Philips Medical Systems North America Company
Philips Medical Systems North America Company
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2021-11-04 |
Further information
Stage | Country | Name |
|---|---|---|
3 | United States of America |
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 |
|---|---|---|---|---|
EMC | CISPR 11:2015 | 6.2.1.3 Measurement of conducted disturbances on the mains6.3.1.3 Measurement of conducted disturbances on the mains6.3.2.3 "Measurement of Radiated disturbances150 kHz-30MHz"6.3.2.4 "Measurement of Radiated disturbances1GHz-18GHz"7.3.3 Measurement of conducted disturbances on the mains when the AMN can not be used6.2.2.3, 6.3.2.3 "Measurement of Radiated disturbances30 MHz – 1 GHz" | 2021-11-04 | |
EMC | CISPR 11:2015/AMD1:2016 | 6.2.1.3 Measurement of conducted disturbances on the mains6.3.1.3 Measurement of conducted disturbances on the mains6.3.2.3 "Measurement of Radiated disturbances150 kHz-30MHz"6.3.2.4 "Measurement of Radiated disturbances1GHz-18GHz"7.3.3 Measurement of conducted disturbances on the mains when the AMN can not be used6.2.2.3, 6.3.2.3 "Measurement of Radiated disturbances30 MHz – 1 GHz" | 2021-11-04 | |
EMC | CISPR 11:2015/AMD2:2019 | 6.2.1.3 Measurement of conducted disturbances on the mains6.3.1.3 Measurement of conducted disturbances on the mains6.3.2.3 "Measurement of Radiated disturbances150 kHz-30MHz"6.3.2.4 "Measurement of Radiated disturbances1GHz-18GHz"7.3.3 Measurement of conducted disturbances on the mains when the AMN can not be used6.2.2.3, 6.3.2.3 "Measurement of Radiated disturbances30 MHz – 1 GHz" | 2021-11-04 | |
EMC | IEC 60601-1-2:2014 | 7.1.1 Emission of Industrial Scientific and medical equipment (CISPR 11 - ed.5.1 and CISPR 14-1 - ed.5.0) – conducted disturbances (CISPR 11: subclause 6.2.1.3 and 6.3.1.3; CISPR 14-1: 4.1.1)7.1.1 Emission of Industrial Scientific and medical equipment (CISPR 11 - ed.5.1) – radiated disturbances 150 kHz – 30 MHz (subclause 6.3.2.3)7.1.1 Emission of Industrial Scientific and medical equipment (CISPR 11 - ed.5.1 and CISPR 14-1 - ed.5.0)) – radiated disturbances 30 MHz – 1 GHz (CISPR 11: subclause 6.2.2.3 and 6.3.2.3; CISPR 14-1: subclause 4.1.3)7.1.1 Emission of Industrial Scientific and medical equipment (CISPR 11 - ed.5.1) – radiated disturbances 1 GHz to 18 GHz (subclause 6.3.2.4)7.1.7 ME Equipment whose main functions are performed by motors and switching or regulating devices (CISPR 14-1 - ed.5.0) – conducted disturbances on the output power lines (subclause 4.1.1)7.2.1 Harmonic distortion (IEC 61000-3-2:2005+A1:2008+A2:2009 – ed.3.2) – subclause 6.27.2.2 Voltage fluctuations and flicker (IEC 61000-3-3:2013 – ed.3.0) – clause 68 Immunity test to electrostatic discharges (IEC 61000-4-2:2008 – ed.2.0) 8 Immunity test to radiated electromagnetic field (IEC 61000-4-3:2006+A1:2007+A2:2010 – ed.3.2) 8 Immunity tests to electrical fast transients / bursts (IEC 61000-4-4:2012 – ed.3.0) 8 Immunity test to surges (IEC 61000-4-5:2005 – ed.3.0) 8 Immunity test to continuous conducted disturbances (IEC 61000-4-6:2013 – ed.4.0) 8 Immunity test to power frequency magnetic fields (IEC 61000-4-8:2009 – ed.2.0)8 Immunity test to voltage dips, short interruptions and voltage variations on power supply input lines (IEC 61000-4-11:2004 – ed.2.0) | 2021-11-04 | |
EMC | IEC 61000-3-2:2005 | 6.2 Measurement of harmonics | 2021-11-04 | |
EMC | IEC 61000-3-2:2005/AMD1:2008 | 6.2 Measurement of harmonics | 2021-11-04 | |
EMC | IEC 61000-3-3:2013 | 6 Measurement of flickers and voltage fluctuations | 2021-11-04 | |
EMC | IEC 61000-4-2:2008 | 8.3 "Immunity test to ElectrostaticDischarges" | 2021-11-04 | |
EMC | IEC 61000-4-3:2006 | 8 Immunity test to radiated electromagnetic field | 2021-11-04 | |
EMC | IEC 61000-4-3:2006/AMD1:2007 | 8 Immunity test to radiated electromagnetic field | 2021-11-04 | |
EMC | IEC 61000-4-3:2006/AMD2:2010 | 8 Immunity test to radiated electromagnetic field | 2021-11-04 | |
EMC | IEC 61000-4-4:2012 | 8 Immunity test to Fast transients | 2021-11-04 | |
EMC | IEC 61000-4-5:2014 | 7 Surge immunity test | 2021-11-04 | |
EMC | IEC 61000-4-5:2014/AMD1:2017 | 7 Surge immunity test | 2021-11-04 | |
EMC | IEC 61000-4-6:2013 | 8 Immunity test to continuous conducted disturbances | 2021-11-04 | |
EMC | IEC 61000-4-8:2009 | 8 Immunity test to Power-frequency Magnetic fields | 2021-11-04 | |
EMC | IEC 61000-4-11:2004 | 8 Immunity test to voltage dips, voltage variations and short interruptions | 2021-11-04 | |
EMC | IEC 61000-6-1:2016 | 1.1 "Immunity test to Power-frequencyMagnetic fields"1.2, 1.3 "Immunity test to Radiated Electromagneticfield"1.4 Immunity test to Electrostatic Discharges 2.1, 3.1, 4.1 "Immunity test to Continuousconducted disturbances""2.3, 3.3, 4.5" Immunity test to Fast transients"2.2, 3.2, 4.4" Immunity test to Surges4.2, 4.3 Immunity test to voltage dips, voltage variations and short interruptions | 2021-11-04 | |
EMC | IEC 61000-6-2:2016 | 1.1 "Immunity test to Power-frequencyMagnetic fields"1.2, 1.3 "Immunity test to Radiated Electromagneticfield"1.4 Immunity test to Electrostatic Discharges 2.1, 3.1, 4.1 "Immunity test to Continuousconducted disturbances""2.3, 3.3, 4.5" Immunity test to Fast transients"2.2, 3.2, 4.4" Immunity test to Surges4.2, 4.3 Immunity test to voltage dips, voltage variations and short interruptions | 2021-11-04 | |
EMC | IEC 61000-6-3:2006 | 2.1 Measurement of conducted disturbances on the mains4.1 Measurement of conducted common mode disturbance on telecommunications/network ports (CISPR 22)3.1 Measurement of conducted common mode disturbance on DC ports2.1 "Measurement of Discontinuousdisturbance(terminal voltage)"2.1 Measurement of harmonics according to IEC 61000-3-2 2.1 EMISSION-Limits for harmonics currents producted by equipment connected to public low-voltage systems whit input current > 16 A and inferior or equal 75A per phase (IEC 61000-3-12)2.1 "Measurement of flickers and voltage fluctuationsaccording to IEC 61000-3-3"1.1, 1.2 Measurement of Radiated disturbances up to 1 GHz 1.3 Measurement of Radiated disturbances according to IEC 61000-4-201.4 Measurement of Radiated disturbances above 1 GHz | 2022-10-05 | |
