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 Test | 3th ed criteria | 4th ed criteria | Enhanced 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) 61000-4-5 | 2kV common mode, 1kV differential on AC lines (minimum 5 surges at each phase angle) | 500V,1kV,2kV common mode, 500V,1kV differential on AC | 500V,1kV,2kV,4kV common mode, 500V,1kV,2KV differential mode on AC input lines # |
Conducted RF 61000-4-6 | 3Vrms, 0.15-80MHz on AC input | 3Vrms, 0.15-80MHz on AC input | Same as 4th ed Criteria |
Dips and Dropouts 61000-4-11 | Dip to 40% for 5 cycles (100 ms) Dip to 70% for 25 cycles (500ms) Dropout to 5% for 10 ms Interrupt >95% for 5 sec | Dip 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 |