WIPRO GE HEALTHCARE PRIVATE LIMITED
WIPRO GE HEALTHCARE PRIVATE LIMITED
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2021-05-06 |
Further information
Stage | Country | Name |
|---|---|---|
1 | Denmark |
LEGEND: Scope Limitations
- RA : Audio amplifiers with audio power > 0,5 Watts excluded
- RC : Apparatus with connection(s) to a cable distribution system excluded
- RSH : Shredders excluded
- RT : Apparatus with connection(s) to a telecommunication network excluded
- RV : CRT (cathode ray tubes)/ picture tubes, plasma/LCD or other video apparatus excluded
- ROUT : Equipment intended for installation outdoors excluded
- RWPT : Wireless power transmitter excluded
Category | Name | Tests/Clauses | Acceptance Date | Responsible National Certification Body |
|---|---|---|---|---|
MED | IEC 60601-1:2005 | 4.11: Power Input5.9.2 Determination of Accessible Parts7.1.2 Legibility of Markings7.1.3 Durability of Markings8.6.4 a Impedance and Current Carrying Capability8.7 Leakage Current Tests8.7.4.5 Earth Leakage Current8.7.4.6 Touch Leakage Current8.7.4.7 a) Patient Leakage Current8.8.3 Dielectric Voltage Withstand8.11.4.2 Arrangement of Mains Terminal8.11.4.3 Fixing of Mains Terminal9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.6.2.1 Acoustic Energy Measurement9.8.3.1 Mechanical Strength - Patient Support System11 Temperature11.6.3 Spillage11.6.6 Cleaning and Disinfection11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.2 Impairment of Cooling13.2 Locking of Moving Parts15.3.2 Enclosure Force15.3.3 Enclosure Impact | 2021-05-06 | |
MED | IEC 60601-1:2005/AMD1:2012 | 4.11: Power Input5.9.2 Determination of Accessible Parts7.1.2 Legibility of Markings7.1.3 Durability of Markings8.6.4 a Impedance and Current Carrying Capability8.7 Leakage Current Tests8.7.4.5 Earth Leakage Current8.7.4.6 Touch Leakage Current8.7.4.7 a) Patient Leakage Current8.8.3 Dielectric Voltage Withstand8.11.4.2 Arrangement of Mains Terminal8.11.4.3 Fixing of Mains Terminal9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.6.2.1 Acoustic Energy Measurement9.8.3.1 Mechanical Strength - Patient Support System11 Temperature11.6.3 Spillage11.6.6 Cleaning and Disinfection11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.2 Impairment of Cooling13.2 Locking of Moving Parts15.3.2 Enclosure Force15.3.3 Enclosure Impact | 2021-05-06 | |
MED | IEC 60601-1-3:2008 | 7.1 A: Measured first half-value layer for all configurations in normal use12.4 Measured leakage radiation in the loading state13.6A Stray radiation of X-ray equipment | 2021-05-06 | |
MED | IEC 60601-1-3:2008/AMD1:2013 | 7.1 A: Measured first half-value layer for all configurations in normal use12.4 Measured leakage radiation in the loading state13.6A Stray radiation of X-ray equipment | 2021-05-06 | |
MED | IEC 60601-2-44:2009 | 201.8.4.101 Limitation of high voltage to the NOMINAL X-RAY TUBE VOLTAGE201.8.8.3 Dielectric strength203.7.6Measurement of the first half value layer at the system ISOCENTRE under NARROW BEAM CONDITIONS for all selectablevalues of the X-ray Tube voltage203.109.1 Measurement of the CDTI100 | 2021-05-06 | |
MED | IEC 60601-2-44:2009/AMD1:2012 | 201.8.4.101 Limitation of high voltage to the NOMINAL X-RAY TUBE VOLTAGE201.8.8.3 Dielectric strength203.7.6Measurement of the first half value layer at the system ISOCENTRE under NARROW BEAM CONDITIONS for all selectablevalues of the X-ray Tube voltage203.109.1 Measurement of the CDTI100 | 2021-05-06 | |
MED | IEC 60601-2-44:2009/AMD2:2016 | 201.8.4.101 Limitation of high voltage to the NOMINAL X-RAY TUBE VOLTAGE201.8.8.3 Dielectric strength203.7.6Measurement of the first half value layer at the system ISOCENTRE under NARROW BEAM CONDITIONS for all selectablevalues of the X-ray Tube voltage203.109.1 Measurement of the CDTI100 | 2021-05-06 |