"vitro " CNS Standards List |
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CNS 15449-2-101
2019 Edition Safe requirements for electrical for measurement, control and laboratory use ? Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment 量測、控制及實驗室使用電氣設備安全規定－第2-101 部:體外診斷(IVD)醫用設備之個別規定 |
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CNS 14393-5
2018 Edition Biological evaluation of medical devices – Part 5：Tests for in vitro cytotoxicity 醫療器材生物性評估 －第五部分：體外細胞毒性試驗 |
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CNS 15035
2018 Edition In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus 體外診斷系統－糖尿病管理時自我檢測用血糖監測系統之規定 |
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