| 1. | Biological evaluation of medical devices - part 1 : evaluation and testing
医疗器械生物学评价第1部分:评价与试验 |
| 2. | Biological evaluation of medical devices - part 2 : animal welfare requirements
医疗器械生物学评价第2部分:动物保护要求 |
| 3. | Biological evaluation of medical devices - part 11 : tests for systemic toxicity
医疗器械生物学评价第11部分：全身毒性试验 |
| 4. | Biological evaluation of medical devices - part 5 : test for in vitro cytotoxicity
医疗器械生物学评价第5部分:体外细胞毒性试验 |
| 5. | Biological evaluation of medical devices - part 7 : ethylene oxide sterilization residuals
医疗器械生物学评价第7部分:环氧乙烷灭菌残留量 |
| 6. | Biological evaluation of medical devices - part 6 : tests for local effects after implantation
医疗器械生物学评价第6部分：植入后局部反应试验 |
| 7. | Biological evaluation of medical devices - part 12 : sample preparation and reference materials
医疗器械生物学评价第12部分：样品制备与参照样品 |
| 8. | Biological evaluation of medical devices - part 10 : tests for irritation and delayed - type hypersensitivity
医疗器械生物学评价第10部分：刺激与迟发型超敏反应试验 |
| 9. | Biological evaluation of medical devices - part 17 : establishment of allowable limits for leachable substances
医疗器械生物学评价第17部分：可沥滤物允许限量的建立 |
