CTF

GE Healthcare Austria GmbH & Co OG

 
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Standards in Scope

Category
Standard
Tests/Clauses
Acceptance Date
Responsible National Certification Body(s)
MEDIEC 60601-1:2005
accepted clauses: 4.11 Power input 5.3 Ambient temperature, humidity, atmospheric pressure 5.7 Humidity preconditioning treatment5.9 Determination of applied parts and accessible parts 8.5 Separation of parts 8.7 Leakage currents and patient auxiliary currents 8.8 Insulation (without 8.8.4.1 and 8.8.4.2) 8.10 Components and wiring 8.9 Creepage distances and air clearances 9.2 Mechanical hazards associated with moving parts 9.4 Instability hazards 9.8 Mechanical hazards associated with support systems 11.6.5 Ingress of water and particulate matter into ME equipment and ME systems (only IPX7, needed for US probes) 11.1 Excessive temperatures in ME EQUIPMENT 11.6.6 Cleaning and disinfection of ME equipment and ME systems 13.2 SINGLE FAULT CONDITIONS 15.3 Mechanical strength 16.6 Leakage currents 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT 201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT 201.8.8.3 Dielectric strength 201.8.9.3.4 Thermal cycling
2017-02-14
MEDIEC 60601-1:2005/AMD1:2012
accepted clauses: 4.11 Power input 5.3 Ambient temperature, humidity, atmospheric pressure 5.7 Humidity preconditioning treatment5.9 Determination of applied parts and accessible parts 8.5 Separation of parts 8.7 Leakage currents and patient auxiliary currents 8.8 Insulation (without 8.8.4.1 and 8.8.4.2) 8.10 Components and wiring 8.9 Creepage distances and air clearances 9.2 Mechanical hazards associated with moving parts 9.4 Instability hazards 9.8 Mechanical hazards associated with support systems 11.6.5 Ingress of water and particulate matter into ME equipment and ME systems (only IPX7, needed for US probes) 11.1 Excessive temperatures in ME EQUIPMENT 11.6.6 Cleaning and disinfection of ME equipment and ME systems 13.2 SINGLE FAULT CONDITIONS 15.3 Mechanical strength 16.6 Leakage currents 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT 201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT 201.8.8.3 Dielectric strength 201.8.9.3.4 Thermal cycling
2012-03-21
MEDIEC 60601-2-37:2007
accepted clauses: 201.7.9.3.101 Technical data regarding acoustic output levels 201.11201.11 Protection against excessive temperatures and other hazards 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT 201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT 201.8.8.3 Dielectric strength 201.8.9.3.4 Thermal cycling
2017-02-14
MEDIEC 60601-2-37:2007/AMD1:2015
accepted clauses: 201.7.9.3.101 Technical data regarding acoustic output levels 201.11201.11 Protection against excessive temperatures and other hazards 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT 201.8.7.4.8 Measurement of the PATIENT AUXILIARY CURRENT 201.8.8.3 Dielectric strength 201.8.9.3.4 Thermal cycling
2012-03-21