EMC | IEC 61000-6-3:2006/AMD1:2010 | 2.1 Measurement of conducted disturbances on the mains4.1 Measurement of conducted common mode disturbance on telecommunications/network ports (CISPR 22)3.1 Measurement of conducted common mode disturbance on DC ports2.1 "Measurement of Discontinuousdisturbance(terminal voltage)"2.1 Measurement of harmonics according to IEC 61000-3-2 2.1 EMISSION-Limits for harmonics currents producted by equipment connected to public low-voltage systems whit input current > 16 A and inferior or equal 75A per phase (IEC 61000-3-12)2.1 "Measurement of flickers and voltage fluctuationsaccording to IEC 61000-3-3"1.1, 1.2 Measurement of Radiated disturbances up to 1 GHz 1.3 Measurement of Radiated disturbances according to IEC 61000-4-201.4 Measurement of Radiated disturbances above 1 GHz | 2022-10-05 | |
EMC | IEC 61000-6-4:2006 | 2.1 Measurement of conducted disturbances on the mains4.1 Measurement of conducted common mode disturbance on telecommunications/network ports (CISPR 22)2.1 Measurement of Discontinuous disturbance (terminal voltage) 1.1, 1.2 Measurement of Radiated disturbances up to 1 GHz1.3 "Measurement of Radiated disturbances according to IEC 61000-4-20"1.4 Measurement of Radiated disturbances above 1 GHz | 2021-11-04 | |
EMC | IEC 61000-6-4:2006/AMD1:2010 | 2.1 Measurement of conducted disturbances on the mains4.1 Measurement of conducted common mode disturbance on telecommunications/network ports (CISPR 22)2.1 Measurement of Discontinuous disturbance (terminal voltage) 1.1, 1.2 Measurement of Radiated disturbances up to 1 GHz1.3 "Measurement of Radiated disturbances according to IEC 61000-4-20"1.4 Measurement of Radiated disturbances above 1 GHz | 2021-11-04 | |
EMC | IEC 61326-1:2012 | 6 Immunity test to electrostatic discharges (IEC 61000-4-2)6 Immunity test to Radiated Electromagnetic field (IEC 61000-4-3)6 Immunity test to power frequency magnetic fields (IEC 61000-4-8)6 Immunity test to voltage dips, voltage variations and short interruptions (IEC 61000-4-11) 6 Immunity test to Fast transients (IEC 61000-4-4) 6 "Immunity test to Surges (IEC 61000-4-5)"6 Immunity test to continuous conducted disturbances (IEC 61000-4-6)7.2 EMISSION-Measurement of conducted disturbances on the mains, Measurement of Radiated disturbances (CISPR 11 – see also EQL) 7.2 EMISSION-Measurement of harmonics (IEC 61000-3-2)7.2 EMISSION-Measurement of flickers (IEC 61000-3-3)201.8.5.5.1 Defibrillation protection – Common mode test | 2021-11-04 | |
ITAV | IEC 62368-1:2018 | 5.2.2.2 Steady-state voltage and current limits5.2.2.4 Single pulse limits 5.3.2 Accessibility to electrical energy sources and safeguards5.4.1.4, 9.3, Annex E Maximum operating temperatures for materials, components and systems5.4.1.5.3 Thermal cycling test procedure5.4.1.10.3 Ball pressure test5.4.2, 5.4.3, 5.4.4, Annex X Clearances, creepage distance, solid insulation5.4.2 Clearances5.4.2.3.2.5 Determining transient voltage levels by measurement5.4.2.4 Determining the adequacy of a clearance using an electric strength test5.4.3 Creepage distances5.4.6 Insulation of internal wire as a part of a supplementary safeguard5.4.7 Tests for semiconductor components and for cemented joints5.4.8 Humidity Conditioning5.4.9.1 Test procedure for type testing of solid insulation5.4.10 Safeguards against transient voltages from external circuits5.4.11 Separation between external circuits and earth5.5.2.2 Capacitor discharge5.6.3 Requirements for protective earthing conductors5.6.4.1 "Requirements for protective bonding conductors - Resistance of protective conductors and their terminations"5.6.6 Resistance of the protective bonding system5.7 Prospective touch voltage touch current and protective conductor current6.2.2 Power source circuit classification6.3 Safeguards against fire under normal operating conditions and abnormal operating conditions6.4.3 Reduction of the likelihood of ignition under single fault conditions in PS2 circuits and PS3 circuits6.4.7 Separation of combustible materials from a PIS6.4.8.3.3, Annex S.2 Top openings and top openings properties6.6 Safeguards against fire due to the connection of additional equipment8.2 Mechanical energy source classifications8.6.2 Static stability for floor standing equipment8.6.3 Relocation stability8.6.4 Glass slide test8.6.5 Horizontal force test8.7 Equipment mounted to a wall or ceiling - Test 18.7 Equipment mounted to a wall or ceiling - Test 28.7 Equipment mounted to a wall or ceiling - Test 38.8 Handle strength test method8.9 Wheels or casters attachment requirement8.10.4 Carts, stands and similar carriers - Impact Test8.10.5 Carts, stands and similar carriers - Mechanical Stability Test9.3.2 Touch temperature limits - Test method and compliance criteriaAnnex B.2.5 Input testAnnex B.3 Simulated abnormal operating conditionsAnnex B.4 Simulated single fault conditions - GeneralAnnex B.4.2 Temperature controlling deviceAnnex B.4.4 Functional insulationAnnex B.4.5 Short-circuit and interruption of electrodes in tubes and semiconductorsAnnex B.4.6 Short-circuit or disconnection of passive componentsAnnex B.4.7 Continuous operation of componentsAnnex F.3.10 Marking Legibility & DurabilityAnnex G.3.5 Safeguard components not mentioned in G.3.1 to G.3.4Annex G.7.1 Mains supply cords - Flex TestingAnnex G.7.3.2 Mains supply cords - Cord strain reliefAnnex G.7.5 Mains supply cords - Non-detachable cord bend protectionAnnex G.7.6.2 Mains supply cords - Stranded wireAnnex P.2 Safeguards against entry of solid foreign objectsAnnex Q Circuits intended for interconnection with building wiringAnnex T.2 - T.4 Steady force testAnnex T.5 Steady force test, 250 NAnnex T.6 Enclosure impact testAnnex T.7 Drop testAnnex T.8 Stress relief testAnnex T.9 Impact Test | 2021-11-04 | |
ITAV | IEC 62368-1:2014 | 5.2.2.2 Steady-state voltage and current limits5.2.2.4 Single pulse limits 5.3.2 Accessibility to electrical energy sources and safeguards5.4.1.4, 9.3, Annex E Maximum operating temperatures for materials, components and systems5.4.1.5.3 Thermal cycling test procedure5.4.1.10.3 Ball pressure test5.4.2, 5.4.3, 5.4.4, Annex X Clearances, creepage distance, solid insulation5.4.2 Clearances5.4.2.3.2.5 MEASUREMENT OF TRANSIENT VOLTAGE LEVELS5.4.2.4 Determining the adequacy of a clearance using an electric strength test5.4.3 Creepage distances5.4.6 Insulation of internal wire as a part of a supplementary safeguard5.4.7 Tests for semiconductor components and for cemented joints5.4.8 Humidity Conditioning5.4.9.1 Test procedure for type testing of solid insulation5.4.10 Safeguards against transient voltages from external circuits5.4.11 Separation between external circuits and earth5.5.2.2 Safeguards against capacitor discharge after disconnection of a connector5.6.3 Requirements for protective earthing conductors5.6.4.1 "Requirements for protective bonding