In the GB/T18457-2015 standard for ultra-thin wall needles, many references for ultra-thin wall data are missing. For example, in the slim puncture needles/biopsy needles/tissue treatment needles/guiding needles, in order to minimize trauma and maximize space for minimally invasive surgery, designers have caused some confusion in parameter settings when designing products.

Firstly, with regard to the ultra-long and ultra-thin wall needle tube, GB/T18457-2015 addresses three issues. 1. Although the product meets the steel toughness requirements, its use status cannot meet the needs of surgery. 2. The ultra-long and ultra-thin wall space limitation cannot meet the requirements of the scene to form the demand S-cycle. 3. There is no clear guidance on the parameter matching of material application and physical properties, and it all depends on the fuzzy state reference setting.

According to the analysis of the actual problem, in order to solve its shortcomings, we must first meet the indicators required by the registration, and then achieve the goal of product performance.

For the puncture needle tube, considering the deformation, rebound and return strength, even if it meets the parameter requirements in GB/T 18457-2015, it still cannot meet the performance requirements.

For the biopsy needle tube, considering the problem of target linearity and linear strength, even if it meets the parameter requirements in GB/T 18457-2015, there is still a problem of unsatisfactory performance.

In response to the above problems, SINOWARES proposed the following solutions: 1: According to the goals and needs of the surgical department and references to similar products, select the same materials for the design; 2: In terms of material settings, while meeting the rigid toughness requirements of the needle tube in GB/T 18457-2015, we also need to set additional parameters such as "extensibility" to meet the elasticity requirements; 3: Using the registration document as a guide for the material, try to select materials that meet special ingredients or biocompatible materials for the design. Of course, all of this is done in accordance with the certification body's guidelines.