Planmeca Oy
Planmeca Oy
| Address(es) |
|
| Website | Not available |
| Status | WITHDRAWN |
| Acceptance date | 2022-06-14 |
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 Parts8.4.2 Limitation of Voltage, Current or Power8.4.4 Voltage Limitation (Part 2)8.5.4 Working Voltage Measurements8.6.4 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 Current8.7.4.7 c) Patient Leakage Current, Mains on I/O8.7.3 e) Non-Frequency-Weighted Leakage Current8.8.3 Dielectric Voltage Withstand9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.4.2 Stability and Transportability9.4.2.4.2 Mobile Equipment Force for Propulsion9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.6.2.1 Acoustic Energy Measurement9.8.2 Tensile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.3.3 Mechanical Strength - Dynamic Forces11 Temperature11.6.6 Cleaning and Disinfection11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.2 Impairment of Cooling13.2 Locking of Moving Parts15.3.2 Enclosure Force15.3.5 Rough Handling15.5.1.2 Transformer Short Circuit15.5.1.3 Transformer Overload | 2022-06-14 | |
MED | IEC 60601-1:2005/AMD1:2012 | 4.11 Power Input5.9.2 Determination of Accessible Parts8.4.2 Limitation of Voltage, Current or Power8.4.4 Voltage Limitation (Part 2)8.5.4 Working Voltage Measurements8.6.4 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 Current8.7.4.7 c) Patient Leakage Current, Mains on I/O8.7.3 e) Non-Frequency-Weighted Leakage Current8.8.3 Dielectric Voltage Withstand9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.4.2 Stability and Transportability9.4.2.4.2 Mobile Equipment Force for Propulsion9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.6.2.1 Acoustic Energy Measurement9.8.2 Tensile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.3.3 Mechanical Strength - Dynamic Forces11 Temperature11.6.6 Cleaning and Disinfection11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.2 Impairment of Cooling13.2 Locking of Moving Parts15.3.2 Enclosure Force15.3.5 Rough Handling15.5.1.2 Transformer Short Circuit15.5.1.3 Transformer Overload | 2022-06-14 | |
MED | IEC 60601-1:2005/AMD2:2020 | 4.11 Power Input5.9.2 Determination of Accessible Parts8.4.2 Limitation of Voltage, Current or Power8.4.4 Voltage Limitation (Part 2)8.5.4 Working Voltage Measurements8.6.4 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 Current8.7.4.7 c) Patient Leakage Current, Mains on I/O8.7.3 e) Non-Frequency-Weighted Leakage Current8.8.3 Dielectric Voltage Withstand9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.4.2 Stability and Transportability9.4.2.4.2 Mobile Equipment Force for Propulsion9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.6.2.1 Acoustic Energy Measurement9.8.2 Tensile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.3.3 Mechanical Strength - Dynamic Forces11 Temperature11.6.6 Cleaning and Disinfection11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.2 Impairment of Cooling13.2 Locking of Moving Parts15.3.2 Enclosure Force15.3.5 Rough Handling15.5.1.2 Transformer Short Circuit15.5.1.3 Transformer Overload | 2022-06-14 | |
