Trumpf Medizin Systeme GmbH + Co. KG
Trumpf Medizin Systeme GmbH + Co. KG
| Address(es) |
|
| Website | Not available |
| Status | WITHDRAWN |
| Acceptance date | 2012-02-15 |
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 Limitation of voltage, current or energy8.5.4 Working voltage measurements8.6.4a Impedance and current-carrying capability8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS8.8 Insulation8.9 CREEPAGE DISTANCES and AIR CLEARANCES9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME Systems9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops9.4 Instability Hazards9.7 Hydrostatic Pressure Test9.8.2 TENSILE SAFETY FACTOR11.1 Excessive temperatures in ME EQUIPMENT11.6.4 Leakage11.6.6 Cleaning and Disinfection Test11.8 Interruption of the power supply / SUPPLY MAINS to ME Equipment13 HAZARDOUS SITUATIONS and fault conditions for ME equipment13.1.2 Power Availability13.2 Lock of moving parts15.3 Mechanical strength16 LEAKAGE CURRENTS (ME SYSTEM) | 2019-04-08 | |
MED | IEC 60601-1:2005/AMD1:2012 | 4.11 Power input5.9.2 Determination of Accessible Parts8.4 Limitation of voltage, current or energy8.5.4 Working voltage measurements8.6.4a Impedance and current-carrying capability8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS8.8 Insulation8.9 CREEPAGE DISTANCES and AIR CLEARANCES9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME Systems9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops9.4 Instability Hazards9.7 Hydrostatic Pressure Test9.8.2 TENSILE SAFETY FACTOR11.1 Excessive temperatures in ME EQUIPMENT11.6.4 Leakage11.6.6 Cleaning and Disinfection Test11.8 Interruption of the power supply / SUPPLY MAINS to ME Equipment13 HAZARDOUS SITUATIONS and fault conditions for ME equipment13.1.2 Power Availability13.2 Lock of moving parts15.3 Mechanical strength16 LEAKAGE CURRENTS (ME SYSTEM) | 2019-04-08 | |
MED | IEC 60601-1:2005/AMD2:2020 | 4.11 Power input5.9.2 Determination of Accessible Parts8.4 Limitation of voltage, current or energy8.5.4 Working voltage measurements8.6.4a Impedance and current-carrying capability8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS8.8 Insulation8.9 CREEPAGE DISTANCES and AIR CLEARANCES9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME Systems9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops9.4 Instability Hazards9.7 Hydrostatic Pressure Test9.8.2 TENSILE SAFETY FACTOR11.1 Excessive temperatures in ME EQUIPMENT11.6.4 Leakage11.6.6 Cleaning and Disinfection Test11.8 Interruption of the power supply / SUPPLY MAINS to ME Equipment13 HAZARDOUS SITUATIONS and fault conditions for ME equipment13.1.2 Power Availability13.2 Lock of moving parts15.3 Mechanical strength16 LEAKAGE CURRENTS (ME SYSTEM) | 2022-07-25 | |
MED | IEC 60601-2-41:2021 | 201.9.4 Instability Hazards201.10.5 a) Central Illuminanceb) MAXIMUM CENTRAL ILLUMINANCE201.10.5.102.2 a) Light Field Diameter d 10b) Diameter d50201.10.5.102.3 a) Remaining Illuminance with one maskb) Remaining illuminance with two masksc) Remaining illuminance with simulated cavityd) Remaining illuminance with simulated cavity and one maske) Remaining illuminance with simulated cavity and two masks201.10.5.102.4 Depth of Illumination201.10.5.103 Spectral distribution of visible radiation201.10.6 Infrared radiation201.10.7 Ultraviolet Radiation201.10.101.1 Irradiance201.10.101.2 Radiance201.12.1.102.4 a) Stability of the light sourceb) Lamp failure201.13.1.101 HAZARDOUS SITUATIONS for SINGLE FAULT SAFE equipment | 2022-07-25 | |
MED | IEC 60601-2-41:2009 | 201.9.4 Instability Hazards201.10.7 Ultraviolet Radiation201.12.1.102.1.3 a) Central Illuminanceb) Light Field Diameter d 10c) Diameter d50d) Remaining Illuminance with one maske) Remaining illuminance with two masksf) Remaining illuminance with tubeg) Remaining illuminance with tube and one maskh) Remaining illuminance with tube and two masksi) Depth of Illumination201.12.1.102.2 Spectral Characteristics (Colour Rendering Index Ra, Colour Temperature)201.12.1.102.3 Temperature rise in the lighted surface (Total Irradiance)201.12.1.102.4 a) Stability of the light sourceb) Lamp failure201.13.1.101 Hazardous Situations for Fail Safe Equipment | 2019-04-08 | |
MED | IEC 60601-2-41:2009/AMD1:2013 | 201.9.4 Instability Hazards201.10.7 Ultraviolet Radiation201.12.1.102.1.3 a) Central Illuminanceb) Light Field Diameter d 10c) Diameter d50d) Remaining Illuminance with one maske) Remaining illuminance with two masksf) Remaining illuminance with tubeg) Remaining illuminance with tube and one maskh) Remaining illuminance with tube and two masksi) Depth of Illumination201.12.1.102.2 Spectral Characteristics (Colour Rendering Index Ra, Colour Temperature)201.12.1.102.3 Temperature rise in the lighted surface (Total Irradiance)201.12.1.102.4 a) Stability of the light sourceb) Lamp failure201.13.1.101 Hazardous Situations for Fail Safe Equipment | 2019-04-08 | |
MED | IEC 60601-2-46:2016 | 201.4.7 SINGLE FAULT CONDITION for OPERATING TABLES201.8.6.7 POTENTIAL EQUALIZATION CONDUCTOR201.9 Protection against MECHANICAL HAZARDS of OPERATING TABLES and ME SYSTEMS201.9.2.3.1 Unintended movement201.9.4.2.2 Instability excluding transport position201.9.4.2.4.3 Movement over a threshold201.9.4.3.1 Instability in transport position201.9.8 MECHANICAL HAZARDS associated with support systems201.9.8.1 General201.9.8.2 TENSILE SAFETY FACTOR201.9.8.3.2 Static forces due to loading from persons201.9.8.3.3 Dynamic forces due to loading from persons201.10 Protection against unwanted and excessive radiation HAZARDS201.11 Protection against excessive temperatures and other HAZARDS201.11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the OPERATING TABLES201.11.6.5 Ingress of water or particulate matter into OPERATING TABLES and ME SYSTEMS201.11.8 Interruption of the power supply/SUPPLY MAINS to OPERATING TABLES201.12 Accuracy of controls and instruments and protection against hazardous outputs201.13 HAZARDOUS SITUATIONS and fault conditions for OPERATING TABLES201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)201.15 Construction of OPERATING TABLES201.15.3.5 Rough handling test201.15.4.7.2 Accidental operation of OPERATING TABLES201.15.4.7.2.101 Inadvertent operation201.16 ME SYSTEMS202 Electromagnetic disturbances – Requirements and tests202.8 Electromagnetic IMMUNITY requirements for OPERATING TABLES and ME SYSTEMS202.8.101 IMMUNITY pass/fail criteria202.8.102 IMMUNITY to HF SURGICAL EQUIPMENT EMISSIONS | 2019-04-08 |