GB/T 39381.1-2020 in English
VALIDCardiovascular implants—Vascular device-drug combination products—Part 1:General requirements
- Issued on:2020-11-19
- Implemented on:2021-12-01
- File Format:PDF
- Delivery:Via email within 5 business days
$418.00
《GB/T 39381.1-2020心血管植入物 血管药械组合产品 第1部分：通用要求》由TC110（全国外科植入物和矫形器械标准化技术委员会）归口，TC110SC2（全国外科植入物和矫形器械标准化技术委员会心血管植入物分会）执行，主管部门为国家药品监督管理局。
Introduction
Analysis of the core content of the standard
| Technical dimensions | Key requirements | Test methods |
|---|---|---|
| Drug content consistency | Intra-batch difference ≤15% | HPLC/UV spectrophotometry |
| Drug release characteristics | 80% drug release time control | In vitro dissolution test |
| Biocompatibility | In compliance with GB/T 16886 series | Cytotoxicity/sensitization test |
Technology Evolution Background
This standard adopts ISO 12417-1:2015, adjusts the reference document system according to China's regulatory requirements, and adds special requirements such as solvent residue. The technology of vascular drug-device combination products has evolved from simple mechanical treatment to targeted drug delivery, which requires a balance between the mechanical properties of the device and the controlled release characteristics of the drug.
Implementation recommendations
Case: In the development of drug-eluting stents, it is recommended to use accelerated aging tests (40℃/75%RH) to verify the stability of the coating. At the same time, the following should be carried out:
- Microscopic examination of coating integrity after stent expansion
- 28-day animal experiment to evaluate the degree of endothelialization
- LC-MS detection of degradation products
Special considerations
For products containing degradable matrices, additional attention should be paid to:
- Matching of degradation rate with drug release curve
- Biocompatibility of degradation products
- Effect of sterilization method on material properties (e.g., γ irradiation may change polymer crystallinity)
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