额定爆裂压力 & 泄漏测试

Rated burst pressure (RBP) and leak test methods evaluate the safety and efficacy of medical devices that contain liquid or air during use. The devices are routinely tested to failure at worst-case conditions to ensure they are compliant and fit for use in the field.

im体育APP specializes in medical device burst and leak testing for catheters, 气球, 阀门, 医疗包, 油管, 和连接器. 

In addition to leak and burst testing, pressure and flow rate testing provide product performance data such as 乏力, inflation and deflation time, and compliance determination. 

Rated burst pressure testing

im体育APP offers rated burst pressure testing at low (up to 100 psi) or high (up to 1000 psi) pressures to characterize devices such as 气球 or catheter bodies. 对于这些方法, complete catheters or subassemblies with the balloon mounted on the catheter are used to measure rated burst pressure, the pressure at which 99% of the 气球 can survive with 95% confidence. 破裂, 泄漏, and pressure loss are recorded and failure modes are noted to characterize the 气球.   

另外, we test non-stented endovascular grafts and vascular prostheses for pressurized burst strength per ISO 7198. Pressurized burst strength is measured by either directly filling the device with fluid or by using a balloon distention apparatus. 进水压力, 泄漏, and compliance are common tests that are often performed for vascular grafts.

泄漏测试和检测 

Leakage tests reveal any manufacturing defects in fluid management systems by using air or liquid flow through a variety of components, 包括连接器, 通风配件, 导管尖端密封. Our advanced testing equipment operates with either air or liquid medium to assess 泄漏. 

Our laboratories are equipped with both low (up to 100 psi) and high (up to 1000 psi) pressure instruments to collect highly accurate test data. We also provide custom testing which allows for programmable steps where the parameters of each sequence are tailored to the device and its clinical indication.

Pressure and flow rate testing

Our medical device experts perform pressure testing on balloon catheters to assess balloon 乏力. During a balloon catheter pressure test, the device is inflated to RBP, the pressure is held for 30 seconds (or other indicated time), 气球瘪了, and then the process is repeated for 20 cycles. 

Balloon or endovascular graft compliance is a function of the pressure-diameter relationship for a given device. We utilize balloon compliance charts for proper catheter size selection to fit the target vasculature site. Balloon inflation and deflation times are critical product specifications as they control how long a vessel might be occluded by the balloon and blood flow is obstructed. 

Contrast media flow rate testing for catheters is typically performed at both maximum burst pressures and pressures catheters experience during clinical use. 

For more information about our rated burst pressure or leak testing, 立即im体育APP.