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| Chinese National Standard Category: Extracorporeal circulation, artificial organ and prosthesis device |
| English Title: | Biological evaluation of medical devices—Measurement of shed and released nanoparticles—Particle tracking analysis |
| Chinese Title: | 医疗器械生物学评价 纳米颗粒脱落和释放测量 颗粒跟踪分析法 |
| Standard No.: | GB/T 46147-2025 |
| Category No.: | C45 |
| Issued by: | SAMR; SAC |
| Issued on: | 2025-8-29 |
| Implemented on: | 2026-9-1 |
| Status: | to be valid |
| Superseded by: | |
| Superseded on: | |
| Abolished on: | |
| Superseding: | |
| Word Count: | 7500 words |
| Similar Standards: |
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