IEC60601-1-2 第四版新的医疗EMC标准


IEC60601-1-2 第四版新的医疗EMC标准

60601-1的EMC部分60601-1-2现在是第三版本。但从2017年4月开始,新的认证或重新认证医疗器械,需要满足更严格的第四版标准。所以很多医疗器械制造商现在就倾向于使用符合第4版EMC的设计。 EMC标准包括辐射和干扰两部分,第四版的辐射部分和第三部基本一致,不过要注意的是辐射标准是CISPR11 B级(传导和辐射)和61000-3-2(谐波)B级。

下列表格列举了第三版和第四版的一些差别,同时标注了Globtek新一代产品GTM96系列电源产品在该规格上的参数。 美国FDA设了转换日期为2017年4月1日,下面是他们网站上面的标准: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32630

60601-1-2 Immunity Test Level

Immunity Test3th ed criteria4th ed criteriaEnhanced GT EL6 GTM96XXX Family Product Capability
ESD
61000-4-2
6KV Contact
8KV Air
8KV Contact
15KV Air
10KV Contact
18KV Air
Radiated RF
61000-4-3
3V/m, 80-2500MHz, General Medical Equip
10V/m, 80-2500MHz, Life Support Equip
3V/m, 80-2500MHz, Professional Healthcare Facility
10V/m, 80-2500MHz, Home Healthcare Environment
Same as 4th ed Criteria
EFT
61000-4-4
2kV on AC input, 5KHz Repetition
3x -- to Line, Neutral and Earth
2kV on AC input, 100KHz Repetition
3x -- to Line, Neutral and Earth
4kV on AC input, 100KHz Repetition
3x -- to Line, Neutral and Earth
Surge (Lightning) 61000-4-52kV common mode, 1kV differential on AC lines (minimum 5 surges at each phase angle)500V,1kV,2kV common mode, 500V,1kV differential on AC500V,1kV,2kV,4kV common mode, 500V,1kV,2KV differential mode on AC input lines #
Conducted RF 61000-4-63Vrms, 0.15-80MHz on AC input3Vrms, 0.15-80MHz on AC inputSame as 4th ed Criteria
Dips and Dropouts 61000-4-11Dip to 40% for 5 cycles (100 ms) Dip to 70% for 25 cycles (500ms) Dropout to 5% for 10 ms Interrupt >95% for 5 secDip to 0% for 1 cycles @ 0°phase angle Dip to 70% for 25/30 cycles @ 0° phase angle Dropout to 0% for 0.5 cycles @ 0°, 45°, 90°, 135° , 180°, 225°, 270° & 315° phase angles Interrupt 100% for 250/300 cycles-Same as 4th ed Criteria
# GTM96060 Enhanced Surge capability limited to 1.5kV for differential mode

GlobTek products compliant with IEC 60601-1-2 4th edition:

问询