conductors - Resistance of protective conductors and their terminations"5.6.6 Resistance of the protective bonding system5.7 Prospective touch voltage touch current and protective conductor current6.2.2 Power source circuit classification6.3 Safeguards against fire under normal operating conditions and abnormal operating conditions6.4.3 Reduction of the likelihood of ignition under single fault conditions in PS2 circuits and PS3 circuits6.4.7 Separation of combustible materials from a PIS6.4.8.3.3, Annex S.2 Top openings and top openings properties6.6 Safeguards against fire due to the connection of additional equipment8.2 Mechanical energy source classifications8.6.2 Static stability for floor standing equipment8.6.3 Relocation stability8.6.4 Glass slide test8.6.5 Horizontal force test8.7 Equipment mounted to a wall or ceiling - Test 18.7 Equipment mounted to a wall or ceiling - Test 28.7 Equipment mounted to a wall or ceiling - Test 38.8 Handle strength test method8.9 Wheels or casters attachment requirement8.10.4 Carts, stands and similar carriers - Impact Test8.10.5 Carts, stands and similar carriers - Mechanical Stability Test9.2.5 Touch temperature limits - Test method and compliance criteriaAnnex B.2.5 Input testAnnex B.3 Simulated abnormal operating conditionsAnnex B.4 Simulated single fault conditions - GeneralAnnex B.4.2 Temperature controlling deviceAnnex B.4.4 Functional insulationAnnex B.4.5 Short-circuit and interruption of electrodes in tubes and semiconductorsAnnex B.4.6 Short-circuit or disconnection of passive componentsAnnex B.4.7 Continuous operation of componentsAnnex F.3.10 Test for the permanence of markingsAnnex G.3.5 Safeguard components not mentioned in G.3.1 to G.3.4Annex G.7.1 Mains supply cords - Flex TestingAnnex G.7.3.2 Mains supply cords - Cord strain reliefAnnex G.7.5 Mains supply cords - Non-detachable cord bend protectionAnnex G.7.6.2 Mains supply cords - Stranded wireAnnex P.2 Safeguards against entry of solid foreign objectsAnnex Q Circuits intended for interconnection with building wiringAnnex T.2 - T.4 Steady force testAnnex T.5 Steady force test, 250 NAnnex T.6 Enclosure impact testAnnex T.7 Drop testAnnex T.8 Stress relief testAnnex T.9 Impact Test | 2021-11-04 | |
MED | IEC 60601-1:2005 | 15.3.4 Drop Impact15.5.1.2 Transformer Short Circuit15.5.1.3 Transformer Overload16.6.1 ME System Leakage Current5.7 Humidity Conditioning5.9.2 Determination of Accessible Parts7.1.2 Legibility of Markings7.1.3 Durability of Markings7.2.6 Voltage Mismatch8.1 b Shorting One MOP8.2.2 Incorrect Polarity8.4.2 Limitation of Voltage, Current or Power8.4.3 Voltage or Charge Limitation8.4.4 Voltage Limitation (Part 2)8.5.2.3 Patient Lead Connection8.5.4 Working Voltage Measurements8.5.5 Defib-Proof Applied Parts8.5.5.2 Defib-Proof Applied Parts, Energy Reduction8.6.4 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 b) Patient Leakage Current, Mains on F-Type AP8.7.4.7 c) Patient Leakage Current, Mains on I/O8.7.4.7 d) Patient Leakage Current, Mains on Non-PE Enclosure8.7.4.7 h) Total Patient Leakage Current8.7.4.8 Patient Auxiliary Current8.7.3 e) Non-Frequency-Weighted Leakage Current8.8.3 Dielectric Voltage Withstand8.9.2 Short Circuiting in Lieu of Spacings8.9.3 Thermal Cycling for Spaces Filled with Insulating Compound8.11.3.5 Cord Anchorage8.11.3.6 Cord Bending8.11.4.2 Arrangement of Mains Terminal8.11.4.3 Fixing of Mains Terminal9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.4.2 Stability and Transportability9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.4.4 c Handle Loading9.8.2 Tesile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.3.3 Mechanical Strength - Dynamic Forces9.8.4 Suspension System w/ Safety Devices Loading (60601-1 AM1 Only)11 Temperature11.1.3 Change of Resistance Calculations11.6.2 Overflow11.6.3 Spillage11.6.4 Leakage11.6.6 Cleaning and Disinfection11.6.7 Sterilization11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.1.2 Power Availability13.2 Failure of Thermostats13.2 Impairment of Cooling13.2 Locking of Moving Parts13.2 Interruption and Shorting of Motor Cap13.2.13.2 Overload, Heating Elements13.2.13.3 b Overload, Motor15.3.2 Enclosure Force15.3.3 Enclosure Impact15.3.5 Rough Handling15.3.6 Mold Stress Relief15.4.2.1 Temperature and Overload Control Devices15.4.3 Reversed Battery Connection / Overcharging15.4.6 Actuating Parts of Controls15.4.7.1 Cord-Connected Foot Operated Control Devices15.5.2 Transformer Dielectric Voltage Withstand11.6.5 Harmful Ingress (Water and Particulates)8.8.4.1 Ball Pressure9.4.2.4.2 Mobile Equipment Force for Propulsion4.11 Power Input | 2021-11-04 | |
MED | IEC 60601-1:2005/AMD1:2012 | 15.3.4 Drop Impact15.5.1.2 Transformer Short Circuit15.5.1.3 Transformer Overload16.6.1 ME System Leakage Current5.7 Humidity Conditioning5.9.2 Determination of Accessible Parts7.1.2 Legibility of Markings7.1.3 Durability of Markings7.2.6 Voltage Mismatch8.1 b Shorting One MOP8.2.2 Incorrect Polarity8.4.2 Limitation of Voltage, Current or Power8.4.3 Voltage or Charge Limitation8.4.4 Voltage Limitation (Part 2)8.5.2.3 Patient Lead Connection8.5.4 Working Voltage Measurements8.5.5 Defib-Proof Applied Parts8.5.5.2 Defib-Proof Applied Parts, Energy Reduction8.6.4 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 b) Patient Leakage Current, Mains on F-Type AP8.7.4.7 c) Patient Leakage Current, Mains on I/O8.7.4.7 d) Patient Leakage Current, Mains on Non-PE Enclosure8.7.4.7 h) Total Patient Leakage Current8.7.4.8 Patient Auxiliary Current8.7.3 e) Non-Frequency-Weighted Leakage Current8.8.3 Dielectric Voltage Withstand8.9.2 Short Circuiting in Lieu of Spacings8.9.3 Thermal Cycling for Spaces Filled with Insulating Compound8.11.3.5 Cord Anchorage8.11.3.6 Cord Bending8.11.4.2 Arrangement of Mains Terminal8.11.4.3 Fixing of Mains Terminal9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.4.2 Stability and Transportability9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.4.4 c Handle Loading9.8.2 Tesile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.3.3 Mechanical Strength - Dynamic Forces9.8.4 Suspension System w/ Safety Devices Loading (60601-1 AM1 Only)11 Temperature11.1.3 Change of Resistance Calculations11.6.2 Overflow11.6.3 Spillage11.6.4 Leakage11.6.6 Cleaning and Disinfection11.6.7 Sterilization11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.1.2 Power Availability13.2 Failure of Thermostats13.2 Impairment of Cooling13.2 Locking of Moving Parts13.2 Interruption and Shorting of Motor Cap13.2.13.2 Overload, Heating Elements13.2.13.3 b Overload, Motor15.3.2 Enclosure Force15.3.3 Enclosure Impact15.3.5 Rough Handling15.3.6 Mold Stress Relief15.4.2.1 Temperature and Overload Control Devices15.4.3 Reversed Battery Connection / Overcharging15.4.6 Actuating Parts of Controls15.4.7.1 Cord-Connected Foot Operated Control Devices15.5.2 Transformer Dielectric Voltage Withstand11.6.5 Harmful Ingress (Water and Particulates)8.8.4.1 Ball Pressure9.4.2.4.2 Mobile Equipment Force for Propulsion4.11 Power Input | 2021-11-04 | |