MED | IEC 60601-1-3:2008 | Clause 7.4 Test for FILTRATION by irremovable materials Clause 7.5 Test for ADDED FILTERS and materials Clause 7.6 Test for HALF-VALUE LAYER Clause 8.5.2 FOCAL SPOT TO IMAGE RECEPTOR DISTANCEClause 12.4 LEAKAGE RADIATION in the LOADING STATEClause 12.5 LEAKAGE RADIATION when not in the LOADING STATE | 2022-06-14 | |
MED | IEC 60601-1-3:2008/AMD1:2013 | Clause 7.4 Test for FILTRATION by irremovable materials Clause 7.5 Test for ADDED FILTERS and materials Clause 7.6 Test for HALF-VALUE LAYER Clause 8.5.2 FOCAL SPOT TO IMAGE RECEPTOR DISTANCEClause 12.4 LEAKAGE RADIATION in the LOADING STATEClause 12.5 LEAKAGE RADIATION when not in the LOADING STATE | 2022-06-14 | |
MED | IEC 60601-1-3:2008/AMD2:2021 | Clause 7.4 Test for FILTRATION by irremovable materials Clause 7.5 Test for ADDED FILTERS and materials Clause 7.6 Test for HALF-VALUE LAYER Clause 8.5.2 FOCAL SPOT TO IMAGE RECEPTOR DISTANCEClause 12.4 LEAKAGE RADIATION in the LOADING STATEClause 12.5 LEAKAGE RADIATION when not in the LOADING STATE | 2022-06-14 | |
MED | IEC 60601-2-44:2009 | Clause 201.8.8.3 Dielectric strength HV test 154 kV, tube headClause 201.9.2.3.1.102 Unintentional interruptionClause 203.6.3.2 Reproducibility of the RADIATION outputClause 203.7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENTClause 203.9 FOCAL SPOT TO SKIN DISTANCEClause 203.13.1 General Clause 203.101 Emergency TERMINATION of X-RADIATIONClause 203.107 Safety measures against excessive X-RADIATIONClause 203.115 Indication and position of the TOMOGRAPHIC SECTION | 2022-06-14 | |
MED | IEC 60601-2-44:2009/AMD1:2012 | Clause 201.8.8.3 Dielectric strength HV test 154 kV, tube headClause 201.9.2.3.1.102 Unintentional interruptionClause 203.6.3.2 Reproducibility of the RADIATION outputClause 203.7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENTClause 203.9 FOCAL SPOT TO SKIN DISTANCEClause 203.13.1 General Clause 203.101 Emergency TERMINATION of X-RADIATIONClause 203.107 Safety measures against excessive X-RADIATIONClause 203.115 Indication and position of the TOMOGRAPHIC SECTION | 2022-06-14 | |
MED | IEC 60601-2-44:2009/AMD2:2016 | Clause 201.8.8.3 Dielectric strength HV test 154 kV, tube headClause 201.9.2.3.1.102 Unintentional interruptionClause 203.6.3.2 Reproducibility of the RADIATION outputClause 203.7.1 HALF-VALUE LAYERS and TOTAL FILTRATION in X-RAY EQUIPMENTClause 203.9 FOCAL SPOT TO SKIN DISTANCEClause 203.13.1 General Clause 203.101 Emergency TERMINATION of X-RADIATIONClause 203.107 Safety measures against excessive X-RADIATIONClause 203.115 Indication and position of the TOMOGRAPHIC SECTION | 2022-06-14 | |
MED | IEC 60601-2-54:2009 | 201.4.10.2 Supply MAINS for ME Equipment and ME System201.8.8.3 Dielectric Strength 201.9.2.2.6 Speed of movement203.4.101.2 PERCENTAGE RIPPLE IN CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS203.5.2.4.5.101 DOSIMETRIC INFORMATION FOR X-RAY EQUIPMENT203.6.2.1)+6.2.1.102 interlock SAFETY MEASURES AGAINST FAILURE OF NORMAL TERMINATION OF THE IRRADIATION203.6.3.2.101 REPRODUCIBILITY OF THE RADIATION OUTPUT IN RADIOGRAPHY203.6.3.2.102 A LINEARITY OF AIR KERMA OVER LIMITED INTERVALS OF LOADING FACTORS203.6.3.2.102 D REPRODUCIBILITY OF AUTOMATIC EXPOSURE CONTROLS FOR INDIRECT RADIOGRAPHY203.6.4.3.104.3 ACCURACY OF X-RAY TUBE VOLTAGE203.6.4.3.104.4 ACCURACY OF X-RAY TUBE CURRENT203.6.4.3.104.5 ACCURACY OF LOADING TIME203.6.4.3.104.6 