ESAOTE S.p.A.
ESAOTE S.p.A.
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2023-10-17 |
Further information
Stage | Country | Name |
|---|---|---|
2 | 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 Input5.7 – Humidity Conditioning5.9.2 – Determination of Accessible Parts7.1.2 – Legibility of Markings7.1.3 – Durability of Markings7.2.6 -Voltage Mismatch8.1 b - Shorting One MOP8.2.2 - Incorrect Polarity8.4.2 - Limitation of Voltage, Current or Power8.4.3 - Voltage or Charge Limitation8.5.4 - Working Voltage Measurements8.6.4 – Impedance and Current Carrying Capability8.7 – Leakage Current Tests8.8.3 – Dielectric Voltage Withstand8.8.4.1 – Ball Pressure8.9.2 - Short Circuiting in Lieu of Spacings8.9.3.2 - Thermal cycling tests on one sample of insulating compound forming solid insulation between conductive parts8.9.3.3 - Thermal cycling tests on one sample of cemented joint with other insulating part8.11.3.5 - CORD ANCHORAGES8.11.3.6 - Cord guard9.2.3.2 - Over-travel End Stop Test9.4 – Stability and Transportability | 2023-10-17 | |
MED | IEC 60601-1:2005/AMD1:2012 | 4.11 – Power Input5.7 – Humidity Conditioning5.9.2 – Determination of Accessible Parts7.1.2 – Legibility of Markings7.1.3 – Durability of Markings7.2.6 -Voltage Mismatch8.1 b - Shorting One MOP8.2.2 - Incorrect Polarity8.4.2 - Limitation of Voltage, Current or Power8.4.3 - Voltage or Charge Limitation8.5.4 - Working Voltage Measurements8.6.4 – Impedance and Current Carrying Capability8.7 – Leakage Current Tests8.8.3 – Dielectric Voltage Withstand8.8.4.1 – Ball Pressure8.9.2 - Short Circuiting in Lieu of Spacings8.9.3.2 - Thermal cycling tests on one sample of insulating compound forming solid insulation between conductive parts8.9.3.3 - Thermal cycling tests on one sample of cemented joint with other insulating part8.11.3.5 - CORD ANCHORAGES8.11.3.6 - Cord guard9.2.3.2 - Over-travel End Stop Test9.4 – Stability and Transportability | 2023-10-17 | |
MED | IEC 60601-1:2005/AMD2:2020 | 4.11 – Power Input5.7 – Humidity Conditioning5.9.2 – Determination of Accessible Parts7.1.2 – Legibility of Markings7.1.3 – Durability of Markings7.2.6 -Voltage Mismatch8.1 b - Shorting One MOP8.2.2 - Incorrect Polarity8.4.2 - Limitation of Voltage, Current or Power8.4.3 - Voltage or Charge Limitation8.5.4 - Working Voltage Measurements8.6.4 – Impedance and Current Carrying Capability8.7 – Leakage Current Tests8.8.3 – Dielectric Voltage Withstand8.8.4.1 – Ball Pressure8.9.2 - Short Circuiting in Lieu of Spacings8.9.3.2 - Thermal cycling tests on one sample of insulating compound forming solid insulation between conductive parts8.9.3.3 - Thermal cycling tests on one sample of cemented joint with other insulating part8.11.3.5 - CORD ANCHORAGES8.11.3.6 - Cord guard9.2.3.2 - Over-travel End Stop Test9.4 – Stability and Transportability | 2023-10-17 | |
MED | IEC 60601-2-37:2007 | 201.8 Protection against again ME equipment201.8.7.4.7 Measurement of patient leakage current201.8.7.4.8 Measurement of patient auxiliary current201.8.8.3 Dielectric strength201.8.9.3.4 Thermal Cycling201.8.10.4 Cord-connected hand held parts and cord-connected foot-operated control device201.10.101 Ultrasonic energy201.11.6.5 Ingress of water or particular matter into ME equipment and ME system | 2023-10-17 | |
MED | IEC 60601-2-37:2007/AMD1:2015 | 201.8 Protection against again ME equipment201.8.7.4.7 Measurement of patient leakage current201.8.7.4.8 Measurement of patient auxiliary current201.8.8.3 Dielectric strength201.8.9.3.4 Thermal Cycling201.8.10.4 Cord-connected hand held parts and cord-connected foot-operated control device201.10.101 Ultrasonic energy201.11.6.5 Ingress of water or particular matter into ME equipment and ME system | 2023-10-17 |