MED | IEC 60601-1:2005/AMD2:2020 | 15.3.4 Drop Impact15.5.1.2 Transformer Short Circuit15.5.1.3 Transformer Overload16.6.1 ME System Leakage Current5.7 Humidity Conditioning5.9.2 Determination of Accessible Parts7.1.2 Legibility of Markings7.1.3 Durability of Markings7.2.6 Voltage Mismatch8.1 b Shorting One MOP8.2.2 Incorrect Polarity8.4.2 Limitation of Voltage, Current or Power8.4.3 Voltage or Charge Limitation8.4.4 Voltage Limitation (Part 2)8.5.2.3 Patient Lead Connection8.5.4 Working Voltage Measurements8.5.5 Defib-Proof Applied Parts8.5.5.2 Defib-Proof Applied Parts, Energy Reduction8.6.4 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 b) Patient Leakage Current, Mains on F-Type AP8.7.4.7 c) Patient Leakage Current, Mains on I/O8.7.4.7 d) Patient Leakage Current, Mains on Non-PE Enclosure8.7.4.7 h) Total Patient Leakage Current8.7.4.8 Patient Auxiliary Current8.7.3 e) Non-Frequency-Weighted Leakage Current8.8.3 Dielectric Voltage Withstand8.9.2 Short Circuiting in Lieu of Spacings8.9.3 Thermal Cycling for Spaces Filled with Insulating Compound8.11.3.5 Cord Anchorage8.11.3.6 Cord Bending8.11.4.2 Arrangement of Mains Terminal8.11.4.3 Fixing of Mains Terminal9.2.2.2 Measurement of Gaps (Trapping Zones)9.2.3.2 Overtravel End Stops (60601-1 AM 1 Only)9.4.2 Stability and Transportability9.4.3.1 Instability from Unwanted Lateral Movement (Including Sliding)9.4.3.2 Instability Excluding Transport9.4.4 c Handle Loading9.8.2 Tesile Safety Factor9.8.3.1 Mechanical Strength - Patient Support System9.8.3.2 Mechanical Strength - Foot Rests/Sitting9.8.3.3 Mechanical Strength - Dynamic Forces9.8.4 Suspension System w/ Safety Devices Loading (60601-1 AM1 Only)11 Temperature11.1.3 Change of Resistance Calculations11.6.2 Overflow11.6.3 Spillage11.6.4 Leakage11.6.6 Cleaning and Disinfection11.6.7 Sterilization11.8 Interruption of the Power Supply13 Abnormal Operation Testing13.1.2 Power Availability13.2 Failure of Thermostats13.2 Impairment of Cooling13.2 Locking of Moving Parts13.2 Interruption and Shorting of Motor Cap13.2.13.2 Overload, Heating Elements13.2.13.3 b Overload, Motor15.3.2 Enclosure Force15.3.3 Enclosure Impact15.3.5 Rough Handling15.3.6 Mold Stress Relief15.4.2.1 Temperature and Overload Control Devices15.4.3 Reversed Battery Connection / Overcharging15.4.6 Actuating Parts of Controls15.4.7.1 Cord-Connected Foot Operated Control Devices15.5.2 Transformer Dielectric Voltage Withstand11.6.5 Harmful Ingress (Water and Particulates)8.8.4.1 Ball Pressure9.4.2.4.2 Mobile Equipment Force for Propulsion4.11 Power Input4.2.3.2ENVIRONMENTAL SHOCK TO TRANSIT-OPERABLE ME EQUIPMENT4.2.3.1ENVIRONMENTAL OPERATING CONDITIONS10.1.2 a)SHOCK TEST (IEC 60068-2-27:200810.1.3 a) 1SHOCK TEST (IEC 60068-2-27:2008) for other than HAND-HELD EQUIPMENT, parts, and mounting ACCESSORIES under the following conditions (Test Type 1)10.1.3 a) 2SHOCK TEST (IEC 60068-2-27:2008) on other than HAND-HELD ME EQUIPMENT, parts, and mounting ACCESSORIES under the following conditions (Test Type 2)10.1.3 b) 1Shock test (IEC 60068-2-27:2008) on hand-held me equipment parts, and mounting accessories using the following conditions (Test Type 1)10.1.3 b) 2Shock test (IEC 60068-2-27:2008) on hand-held me equipment parts, and mounting accessories using the following conditions (Test Type 2)10.1.3 d)Free fall test (IEC 60068-2-31:2008), using PROCEDURE 1, on PORTABLE and MOBILE ME EQUIPMENT, parts, and mounting ACCESSORIES10.1.3 c)BROAD-BAND RANDOM VIBRATION TEST (IEC 60068-2-64:2008)4.2.3ENVIRONMENTAL CONDITIONS OF TRANSPORT AND STORAGE BETWEEN USES4.2.2.1Continuous operating conditions4.2.2.2Transient operating conditions10.1.2a1Shock test (IEC 60068-2-27:2008) for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT and mounting ACCESSORIES intended for use in a road ambulance under the following conditions* (Test Type 1)10.1.2bBroad-band ra | 2023-07-17 | |
MED | IEC 60601-1-8:2006 | 6.3.3.1 Characteristics of auditory ALARM SIGNALS6.3.3.2 Measurements of volume of auditory alarm signals and information signals6.3.2.2 Characteristics of visual ALARM SIGNALS | 2021-11-04 | |
MED | IEC 60601-1-8:2006/AMD1:2012 | 6.3.3.1 Characteristics of auditory ALARM SIGNALS6.3.3.2 Measurements of volume of auditory alarm signals and information signals6.3.2.2 Characteristics of visual ALARM SIGNALS | 2021-11-04 | |
MED | IEC 60601-1-11:2015 | 4.2.3.2 ENVIRONMENTAL SHOCK TO TRANSIT-OPERABLE ME EQUIPMENT4.2.3.1 ENVIRONMENTAL OPERATING CONDITIONS10.1.2 a) SHOCK TEST (IEC 60068-2-27:200810.1.2 b) BROAD-BAND RANDOM VIBRATION TEST (IEC 60068-2-64:2008)10.1.3 a) 1 SHOCK TEST (IEC 60068-2-27:2008) for other than HAND-HELD EQUIPMENT, parts, and mounting ACCESSORIES under the following conditions (Test Type 1)10.1.3 a) 2 SHOCK TEST (IEC 60068-2-27:2008) on other than HAND-HELD ME EQUIPMENT, parts, and mounting ACCESSORIES under the following conditions (Test Type 2)10.1.3 b) 1 Shock test (IEC 60068-2-27:2008) on hand-held me equipment parts, and mounting accessories using the following conditions (Test Type 1)10.1.3 b) 2 Shock test (IEC 60068-2-27:2008) on hand-held me equipment parts, and mounting accessories using the following conditions (Test Type 2)10.1.3 d) Free fall test (IEC 60068-2-31:2008), using PROCEDURE 1, on PORTABLE and MOBILE ME EQUIPMENT, parts, and mounting ACCESSORIES10.1.3 c) BROAD-BAND RANDOM VIBRATION TEST (IEC 60068-2-64:2008)4.2.3 ENVIRONMENTAL CONDITIONS OF TRANSPORT AND STORAGE BETWEEN USES | 2021-11-04 | |
