GB/T 39381.1-2020
ActiveCardiovascular implants—Vascular device-drug combination products—Part 1：General requirements
心血管植入物 血管药械组合产品 第1部分：通用要求
Application Summary AI generated
This standard specifies general requirements for vascular device-drug combination products used as cardiovascular implants, covering aspects such as design, materials, manufacturing, sterilization, and biocompatibility. It applies to products that integrate a medical device (e.g., stent, balloon catheter) with a pharmaceutical component (e.g., antiproliferative drug) for treating vascular diseases. The standard is used by manufacturers and regulatory bodies in China to ensure safety, performance, and quality control during development and testing of these combination products.
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