YY/T 0694-2020 in English
VALIDStandard test method for measuring intrinsic elastic recoil of balloon-expandable stents
- Issued on:2020-06-30
- Implemented on:2021-06-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$97.00
本标准规定了球囊扩张支架弹性回缩的标准测试方法。本标准适用于在机械方法作用下，支架直径能在释放前后发生塑性形变的材料制成的支架。
Introduction
Core changes in the standard revision
| Technical parameters | 2008 version | 2020 version | Clinical significance |
|---|---|---|---|
| Measurement site | Mainly the middle site | Add both ends + design-related special sites | More comprehensive evaluation of the axial performance consistency of the stent |
| Diameter evaluation | Nominal diameter | Increase the maximum implant diameter evaluation | Reduce the risk of excessive vascular dilation |
Analysis of key test elements
1. Instrument Selection Specifications
The standard clearly requires the use of a non-contact optical measurement system with a resolution of 0.01mm and an accuracy of 2% of the reading. Typical configurations include:
- High-precision microscopic camera system (magnification of more than 200 times)
- Digital image analysis software (sub-pixel edge detection algorithm)
- Constant temperature control device (±1℃ fluctuation range)
2. Measurement site optimization
The new standard requires at least 3 types of measurement sites:
- Axial middle position (traditional measurement point)
- Within 5mm of both ends of the stent (new key points)
- Design-specific areas (such as where the density of the connecting rod changes)
Clinical relevance analysis
Typical application scenarios
After testing a certain brand of coronary stent according to the new standard, it was found that:
- The proximal recoil rate (4.2%) was significantly higher than that in the middle part (3.1%)
- The recoil rate fluctuated by 1.8 percentage points at the maximum implant diameter
This prompted the company to optimize the stent end mesh design, reducing the vascular injury rate by 12% during clinical implantation.
Implementation Suggestions
1. Laboratory Construction Requirements
| Functional Area | Equipment Configuration | Environmental Control |
|---|---|---|
| Sample Pretreatment Area | Constant Temperature and Humidity Chamber | 23±2℃/50±10%RH |
| Optical Measurement Area | Anti-vibration Platform+LED Cold Light Source | Illumination≥1000lux |
2. Data Quality Control
It is recommended to use Minitab for statistical process control (SPC):
- Establish X-bar R control chart monitors measurement system stability
- Perform Gage R&R analysis (NDC ≥ 5)
- Regularly verify system accuracy using standard calibration blocks
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