MED | IEC 60601-1-12:2014 | 4.2.2.1 Continuous operating conditions4.2.2.2 Transient operating conditions10.1.2a1 Shock test (IEC 60068-2-27:2008) for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT and mounting ACCESSORIES intended for use in a road ambulance under the following conditions* (Test Type 1)10.1.2b Broad-band random vibration test (IEC 60068-2-64:2008) for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT and mounting ACCESSORIES intended for use in a road ambulance under the following conditions10.1.3 a) 1 "Shock test (IEC 60068-2-27:2008) for TRANSPORTABLE ME EQUIPMENT and its parts, including mounting ACCESSORIES under the following conditions*(Test Type 1)"10.1.3 a) 2 "Shock test (IEC 60068-2-27:2008) for TRANSPORTABLE ME EQUIPMENT and its parts, including mounting ACCESSORIES under the following conditions(Test Type 2)"10.1.3 b) Broad-band random vibration test (IEC 60068-2-64:2008) for TRANSPORTABLE ME EQUIPMENT and its parts, including mounting ACCESSORIES under the following conditions*10.1.3c Free fall test (IEC 60068-2-31:2008), using PROCEDURE 1, for TRANSPORTABLE ME EQUIPMENT and its parts, including mounting ACCESSORIES (for PORTABLE ME EQUIPMENT with carrying case if intended), under the following conditions*10.1.3 d) Free fall test (IEC 60068-2-31:2008), using PROCEDURE 1, on PORTABLE and MOBILE ME EQUIPMENT, parts, and mounting ACCESSORIES10.1.4a1 Shock test (IEC 60068-2-27:2008) for ME EQUIPMENT intended for airborne use and its parts, including mounting ACCESSORIES under the following conditions* (Test Type 1)10.1.4a2 Shock test (IEC 60068-2-27:2008) for ME EQUIPMENT intended for airborne use and its parts, including mounting ACCESSORIES under the following conditions (Test Type 2)10.1.2a2 Shock test (IEC 60068-2-27:2008) for FIXED or PERMANENTLY INSTALLED ME EQUIPMENT and mounting ACCESSORIES intended for use in a road ambulance under the following conditions (Test Type 2)4.2.1 Environmental conditions of transport and storage between uses | 2021-11-04 | |
MED | IEC 60601-2-4:2010 | 201.12.4.101 Output voltage: 201.109.3.1 Pace pulse duration accuracy201.8.5.5.101 Isolation of DEFIBRILLATOR ELECTRODES201.8.8.3(1) Dielectric Strength Test on Defibrillator High Voltage Circuits and the Corresponding Insulation Resistance Test 1 201.8.8.3(2) Dielectric Strength Test on Defibrillator High Voltage Circuit and the Corresponding Insulation Resistance Test 1 201.8.9.1.101b DEFIBRILLATOR ELECTRODES, high-voltage circuits and cables: 201.8.9.1.101b)201.8.9.1.101d DEFIBRILLATOR ELECTRODES, high-voltage circuits and cables: 201.8.9.1.101d)201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS: 201.11.6.3)201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS: 201.11.6.5)201.12.1 Accuracy of controls and instruments201.12.4.102/201.12.4.103 Unintentional Energy/Internal Discharge201.15.4.3.101 Non-rechargeable battery replacement201.15.4.3.103 Rechargeable battery201.15.4.101 DEFIBRILLATOR ELECTRODES and their cables201.101.1 Requirements for FREQUENT USE, MANUAL DEFIBRILLATORS201.101.2 Requirements for INFREQUENT USE, MANUAL DEFIBRILLATORS201.101.3 Requirements for FREQUENT USE, AUTOMATED EXTERNAL DEFIBRILLATORS201.101.4 Requirements for INFREQUENT USE, AUTOMATED EXTERNAL DEFIBRILLATORS201.102.2 Requirements for MANUAL DEFIBRILLATORS201.102.3.1 FREQUENT USE AED201.102.3.2 INFREQUENT USE AED201.103 Endurance201.105.1 ECG signal derived via DEFIBRILLATOR ELECTRODES201.105.2 ECG signal derived via any SEPARATE MONITORING ELECTRODES201.105.3 ECG signal derived via non-reusable DEFIBRILLATOR ELECTRODES201.106 Disturbance to the MONITOR from charging or internal discharging201.107 Requirements for RHYTHM RECOGNITION DETECTOR201.108.1.1 AC small signal impedance201.108.1.2 AC large signal impedance201.108.1.4 Defibrillation recovery201.108.1.6 DC offset voltage201.108.1.7 Electrode active area201.108.1.9 Packaging and shelf life201.108.1.10 Universal-function electrodes201.108.1.11 Cable length201.109.2.1 Separate pacing pathway201.109.3.2a Pace pulse duration stability201.109.3.2b Pace pulse duration stability 201.109.4.1 Pacing pulse current accuracy201.109.4.2 Pacing pulse current stability201.109.5.1 Pacing rate accuracy201.109.5.2a Pacing rate stability201.109.5.2b Pacing rate stability201.109.7 Demand pacing201.109.8 Pacer lead-off indication201.7.2.101 Concise operating instructions | 2021-11-04 | |
MED | IEC 60601-2-4:2010/AMD1:2018 | 201.12.4.101 Output voltage: 201.109.3.1 Pace pulse duration accuracy201.8.5.5.101 Isolation of DEFIBRILLATOR ELECTRODES201.8.8.3(1) Dielectric Strength Test on Defibrillator High Voltage Circuits and the Corresponding Insulation Resistance Test 1 201.8.8.3(2) Dielectric Strength Test on Defibrillator High Voltage Circuit and the Corresponding Insulation Resistance Test 1 201.8.9.1.101b DEFIBRILLATOR ELECTRODES, high-voltage circuits and cables: 201.8.9.1.101b)201.8.9.1.101d DEFIBRILLATOR ELECTRODES, high-voltage circuits and cables: 201.8.9.1.101d)201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS: 201.11.6.3)201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS: 201.11.6.5)201.12.1 Accuracy of controls and instruments201.12.4.102/201.12.4.103 Unintentional Energy/Internal Discharge201.15.4.3.101 Non-rechargeable battery replacement201.15.4.3.103 Rechargeable battery201.15.4.101 DEFIBRILLATOR ELECTRODES and their cables201.101.1 Requirements for FREQUENT USE, MANUAL DEFIBRILLATORS201.101.2 Requirements for INFREQUENT USE, MANUAL DEFIBRILLATORS201.101.3 Requirements for FREQUENT USE, AUTOMATED EXTERNAL DEFIBRILLATORS201.101.4 Requirements for INFREQUENT USE, AUTOMATED EXTERNAL DEFIBRILLATORS201.102.2 Requirements for MANUAL DEFIBRILLATORS201.102.3.1 FREQUENT USE AED201.102.3.2 INFREQUENT USE AED201.103 Endurance201.105.1 ECG signal derived via DEFIBRILLATOR ELECTRODES201.105.2 ECG signal derived via any SEPARATE MONITORING ELECTRODES201.105.3 ECG signal derived via non-reusable DEFIBRILLATOR ELECTRODES201.106 Disturbance to the MONITOR from charging or internal discharging201.107 Requirements for RHYTHM RECOGNITION DETECTOR201.108.1.1 AC small signal impedance201.108.1.2 AC large signal impedance201.108.1.4 Defibrillation recovery201.108.1.6 DC offset voltage201.108.1.7 Electrode active area201.108.1.9 Packaging and shelf life201.108.1.10 Universal-function electrodes201.108.1.11 Cable length201.109.2.1 Separate pacing pathway201.109.3.2a Pace pulse duration stability201.109.3.2b Pace pulse duration stability 201.109.4.1 Pacing pulse current accuracy201.109.4.2 Pacing pulse current stability201.109.5.1 Pacing rate accuracy201.109.5.2a Pacing rate stability201.109.5.2b Pacing rate stability201.109.7 Demand pacing201.109.8 Pacer lead-off indication201.7.2.101 Concise operating instructions | 2021-11-04 | |
MED | IEC 60601-2-23:2011 | 201.17, 202 "ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT and ME SYSTEMSElectromagnetic compatibility – Requirements and tests" | 2021-11-04 | |
