医疗器械测试标准国内外标准大全
名称/Title | /international standards | 国内标准/National standards |
测量、控制和试验室用电气设备的安全要求 Electrical Equipment ForMeasurement, | IEC/EN 61010-1 | GB4793.1 |
测量、控制和试验室用电气设备的安全要求 Safety requirements for electricalequipment for measurement, control andlaboratory use –Part 2-101:Particular requirements for in vitro diagnostic (IVD)medicalequipm |
IEC/EN 61010-2-101
| YY 0648 |
测量、控制和实验室用电气设备的安全要求:实验室用分析和其他目的自动和半自动设备的特殊要求 Safety requirements for electricalequipment for measurement, control and laboratory use – Part 081: Particular requirements for automatic and semiautomaticlaboratory equipment for analysis and other purposes |
IEC/EN 61010-2-081
| GB4793.9 GB/T42125.14 |
测量、控制和实验室用的电设备 电磁兼容性要求 第1部分:通用要求 Electrical equipment formeasurement, control and laboratory use - EMC requirements - Part1: General requirements |
IEC/EN 61326-1
| GB/T 18268.1 |
测量、控制和实验室用电设备.电磁兼容性(EMC)的要求.特殊要求.实验室诊断 Electrical equipment formeasurement, control and laboratory use - EMC requirements - Part2-6: Particular requirements - In vitro diagnostic (IVD) medicalequipment |
IEC/EN 61326-2-6
| GB/T18268.26 |