ACCURACY OF CURRENT TIME PRODUCT203.6.4.5 DOSIMETRIC INDICATIONS203.6.5.101 DETERMINATION OF THE NOMINAL SHORTEST IRRADIATION TIME203.8.5.3 CORRESPONDENCE BETWEEN X-RAY FIELD AND IMAGE RECEPTION AREA203.8.102.1 METHODS OF BEAM LIMITATION IN X-RAY EQUIPMENT203.8.102.4 ACCURACY OF MARKED AND WRITTEN INDICATIONS203.8.102.5 INDICATION BY LIGHT FIELD-INDICATOR 203.8.102.6 ACCURACY OF INDICATION WITH A LIGHT FIELD-INDICATOR203.9 FOCAL SPOT TO SKIN DISTANCE 203.10.101 TEST FOR ATTENUATION EQUIVALENT203.11.102 TEST FOR ATTENUATION OF RESIDUAL RADIATION | 2022-06-14 | |
MED | IEC 60601-2-54:2009/AMD1:2015 | 201.4.10.2 Supply MAINS for ME Equipment and ME System201.8.8.3 Dielectric Strength 201.9.2.2.6 Speed of movement203.4.101.2 PERCENTAGE RIPPLE IN CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS203.5.2.4.5.101 DOSIMETRIC INFORMATION FOR X-RAY EQUIPMENT203.6.2.1)+6.2.1.102 interlock SAFETY MEASURES AGAINST FAILURE OF NORMAL TERMINATION OF THE IRRADIATION203.6.3.2.101 REPRODUCIBILITY OF THE RADIATION OUTPUT IN RADIOGRAPHY203.6.3.2.102 A LINEARITY OF AIR KERMA OVER LIMITED INTERVALS OF LOADING FACTORS203.6.3.2.102 D REPRODUCIBILITY OF AUTOMATIC EXPOSURE CONTROLS FOR INDIRECT RADIOGRAPHY203.6.4.3.104.3 ACCURACY OF X-RAY TUBE VOLTAGE203.6.4.3.104.4 ACCURACY OF X-RAY TUBE CURRENT203.6.4.3.104.5 ACCURACY OF LOADING TIME203.6.4.3.104.6 ACCURACY OF CURRENT TIME PRODUCT203.6.4.5 DOSIMETRIC INDICATIONS203.6.5.101 DETERMINATION OF THE NOMINAL SHORTEST IRRADIATION TIME203.8.5.3 CORRESPONDENCE BETWEEN X-RAY FIELD AND IMAGE RECEPTION AREA203.8.102.1 METHODS OF BEAM LIMITATION IN X-RAY EQUIPMENT203.8.102.4 ACCURACY OF MARKED AND WRITTEN INDICATIONS203.8.102.5 INDICATION BY LIGHT FIELD-INDICATOR 203.8.102.6 ACCURACY OF INDICATION WITH A LIGHT FIELD-INDICATOR203.9 FOCAL SPOT TO SKIN DISTANCE 203.10.101 TEST FOR ATTENUATION EQUIVALENT203.11.102 TEST FOR ATTENUATION OF RESIDUAL RADIATION | 2022-06-14 | |
MED | IEC 60601-2-54:2009/AMD2:2018 | 201.4.10.2 Supply MAINS for ME Equipment and ME System201.8.8.3 Dielectric Strength 201.9.2.2.6 Speed of movement203.4.101.2 PERCENTAGE RIPPLE IN CONSTANT POTENTIAL HIGH-VOLTAGE GENERATORS203.5.2.4.5.101 DOSIMETRIC INFORMATION FOR X-RAY EQUIPMENT203.6.2.1)+6.2.1.102 interlock SAFETY MEASURES AGAINST FAILURE OF NORMAL TERMINATION OF THE IRRADIATION203.6.3.2.101 REPRODUCIBILITY OF THE RADIATION OUTPUT IN RADIOGRAPHY203.6.3.2.102 A LINEARITY OF AIR KERMA OVER LIMITED INTERVALS OF LOADING FACTORS203.6.3.2.102 D REPRODUCIBILITY OF AUTOMATIC EXPOSURE CONTROLS FOR INDIRECT RADIOGRAPHY203.6.4.3.104.3 ACCURACY OF X-RAY TUBE VOLTAGE203.6.4.3.104.4 ACCURACY OF X-RAY TUBE CURRENT203.6.4.3.104.5 ACCURACY OF LOADING TIME203.6.4.3.104.6 ACCURACY OF CURRENT TIME PRODUCT203.6.4.5 DOSIMETRIC INDICATIONS203.6.5.101 DETERMINATION OF THE NOMINAL SHORTEST IRRADIATION TIME203.8.5.3 CORRESPONDENCE BETWEEN X-RAY FIELD AND IMAGE RECEPTION AREA203.8.102.1 METHODS OF BEAM LIMITATION IN X-RAY EQUIPMENT203.8.102.4 ACCURACY OF MARKED AND WRITTEN INDICATIONS203.8.102.5 INDICATION BY LIGHT FIELD-INDICATOR 203.8.102.6 ACCURACY OF INDICATION WITH A LIGHT FIELD-INDICATOR203.9 FOCAL SPOT TO SKIN DISTANCE 203.10.101 TEST FOR ATTENUATION EQUIVALENT203.11.102 TEST FOR ATTENUATION OF RESIDUAL RADIATION | 2022-06-14 |