ZIEHM IMAGING GMBH
ZIEHM IMAGING GMBH
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2023-02-16 |
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 Input8.4.3 Voltage or Charge Limitation8.6.4 Impedance and current carrying capabilities8.7 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 Withstand9.4.2. Stability and Transportability9.4.2.1 Instability in transport position9.4.2.2. Instability excluding transport position9.4.2.3 Instability from horizontal and vertical forces9.4.2.4.2 Force for propulsion9.4.2.4.3 Movement over threshold9.4.3.1 Instability from unwanted Lateral Movement9.8.2 Tensile Safety Factor11. Temperature11.6.3 Spillage11.6.5 Ingress of liquids13 abnormal operation15.4.7.1 Cord-Connected Foot Operated Control Devices15.3.2 Push Test15.3.3. Impact Test15.3.5 Rough Handling test15.4.7.1 b) mechanical strength15.4.7.2 Accidental operation of ME Equipment15.4.7.3 b) Entry of liquids | 2023-02-16 | |
MED | IEC 60601-1:2005/AMD1:2012 | 4.11 Power Input8.4.3 Voltage or Charge Limitation8.6.4 Impedance and current carrying capabilities8.7 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 Withstand9.4.2. Stability and Transportability9.4.2.1 Instability in transport position9.4.2.2. Instability excluding transport position9.4.2.3 Instability from horizontal and vertical forces9.4.2.4.2 Force for propulsion9.4.2.4.3 Movement over threshold9.4.3.1 Instability from unwanted Lateral Movement9.8.2 Tensile Safety Factor11. Temperature11.6.3 Spillage11.6.5 Ingress of liquids13 abnormal operation15.4.7.1 Cord-Connected Foot Operated Control Devices15.3.2 Push Test15.3.3. Impact Test15.3.5 Rough Handling test15.4.7.1 b) mechanical strength15.4.7.2 Accidental operation of ME Equipment15.4.7.3 b) Entry of liquids | 2023-02-16 | |
MED | IEC 60601-1:2005/AMD2:2020 | 4.11 Power Input8.4.3 Voltage or Charge Limitation8.6.4 Impedance and current carrying capabilities8.7 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 Withstand9.4.2. Stability and Transportability9.4.2.1 Instability in transport position9.4.2.2. Instability excluding transport position9.4.2.3 Instability from horizontal and vertical forces9.4.2.4.2 Force for propulsion9.4.2.4.3 Movement over threshold9.4.3.1 Instability from unwanted Lateral Movement9.8.2 Tensile Safety Factor11. Temperature11.6.3 Spillage11.6.5 Ingress of liquids13 abnormal operation15.4.7.1 Cord-Connected Foot Operated Control Devices15.3.2 Push Test15.3.3. Impact Test15.3.5 Rough Handling test15.4.7.1 b) mechanical strength15.4.7.2 Accidental operation of ME Equipment15.4.7.3 b) Entry of liquids | 2023-02-16 | |
MED | IEC 60601-1-3:2008 | 7.1 Half Value Layer7.6 First HALF-VALUE LAYER under NARROW BEAM CONDITIONS12.4 LEAKAGE RADIATION in the LOADING STATE13.4 Designated significant zones of occupancy | 2023-02-16 | |
MED | IEC 60601-1-3:2008/AMD1:2013 | 7.1 Half Value Layer7.6 First HALF-VALUE LAYER under NARROW BEAM CONDITIONS12.4 LEAKAGE RADIATION in the LOADING STATE13.4 Designated significant zones of occupancy | 2023-02-16 | |
MED | IEC 60601-1-3:2008/AMD2:2021 | 7.1 Half Value Layer7.6 First HALF-VALUE LAYER under NARROW BEAM CONDITIONS12.4 LEAKAGE RADIATION in the LOADING STATE13.4 Designated significant zones of occupancy | 2023-02-16 | |
MED | IEC 60601-2-28:2017 | 201.8.8.3 Dielectric strength | 2023-02-17 | |
MED | IEC 60601-2-28:2010 | 201.8.8.3 Dielectric strength | 2023-02-16 | |
MED | IEC 60601-2-43:2010 | 201.4.101 Recovery management201.9.2.4 Emergency stopping devices203.6.101 Reference Airkerma203.13.4 Isokermacurves | 2023-02-16 | |
MED | IEC 60601-2-43:2010/AMD1:2017 | 201.4.101 Recovery management201.9.2.4 Emergency stopping devices203.6.101 Reference Airkerma203.13.4 Isokermacurves | 2023-02-16 | |
MED | IEC 60601-2-43:2010/AMD2:2019 | 201.4.101 Recovery management201.9.2.4 Emergency stopping devices203.6.101 Reference Airkerma201.11.6.5.103 ENCLOSURES203.13.4 Isokermacurves | 2023-02-16 | |
MED | IEC 60601-2-54:2009 | 201.8.8.3 Electrical strength203.4.101.2 Percentage Ripple in constant potential high-voltage generators203.5.2.4.5.102 Test for dosimetric information203.6.3.101 Limitation of reference air kerma in radioscopy203.6.3.2.101 Reproducibility of the RADIATION output in RADIOGRAPHY203.6.3.2.102 Reproducibility, linearity and constancy of radiation output203.6.4.3.104 x-ray tube factors203.6.4.3.104.3 Accuracy of X-RAY TUBE VOLTAGE203.6.4.3.104.4 Accuracy of X-RAY TUBE CURRENT203.8.5.3 Correspondence between x-ray field and effective image reception area203.8.102.1 Beam limitation203.11.102 Attenuation of residual radiation203.13.4.101 STRAY RADIATION IN SIGNIFICANT ZONES OF OCCUPANCY | 2023-02-16 | |
MED | IEC 60601-2-54:2009/AMD1:2015 | 201.8.8.3 Electrical strength203.4.101.2 Percentage Ripple in constant potential high-voltage generators203.5.2.4.5.102 Test for dosimetric information203.6.3.101 Limitation of reference air kerma in radioscopy203.6.3.2.101 Reproducibility of the RADIATION output in RADIOGRAPHY203.6.3.2.102 Reproducibility, linearity and constancy of radiation output203.6.4.3.104 x-ray tube factors203.6.4.3.104.3 Accuracy of X-RAY TUBE VOLTAGE203.6.4.3.104.4 Accuracy of X-RAY TUBE CURRENT203.8.5.3 Correspondence between x-ray field and effective image reception area203.8.102.1 Beam limitation203.11.102 Attenuation of residual radiation203.13.4.101 STRAY RADIATION IN SIGNIFICANT ZONES OF OCCUPANCY | 2023-02-16 | |
MED | IEC 60601-2-54:2009/AMD2:2018 | 201.8.8.3 Electrical strength203.4.101.2 Percentage Ripple in constant potential high-voltage generators203.5.2.4.5.102 Test for dosimetric information203.6.3.101 Limitation of reference air kerma in radioscopy203.6.3.2.101 Reproducibility of the RADIATION output in RADIOGRAPHY203.6.3.2.102 Reproducibility, linearity and constancy of radiation output203.6.4.3.104 x-ray tube factors203.6.4.3.104.3 Accuracy of X-RAY TUBE VOLTAGE203.6.4.3.104.4 Accuracy of X-RAY TUBE CURRENT203.8.5.3 Correspondence between x-ray field and effective image reception area203.8.102.1 Beam limitation203.11.102 Attenuation of residual radiation203.13.4.101 STRAY RADIATION IN SIGNIFICANT ZONES OF OCCUPANCY | 2023-02-16 |