GE Healthcare Austria GmbH & Co OG
GE Healthcare Austria GmbH & Co OG
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2012-03-21 |
Further information
Stage | Country | Name |
|---|---|---|
3 | Germany |
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 | accepted clauses:4.11 Power input5.3 Ambient temperature, humidity, atmospheric pressure5.7 Humidity preconditioning treatment5.9 Determination of applied parts and accessible parts 7.1.2 Legibility of markings7.1.3 Durability of markings8.4.2 ACCESSIBLE PARTS and APPLIED PARTS8.5 Separation of parts8.7 Leakage currents and patient auxiliary currents 8.8 Insulation (without 8.8.4.1 and 8.8.4.2)8.9 Creepage distances and air clearances 8.10 Components and wiring9.2 Mechanical hazards associated with moving parts9.3 MECHANICAL HAZARD associated with surfaces, corners and edges9.4 Instability hazards9.5 Expelled parts HAZARD9.6.2.1 Audible acoustic energy9.8 Mechanical hazards associated with support systems11.6.5 Ingress of water and particulate matter into ME equipment and ME systems (only IPX7, needed for US probes)11.1 Excessive temperatures in ME EQUIPMENT11.6.6 Cleaning and disinfection of ME equipment and ME systems13.2 SINGLE FAULT CONDITIONS15.3 Mechanical strength16.6 Leakage currents 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT201.8.8.3 Dielectric strength201.8.9.3.4 Thermal cycling | 2017-02-14 | |
MED | IEC 60601-1:2005/AMD1:2012 | accepted clauses:4.11 Power input5.3 Ambient temperature, humidity, atmospheric pressure5.7 Humidity preconditioning treatment5.9 Determination of applied parts and accessible parts 7.1.2 Legibility of markings7.1.3 Durability of markings8.4.2 ACCESSIBLE PARTS and APPLIED PARTS8.5 Separation of parts8.7 Leakage currents and patient auxiliary currents 8.8 Insulation (without 8.8.4.1 and 8.8.4.2)8.9 Creepage distances and air clearances 8.10 Components and wiring9.2 Mechanical hazards associated with moving parts9.3 MECHANICAL HAZARD associated with surfaces, corners and edges9.4 Instability hazards9.5 Expelled parts HAZARD9.6.2.1 Audible acoustic energy9.8 Mechanical hazards associated with support systems11.6.5 Ingress of water and particulate matter into ME equipment and ME systems (only IPX7, needed for US probes)11.1 Excessive temperatures in ME EQUIPMENT11.6.6 Cleaning and disinfection of ME equipment and ME systems13.2 SINGLE FAULT CONDITIONS15.3 Mechanical strength16.6 Leakage currents 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT201.8.8.3 Dielectric strength201.8.9.3.4 Thermal cycling | 2012-03-21 | |
MED | IEC 60601-1:2005/AMD2:2020 | accepted clauses:4.11 Power input5.3 Ambient temperature, humidity, atmospheric pressure5.7 Humidity preconditioning treatment5.9 Determination of applied parts and accessible parts 7.1.2 Legibility of markings7.1.3 Durability of markings8.4.2 ACCESSIBLE PARTS and APPLIED PARTS8.5 Separation of parts8.7 Leakage currents and patient auxiliary currents 8.8 Insulation (without 8.8.4.1 and 8.8.4.2)8.9 Creepage distances and air clearances 8.10 Components and wiring9.2 Mechanical hazards associated with moving parts9.3 MECHANICAL HAZARD associated with surfaces, corners and edges9.4 Instability hazards9.5 Expelled parts HAZARD9.6.2.1 Audible acoustic energy9.8 Mechanical hazards associated with support systems11.6.5 Ingress of water and particulate matter into ME equipment and ME systems (only IPX7, needed for US probes)11.1 Excessive temperatures in ME EQUIPMENT11.6.6 Cleaning and disinfection of ME equipment and ME systems13.2 SINGLE FAULT CONDITIONS15.3 Mechanical strength16.6 Leakage currents 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT201.8.8.3 Dielectric strength201.8.9.3.4 Thermal cycling | 2021-02-04 | |
MED | IEC 60601-2-37:2007 | accepted clauses:201.7.9.3.101 Technical data regarding acoustic output levels201.11 Protection against excessive temperatures and other hazards201.12 Accuracy of controls and instruments and protection against hazardous outputs201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT201.8.8.3 Dielectric strength201.8.9.3.4 Thermal cycling | 2017-02-14 | |
MED | IEC 60601-2-37:2007/AMD1:2015 | accepted clauses:201.7.9.3.101 Technical data regarding acoustic output levels201.11 Protection against excessive temperatures and other hazards201.12 Accuracy of controls and instruments and protection against hazardous outputs201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT201.8.8.3 Dielectric strength201.8.9.3.4 Thermal cycling | 2012-03-21 |