MED | IEC 60601-2-24:2012 | 201.17, 202 "ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT and ME SYSTEMSElectromagnetic compatibility – Requirements and tests" | 2021-11-04 | |
MED | IEC 60601-2-25:2011 | 201.12.4.102.4 Lead Networks RECOVER TIME201.12.1.101.2 Essential Performance Amplitude Measurements201.12.1.101.3.1 Essential Performance Interval Measurements for absolute interval and wave duration201.12.1.101.3.2 Essential Performance Interval Measurements for biological ECGS201.12.4.101 Indication of inoperable Electrocardiograph201.12.4.102.3.2 Lead Networks Goldberger and Wilson Leads201.12.4.103 Input impedance; Test Signal Resulting From The Use of Manual or Automatic Protective Devices201.12.4.105.1 Common Mode Rejection201.12.4.105.2 Overload Tolerance201.12.4.105.3 FILTERS201.12.4.106.1 noise level201.12.4.106.2 Channel Crosstalk201.12.4.107.1.1.1 Frequency Response High Frequency Response201.12.4.107.1.1.2 Frequency Response low Frequency impulse Response201.12.4.107.1.2 Test with Calibration ECGs201.12.4.107.2 Linearity and Dynamic Range201.12.4.108.3.2 ECG Reporting on Paper Recording Speed201.12.4.109 Use with Cardiac Pacemakers202.6.2.101 Electrosurgery interference201.8.5.5.1 Protection Against The Effects Of Defibrillation; Test Signal Resulting From The Use of Manual or Automatic Protective Devices | 2021-11-04 | |
MED | IEC 60601-2-26:2012 | 201.8.5.5.1 Defibrillation protection – Common mode test201.12.1.101.1 Accuracy of signal reproduction201.8.5.5.1 Defibrillation protection – Differential mode test201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT201.12.1.101.2 Input dynamic range and differential offset voltage201.12.1.101.3 Input noise201.12.1.101.4 Frequency response201.12.1.101.5 Common mode rejection | 2021-11-04 | |
MED | IEC 60601-2-27:2011 | 202.6.2.101 Electrosurgery interference201.8.5.5.1 b) Defibrillation-Protection - Differential mode test201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT (A)201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT (B)201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT (C)201.11.8.101 Protection against depletion of battery201.12.1.101.1a Accuracy of signal reproduction – Measurement of output signal201.12.1.101.1b Accuracy of signal reproduction – Verification of visibility of the output signal & measurement of output peak-to-valley amplitude 201.12.1.101.2 Input dynamic range and differential offset voltage – Measurement of time-varying output signal amplitude and calculation of % change over the d.c. offset voltage range of ±300 mV201.12.1.101.3 Input impedance – Measurement of output signal amplitude at 0.67 Hz and 40 Hz and dc offset voltage range of ±300 mV 201.12.1.101.4 Input Noise 201.12.1.101.5 Multi-channel crosstalk – Measurement of unwanted output signal in the unused lead wires201.12.1.101.6 Gain control and stability – Monitoring displayed signal amplitude201.12.1.101.7 Sweep Speed – Measurement of the distance between successive peaks for a time base of 25 mm/s201.12.1.101.8 a) Frequency response – Measurement of Sine wave using Method A of Subclause 201.12.1.101.8 a)201.12.1.101.8 a) Frequency response – Measurement of peak amplitude using Method B of Subclause 201.12.1.101.8 a)201.12.1.101.9 Gain Indicator – Measurement of amplitude of the step change in display output obtained by applying a 1 mV ± 0.01 mV signal to the appropriate lead & amplitude of the step change in display output obtained at calibration voltage 201.12.1.101.10 Common mode rejection– Measurement of peak-to-valley output signal amplitude over a period not less than 15 Sec when a signal specified on the table was connected between earth and all LEAD WIRES connected together.201.12.1.101.11 Baseline reset201.12.1.101.12 Pacemaker pulse display capability201.12.1.101.13 Rejection of pacemaker pulses (A)201.12.1.101.13 B Rejection of pacemaker pulses – Monitoring the indicated heart rates relative to the heart rates specified by the manufacturer – Same conditions as in Table 201.12.1.101.13 a), except modified per condition g): A pulse with amplitude and duration identical to the ventricular pacing pulse applied, except preceding the latter by 150 ms 201.12.1.101.13 C Rejection of pacemaker pulses – Monitoring the indicated heart rates relative to the heart rates specified by the manufacturer – Same conditions as in Table 201.12.1.101.13 a), except modified per condition h): A pulse with amplitude and duration identical to the ventricular pacing pulse applied, except preceding the latter by 250 ms 201.12.1.101.14 Synchronizing pulse for cardioversion201.12.1.101.15 Accuracy of Detected Heart Rate201.12.1.101.15 b) Accuracy of Detected Heart Rate – Adult mode with a QRS amplitude of 0.15mV and afterwards with QRS duration of 10ms and amplitude of 1.0 mV201.12.1.101.16 Output display– Channel High and Aspect Ratio 201.12.1.101.17 Tall T-wave rejection capability208.6.6.2.103 Time to alarm for heart rate ALARM CONDITIONS208.6.6.2.104 TECHNICAL ALARM CONDITION indicating inoperable ME EQUIPMENT201.8.5.5.2 Energy reduction test - Measurement of the defibrillator energy delivered to the patient 201.15.4.4.101 Indicator of battery operation and battery status201.8.5.5.1 a) Defibrillation-Protection - Common mode test | 2021-11-04 | |
MED | IEC 60601-2-34:2011 | 208.6.6.2.103 Detection of disconnected catheter201.8.5.5.1b Defibrillation protection, peak voltage201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS201.11.8 Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT201.11.8.101 Protection against depletion of battery201.12.1.101.1 Measurement range, sensitivity, repeatability, non-linearity, drift and hysteresis201.12.1.101.2 Accuracy of systolic and diastolic pressure201.12.1.101.3 Frequency response201.15.3.4.101 TRANSDUCER drop test208.6.6.2.101 ALARM LIMITS and delay time of physiological ALARM SIGNALS208.6.6.2.102 Detection of TRANSDUCER and TRANSDUCER cable fault201.9.7.5 Pressure vessels201.8.5.5.1a Defibrillation protection, recovery time | 2021-11-04 | |
MED | IEC 60601-2-47:2012 | 201.12.4.4.102 Input Impedance201.12.4.4.103 Common mode rejection201.12.4.4.104 GAIN accuracy201.12.4.4.105 GAIN stability201.12.4.4.106 System noise201.12.4.4.107 Multichannel crosstalk201.12.4.4.108 Frequency response201.12.4.4.109 Function in the presence of pacemaker pulses201.12.4.4.110 Timing accuracy201.12.4.4.112 Temporal alignment201.15.3.4.2 PORTABLE ME EQUIPMENT - Drop Test201.15.4.3.101.1 Monitoring time201.15.4.3.101.2 Data retention201.12.4.4.101 Linearity and dynamic range201.8.7.1.101 Patient Leakage Current of Type BF and CF Applied Parts 201.8.5.5.1 Defibrillation protection201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT201.11.8.101 Protection against depletion of battery201.15.4.4.101 Indicator of battery operation and battery status208.6.3.3.2.101 Volume of auditory ALARM SIGNALS reducible to zero208.6.8.3.101 Global temporary ALARM SIGNAL inactivation states − Duration of global ALARM PAUSED and AUDIO PAUSED208.6.10 NON-LATCHING and LATCHING ALARM SIGNALS201.8.5.2.3 PATIENT leads | 2021-11-04 | |
