T/JSAS 033-2022 vertebral dilator balloon-tipped guidewire
T/JSAS 033-2022 vertebral dilator balloon-tipped guidewire
Basic Information
Scope
Scope: This document specifies the product classification, technical requirements, test methods, inspection rules, and packaging, marking, transportation, and storage of vertebral expansion balloon catheters. This document applies to vertebral expansion balloon catheters; Main technical content: 5.3 The two seats of the Y-shaped connector should be inner conical seats, which shall comply with the requirements of GB/T 1962.2. 5.4 The mating performance between the support wire nut and the catheter locking joint should be flexible and capable of locking, without any jamming or slippage. 5.5 Connection firmness 5.5.1 The connection between the support wire and its nut should be firmly connected. When a force of 15N is applied to the connection point, it should not come loose or break. 5.5.2 The connection between the outer balloon catheter and the Y-shaped connector should be firmly connected. When a force of 15N is applied to the connection point, it should not come loose or break. 5.5.3 The connection between the outer balloon catheter and the balloon should be firmly connected. When a force of 15N is applied to the connection point, it should not come loose or break. 5.6 Radiographic detectability The radiographic detectable ring on the balloon catheter should be detectable by X-rays. According to the measurement of optical density in YY/T