Philips Medical Systems Andover Standards and Reliability Center
Philips Medical Systems Andover Standards and Reliability Center
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2023-12-13 |
Further information
Stage | Country | Name |
|---|---|---|
2 | 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 | Compliance testing of patient monitoring equipment. Accepted clauses: 11.6.5 Ingress of water IPX1 and IPX2 | 2023-12-13 | |
MED | IEC 60601-1:2005/AMD1:2012 | Compliance testing of patient monitoring equipment. Accepted clauses: 11.6.5 Ingress of water IPX1 and IPX2 | 2023-12-13 | |
MED | IEC 60601-1:2005/AMD2:2020 | Compliance testing of patient monitoring equipment. Accepted clauses: 11.6.5 Ingress of water IPX1 and IPX2 | 2023-12-13 | |
MED | IEC 60601-1-6:2010 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-6:2010/AMD1:2013 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-6:2010/AMD2:2020 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-8:2006 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-8:2006/AMD1:2012 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-8:2006/AMD2:2020 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-9:2007 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-9:2007/AMD1:2013 | All clauses | 2023-12-13 | |
MED | IEC 60601-1-9:2007/AMD2:2020 | All clauses | 2023-12-13 | |
MED | IEC 60601-2-25:2011 | Compliance testing of patient monitoring equipment including or in combination with electrocardiographs measurement. Accepted clauses: 201.12.4.102.3 Test of LEAD networks, 201.12.4.103 Input impedance, 201.12.4.105.1 Common mode rejection, 201.12.4.106.1 Noise Level, 201.12.4.106.2 Channel crosstalk, 201.12.4.107.2 Linearity and dynamic range201.12.4.108.3.2 Recordings speed, 201.12.4.109 Use with Cardiac Pacemaker202.6.2.101 Electrosurgery interference. | 2023-12-13 | |
MED | IEC 60601-2-26:2012 | All clauses | 2023-12-13 | |
MED | IEC 60601-2-27:2011 | Compliance testing of patient monitoring equipment including or in combination with electrocardiographic monitoring equipment. Accepted clauses: 201.12.1.101.1 Accuracy of signal reproduction, 201.12.1.101.2 Input dynamic range and differential offset voltage, 201.12.1.101.3 Input impedance, 201.12.1.101.4 Input Noise, 201.12.1.101.5 Multi-channel crosstalk, 201.12.1.101.6 Gain control and stability, 201.12.1.101.7 SWEEP SPEED, 201.12.1.101.8 Frequency response, 201.12.1.101.9 Gain Indicator, 201.12.1.101.10 Common mode rejection, 201.12.1.101.11 Baseline reset, 201.12.1.101.12 Pacemaker pulse display capability, 201.12.1.101.13 Rejection of pacemaker pulses, 201.12.1.101.14 Synchronizing pulse for cardioversion, 201.12.1.101.15 Accuracy of Detected Heart Rate, 201.12.1.101.16 Output display, 201.12.1.101.17 Tall T-wave rejection capability, 202.6.2.101 Means provided for protection against malfunction caused by electrosurgery. | 2023-12-13 | |
MED | IEC 60601-2-34:2011 | Compliance testing of patient monitoring equipment including or in combination with invasive blood pressure monitoring equipment. Accepted clauses: 201.12.1.101 Accuracy of pressure measurement, 202.6.2.101 Electrosurgery interference, 208.6.6.2.101 Physiological ALARM CONDITIONS, ALARM LIMITS and delay time of physiological ALARM SIGNALS, 208.6.6.2.102 Detection of TRANSDUCER and TRANSDUCER cable fault, 208.6.6.2.103 Detection of disconnected catheter. | 2023-12-13 | |
MED | IEC 60601-2-37:2007 | All clauses except 201.12 Accuracy of controls and instruments and protection against hazardous outputs | 2023-12-13 | |
MED | IEC 60601-2-37:2007/AMD1:2015 | All clauses except 201.12 Accuracy of controls and instruments and protection against hazardous outputs | 2023-12-13 | |
MED | IEC 60601-2-49:2011 | All clauses | 2023-12-13 | |
MED | IEC 80601-2-26:2019 | All clauses | 2023-12-13 | |
MED | IEC 80601-2-30:2018 | Compliance testing of patient monitoring equipment including or in combination with non-invasive sphygmomanometers. Accepted clauses: 201.11.8 Interruption of the power supply/supply mains to ME Equipment, 201.12.1.101 Measuring and display ranges, 201.12.1.102 Limits of the error of the manometer from environmental conditions, 201.12.1.103 Nominal blood pressure indication range, 201.12.1.104 Maximum pressure in normal condition, 201.12.1.105 Maximum pressure in single fault condition, 201.12.1.106 Manometer test mode, 201.12.1.107 Reproducibility of the blood pressure determination, 201.104 Maximum inflating time, 201.105 Automated cycling modes, 201.106 Clinical accuracy, 202.6.2.101 Electrosurgery interference recovery. | 2023-12-13 | |
MED | IEC 80601-2-30:2009 | Compliance testing of patient monitoring equipment including or in combination with non-invasive sphygmomanometers. Accepted clauses: 201.11.8 Interruption of the power supply/supply mains to ME Equipment, 201.12.1.101 Measuring and display ranges, 201.12.1.102 Limits of the error of the manometer from environmental conditions, 201.12.1.103 Nominal blood pressure indication range, 201.12.1.104 Maximum pressure in normal condition, 201.12.1.105 Maximum pressure in single fault condition, 201.12.1.106 Manometer test mode, 201.12.1.107 Reproducibility of the blood pressure determination, 201.104 Maximum inflating time, 201.105 Automated cycling modes, 201.106 Clinical accuracy, 202.6.2.101 Electrosurgery interference recovery. | 2023-12-13 | |
MED | IEC 80601-2-30:2009/AMD1:2013 | Compliance testing of patient monitoring equipment including or in combination with non-invasive sphygmomanometers. Accepted clauses: 201.11.8 Interruption of the power supply/supply mains to ME Equipment, 201.12.1.101 Measuring and display ranges, 201.12.1.102 Limits of the error of the manometer from environmental conditions, 201.12.1.103 Nominal blood pressure indication range, 201.12.1.104 Maximum pressure in normal condition, 201.12.1.105 Maximum pressure in single fault condition, 201.12.1.106 Manometer test mode, 201.12.1.107 Reproducibility of the blood pressure determination, 201.104 Maximum inflating time, 201.105 Automated cycling modes, 201.106 Clinical accuracy, 202.6.2.101 Electrosurgery interference recovery. | 2023-12-13 | |
MED | IEC 80601-2-49:2018 | All clauses | 2023-12-13 |