MED | IEC 60601-2-49:2011 | 201.8.7.1.101 Patient Leakage Current of Type BF and CF Applied Parts 201.8.5.5.1 Defibrillation protection201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT201.11.8.101 Protection against depletion of battery201.15.4.4.101 Indicator of battery operation and battery status208.6.3.3.2.101 Volume of auditory ALARM SIGNALS reducible to zero208.6.8.3.101 Global temporary ALARM SIGNAL inactivation states − Duration of global ALARM PAUSED and AUDIO PAUSED208.6.10 NON-LATCHING and LATCHING ALARM SIGNALS201.8.5.2.3 PATIENT leads | 2021-11-04 | |
MED | IEC 80601-2-26:2019 | 201.12.1.102 Accuracy of amplitude and rate of variation201.8.5.5.1 Defibrillation protection – Differential mode test201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT201.12.1.103 Input dynamic range and differential offset voltage201.12.1.104 Input noise201.12.1.105 Frequency response201.12.1.106 Common mode rejection202.8.101 Disturbances from HF SURGICAL EQUIPMENT | 2021-11-04 | |
MED | IEC 80601-2-30:2018 | 202.8.101 Electrosurgery interference recovery201.12.1.104 Maximum pressure in normal condition201.12.1.105 Maximum pressure in single fault condition201.12.1.101 Measuring and display ranges201.12.1.102 Limits of the error of the manometer from environmental conditions201.12.1.107 Reproducibility of the BLOOD PRESSURE DETERMINATION201.15.3.5.101a) Shock and vibration for other than transport – shock test201.15.3.5.101b) Shock and vibration for other than transport – vibration test201.104 Maximum inflating time201.11.8 interruption of the power supply/supply mains to ME Equipment201.12.1.103 Nominal blood pressure indication range | 2021-11-04 | |
MED | IEC 80601-2-30:2009 | 202.6.2.101 Electrosurgery interference recovery201.12.1.104 Maximum pressure in normal condition201.12.1.105 Maximum pressure in single fault condition201.12.1.101 Measuring and display ranges201.12.1.102 Limits of the error of the manometer from environmental conditions201.12.1.107 Reproducibility of the BLOOD PRESSURE DETERMINATION201.15.3.5.101a) Shock and vibration for other than transport – shock test201.15.3.5.101b) Shock and vibration for other than transport – vibration test201.104 Maximum inflating time201.11.8 interruption of the power supply/supply mains to ME Equipment201.12.1.103 Nominal blood pressure indication range | 2022-10-05 | |
MED | IEC 80601-2-30:2009/AMD1:2013 | 202.6.2.101 Electrosurgery interference recovery201.12.1.104 Maximum pressure in normal condition201.12.1.105 Maximum pressure in single fault condition201.12.1.101 Measuring and display ranges201.12.1.102 Limits of the error of the manometer from environmental conditions201.12.1.107 Reproducibility of the BLOOD PRESSURE DETERMINATION201.15.3.5.101a) Shock and vibration for other than transport – shock test201.15.3.5.101b) Shock and vibration for other than transport – vibration test201.104 Maximum inflating time201.11.8 interruption of the power supply/supply mains to ME Equipment201.12.1.103 Nominal blood pressure indication range | 2022-10-05 | |
MED | IEC 80601-2-49:2018 | 201.8.5.5.1 Defibrillation protection201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT201.11.8.101 Protection against depletion of the INTERNAL ELECTRICAL POWER SOURCE201.15.101 Display of PATIENT data201.15.4.4.101 "Indicator of operation from the INTERNAL ELECTRICAL POWER SOURCE andthe status of the INTERNAL ELECTRICAL POWER SOURCE"202.8.102 Disturbances from HF SURGICAL EQUIPMENT208.6.3.2.101 Indication of validity of measured values208.6.10 NON-LATCHING and LATCHING ALARM SIGNALS208.6.12 ALARM SYSTEM logging201.8.5.2.3 PATIENT leads | 2021-11-04 | |
MED | ISO 80601-2-55:2018 | 11.6.6 Cleaning and disinfection 201.12.1.101.3 Measurement accuracy of Gas Reading for gas mixtures201.11.6.5 Ingress of water 201.11.8.101.2 Settings and data storage following short interruptions or automatic switchover201.11.8.101.4 RESERVE ELECTRICAL POWER SOURCE201.11.8.101.5 RESERVE ELECTRICAL POWER SOURCE for transport outside a healthcare facility201.12.1.101.1 Measurement accuracy201.12.1.101.2 Drift of Measurement Accuracy201.12.1.102 TOTAL SYSTEM RESPONSE TIME and rise time 201.15.3.5.101.2 a) (Type 1) Shock test (IEC 60068-2-27:2008) for an RGM or its parts not intended for use during professional transport of a patient outside a professional health care facility under the following conditions (Test Type 1):201.15.3.5.101.2 a) (Type 2) Shock test (IEC 60068-2-27:2008) for an RGM or its parts not intended for use during professional transport of a patient outside a professional health care facility under the following conditions (Test Type 2):201.15.3.5.101.2 b) (Broad-band random) Broad-band random Vibration (IEC 60068-2-64:2008) for an RGM or its parts not intended for use during professional transport of a patient outside a professional health care facility under the following conditions (Broad-band random vibration test): 201.102 Gas leakage208.6.1.2 Alarm Condition Priority | 2022-10-05 | |
MED | ISO 80601-2-56:2017 | 201.101.2 Laboratory accuracy201.11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEM201.12.1.101 Additional requirements for accuracy of controls and instruments201.101.3A Time response – heating transient time201.101.3B Time response – cooling transient time | 2022-10-05 | |
MED | ISO 80601-2-56:2017/AMD1:2018 | 201.101.2 Laboratory accuracy201.11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEM201.12.1.101 Additional requirements for accuracy of controls and instruments201.101.3A Time response – heating transient time201.101.3B Time response – cooling transient time | 2022-10-05 | |
