with a stent with a small retraction rate, a stent with a large retraction rate needs to be expanded to a larger diameter to obtain the final release diameter. real In fact, excessive expansion of blood vessels due to implantation of stents may cause tissue damage and fail to achieve short-term and long-term effects. The retraction of the stent is The inherent characteristics of the support material and the influence of its geometric characteristics. Therefore, measuring the retraction of the stent is an indispensable part of evaluating the stent design. See Appendix A, which contains an explanation of the importance of balloon-expandable stent elastic retraction test.5 Instruments5.1 Use non-compressive liquid (water is a representative liquid) to inflate the delivery balloon of the pre-installed stent. This method can achieve and maintain The pressure required to expand the diameter of the stent allows its diameter to be measured. At the same time, there must be an instrument to monitor the pressure. 5.2 The method of measuring the outer diameter of the stent without deformation, usually using an optical system calibrated and not in contact with the stent. Measurement The resolution of the measurement system should be 0.01mm or higher, and the accuracy of the system should be 2% or higher of the reading. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0694-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 0694-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0694-2020_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0694-2020_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
