T/KCH 002-2022 Active

Scope: This standard specifies the test method for "the external pull-out force of stents for gastric bypass". This standard applies to stents for gastric bypass in the duodenum. Such stents are mainly made of metal alloy materials. If they are coated with a membrane, it can be made of animal-derived tissues and/or high-molecular-weight materials. For non-vascular self-expanding metal stents used in interventional therapy (which can be bare stents or coated stents), their external pull-out force tests can refer to this standard. Main technical content: Gastric bypass stents belong to non-vascular self-expanding metal stents. Their implantation sites are in the duodenum and upper jejunum, which is an innovative technology in China. At present, there are no similar products applying this technology on the market in China. According to the existing standards GB/T 15812.1-2005 "Non-vascular endoscopic catheters - Part 1: General performance test methods: Appendix B - Tensile performance test methods" and GB/T 25304-2010 "Specific requirements for non-vascular self-expanding metal stents", detailed test methods are listed. This standard, on the basis of the existing standard test methods, provides a test method for the fixation of digestive tract stents at their implantation sites, and is a supplement to the standards GB/T 15812.1-2005 "Non-vascular endoscopic catheters - Part 1: General performance test methods: Appendix B - Tensile performance test methods" and GB/T 25304-2010 "Specific requirements for non-vascular self-expanding metal stents".