MED | ISO 80601-2-61:2017 | 201.11 Protection against excessive temperatures in me equipment 201.11.6.5.101 Ingress of water 201.11.8.101.1 a) Supply failure technical alarm condition201.11.8.101.1 b) Supply failure technical alarm condition201.11.8.101.2 Settings and data storage following short interruptions or automatic switchover201.12.4.101 DATA UPDATE PERIOD201.12.4.102 Signal inadequacy201.13.101 Detection of pulse oximeter probe faults and probe cable extender faults201.15.3.5.101.1 a) ( Type 1) Shock test (IEC 60068-2-27:2008) for an Pulse Oximeter Equipment or its parts not intended for use during professional transport of a patient outside a professional health care facility under the following conditions (Test Type 1):201.15.3.5.101.1 a) (Type 2) Shock test (IEC 60068-2-27:2008) for a Pulse Oximeter Equipment or its parts not intended for use during professional transport of a patient outside a professional health care facility under the following conditions (Test Type 2):201.15.3.5.101.1 b) (Broad-band random) Vibration Test (IEC 60068-2-64:2008) for a Pulse Oximeter Equipment or its parts not intended for use during professional transport of a patient outside a professional health care facility under the following conditions (Broad-band random vibration test):201.103.1 Failure of equipment connected to or disruptions of connections to Signal Input/Output parts201.103.2 Electronic Health Record connection208.6.1.2.101 Alarm Condition Priority208.6.5.4.101 Default Alarm Preset208.6.8.5.101 Alarm Signal Inactivation States, Indication and Access | 2022-10-05 | |
OFF | IEC 60950-1:2005 | 1.6.2 Input Current1.7 Marking legibility and durability2.1.1.1 Access to energized parts2.1.1.5 Energy Hazards2.1.1.6 Manual controls2.1.1.7 Discharge of capacitors in equipment2.1.1.82.2.2, 2.2.3, 2.2.4 SELV RELIABILITY2.3 TNV Circuits2.4 Limited Current Circuits2.5 Limited Power Sources2.6.3.4 Resistance of earthing conductors and their terminations2.9.2 Humidity Conditioning2.10.2 DETERMINATION OF WORKING VOLTAGE - WORKING VOLTAGE MEASUREMENT TEST2.10.3 & 2.10.4 Clearances & Creepage Distances2.10.3.9 Measurement of transient voltages2.10.11 TESTS FOR SEMICONDUCTOR DEVICES AND FOR CEMENTED JOINTS3.1.5, 3.1.9 and 4.2.2 10 N Steady Force Test3.2.5.1 Flex Testing3.2.6 Cord anchorage and strain relief3.2.8 Cord Guards3.3.2 Connection of non-detachable power supply cords3.3.8 Stranded Wire4.1 Stability4.2.3 Steady force test, 30 N4.2.4 Steady state force, 250 N4.2.5 Impact test4.2.6 Drop test4.2.7 Stress relief test4.2.10 Wall or ceiling mounted equipment4.3.2 Handles and manual controls4.3.8 Batteries4.4 Protection against hazardous moving parts4.4.5 Protection against moving fan blades4.5.1, 1.4.12, 1.4.13 HEATING TEST4.5.5 Resistance to abnormal heat (Ball-Pressure)4.6.2 Openings in enclosures - inspection, measurement, and test4.6.5 Adhesives for constructional purposes5.1 Touch current and protective conductor current5.2 Electric strength5.3.4 Abnormal operating and fault conditions - Functional insulation5.3.5 Abnormal operating and fault conditions - Electromechanical components5.3.7 Abnormal operating and fault conditions - Simulation of faults5.3.8 Abnormal operating and fault conditions - Unattended equipmentAnnex DD Requirements for the mounting means of rack-mounted equipment | 2021-11-04 | |
OFF | IEC 60950-1:2005/AMD1:2009 | 1.6.2 Input Current1.7 Marking legibility and durability2.1.1.1 Access to energized parts2.1.1.5 Energy Hazards2.1.1.6 Manual controls2.1.1.7 Discharge of capacitors in equipment2.1.1.82.2.2, 2.2.3, 2.2.4 SELV RELIABILITY2.3 TNV Circuits2.4 Limited Current Circuits2.5 Limited Power Sources2.6.3.4 Resistance of earthing conductors and their terminations2.9.2 Humidity Conditioning2.10.2 DETERMINATION OF WORKING VOLTAGE - WORKING VOLTAGE MEASUREMENT TEST2.10.3 & 2.10.4 Clearances & Creepage Distances2.10.3.9 Measurement of transient voltages2.10.11 TESTS FOR SEMICONDUCTOR DEVICES AND FOR CEMENTED JOINTS3.1.5, 3.1.9 and 4.2.2 10 N Steady Force Test3.2.5.1 Flex Testing3.2.6 Cord anchorage and strain relief3.2.8 Cord Guards3.3.2 Connection of non-detachable power supply cords3.3.8 Stranded Wire4.1 Stability4.2.3 Steady force test, 30 N4.2.4 Steady state force, 250 N4.2.5 Impact test4.2.6 Drop test4.2.7 Stress relief test4.2.10 Wall or ceiling mounted equipment4.3.2 Handles and manual controls4.3.8 Batteries4.4 Protection against hazardous moving parts4.4.5 Protection against moving fan blades4.5.1, 1.4.12, 1.4.13 HEATING TEST4.5.5 Resistance to abnormal heat (Ball-Pressure)4.6.2 Openings in enclosures - inspection, measurement, and test4.6.5 Adhesives for constructional purposes5.1 Touch current and protective conductor current5.2 Electric strength5.3.4 Abnormal operating and fault conditions - Functional insulation5.3.5 Abnormal operating and fault conditions - Electromechanical components5.3.7 Abnormal operating and fault conditions - Simulation of faults5.3.8 Abnormal operating and fault conditions - Unattended equipmentAnnex DD Requirements for the mounting means of rack-mounted equipment | 2021-11-04 | |
OFF | IEC 60950-1:2005/AMD2:2013 | 1.6.2 Input Current1.7 Marking legibility and durability2.1.1.1 Access to energized parts2.1.1.5 Energy Hazards2.1.1.6 Manual controls2.1.1.7 Discharge of capacitors in equipment2.1.1.82.2.2, 2.2.3, 2.2.4 SELV RELIABILITY2.3 TNV Circuits2.4 Limited Current Circuits2.5 Limited Power Sources2.6.3.4 Resistance of earthing conductors and their terminations2.9.2 Humidity Conditioning2.10.2 DETERMINATION OF WORKING VOLTAGE - WORKING VOLTAGE MEASUREMENT TEST2.10.3 & 2.10.4 Clearances & Creepage Distances2.10.3.9 Measurement of transient voltages2.10.11 TESTS FOR SEMICONDUCTOR DEVICES AND FOR CEMENTED JOINTS3.1.5, 3.1.9 and 4.2.2 10 N Steady Force Test3.2.5.1 Flex Testing3.2.6 Cord anchorage and strain relief3.2.8 Cord Guards3.3.2 Connection of non-detachable power supply cords3.3.8 Stranded Wire4.1 Stability4.2.3 Steady force test, 30 N4.2.4 Steady state force, 250 N4.2.5 Impact test4.2.6 Drop test4.2.7 Stress relief test4.2.10 Wall or ceiling mounted equipment4.3.2 Handles and manual controls4.3.8 Batteries4.4 Protection against hazardous moving parts4.4.5 Protection against moving fan blades4.5.1, 1.4.12, 1.4.13 HEATING TEST4.5.5 Resistance to abnormal heat (Ball-Pressure)4.6.2 Openings in enclosures - inspection, measurement, and test4.6.5 Adhesives for constructional purposes5.1 Touch current and protective conductor current5.2 Electric strength5.3.4 Abnormal operating and fault conditions - Functional insulation5.3.5 Abnormal operating and fault conditions - Electromechanical components5.3.7 Abnormal operating and fault conditions - Simulation of faults5.3.8 Abnormal operating and fault conditions - Unattended equipmentAnnex DD Requirements for the mounting means of rack-mounted equipment | 2021-11-04 |