1
00:00:00,000 --> 00:00:03,351
为确保各技术指标在注册检测中顺利通过

2
00:00:03,351 --> 00:00:06,673
整测针对超声刀和电刀相关标准反复推敲

3
00:00:06,672 --> 00:00:09,411
安全近六十个测试项目反复论证

4
00:00:09,411 --> 00:00:10,950
临界项反复整改

5
00:00:10,950 --> 00:00:13,735
EMC在暗室使用条件紧张的情况下

6
00:00:13,735 --> 00:00:15,287
协调内外部资源

7
00:00:15,287 --> 00:00:17,571
确保 R E 超标整改项的充分验证

8
00:00:17,569 --> 00:00:19,467
注册检测团队紧而有序

9
00:00:19,467 --> 00:00:21,365
的展开送检前各项测试

10
00:00:21,365 --> 00:00:24,141
严格保证送出的每一个样品都满足预期

11
00:00:24,339 --> 00:00:26,165
作为超声刀新标实施后的

12
00:00:26,165 --> 00:00:28,821
第一个检测导出的输出声功率的厂家

13
00:00:28,821 --> 00:00:30,113
我们的测试系统

14
00:00:30,112 --> 00:00:31,867
测试方法和输出结果

15
00:00:31,867 --> 00:00:33,604
获得了检测老师的高度认可

16
00:00:33,603 --> 00:00:36,574
完成了对上海所这个指标测试方法的建立

17
00:00:36,574 --> 00:00:38,701
为行业内后续测试提供了指导

18
00:00:38,898 --> 00:00:40,060
生物学上

19
00:00:40,060 --> 00:00:41,612
突破光典和竞品较为

20
00:00:41,612 --> 00:00:43,680
严苛的十微克每克环残限制

21
00:00:43,679 --> 00:00:46,901
采用平均日剂量不超过四毫克的全新方法

22
00:00:46,901 --> 00:00:48,399
支持了注册获证

23
00:00:48,399 --> 00:00:52,167
也大大缩短无菌刀头EO灭菌后解析时间

24
00:00:52,167 --> 00:00:53,577
降低了生产成本

25
00:00:53,776 --> 00:00:55,263
2022年3月

26
00:00:55,263 --> 00:00:56,849
上海因疫情封城

27
00:00:56,849 --> 00:00:58,694
注册检测团快速响应

28
00:00:58,694 --> 00:00:59,976
提前识别风险

29
00:00:59,976 --> 00:01:01,667
抢在封城的前一刻

30
00:01:01,667 --> 00:01:03,831
有惊无险的拿到了注册检测报告

31
00:01:03,829 --> 00:01:06,764
成功避免了疫情封城对项目注册的冲击

32
00:01:06,963 --> 00:01:08,356
产品首次注册

33
00:01:08,356 --> 00:01:09,107
时间紧

34
00:01:09,107 --> 00:01:10,015
疫情严重

35
00:01:10,015 --> 00:01:11,378
检测工作量大

36
00:01:11,378 --> 00:01:12,865
在这种高压背景下

37
00:01:12,866 --> 00:01:15,809
注册检测团队以两个月的极限周期

38
00:01:15,809 --> 00:01:17,413
高效完成检测工作

39
00:01:17,413 --> 00:01:19,512
为注册递交争取了充足的时间

40
00:01:19,511 --> 00:01:20,506
.