Philips Medizin Systeme Böblingen GmbH
Philips Medizin Systeme Böblingen GmbH
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2006-06-28 |
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 |
|---|---|---|---|---|
EMC | IEC 60601-1-2:2014 | All clauses | 2019-07-31 | |
MED | IEC 60601-1:2005 | Compliance testing of patient monitoring equipment according the following clause: 11.6.5 Ingress of water IPX1 and IPX2 | 2019-07-31 | |
MED | IEC 60601-1:2005/AMD1:2012 | Compliance testing of patient monitoring equipment according the following clause: 11.6.5 Ingress of water IPX1 and IPX2 | 2019-07-31 | |
MED | IEC 60601-1:2005/AMD2:2020 | Compliance testing of patient monitoring equipment according the following clause: 11.6.5 Ingress of water IPX1 and IPX2 | 2022-11-13 | |
MED | IEC 60601-1-4:1996 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-4:1996/AMD1:1999 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-6:2010 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-6:2010/AMD1:2013 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-6:2010/AMD2:2020 | All clauses | 2022-11-13 | |
MED | IEC 60601-1-8:2006 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-8:2006/AMD1:2012 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-8:2006/AMD2:2020 | All clauses | 2022-11-13 | |
MED | IEC 60601-1-9:2007 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-9:2007/AMD1:2013 | All clauses | 2019-07-31 | |
MED | IEC 60601-1-9:2007/AMD2:2020 | All clauses | 2022-11-13 | |
MED | IEC 60601-2-13:2003 | All clauses | 2019-07-31 | |
MED | IEC 60601-2-13:2003/AMD1:2006 | All clauses | 2019-07-31 | |
MED | IEC 60601-2-23:2011 | Compliance testing of patient monitoring equipment including or in combination with transcutaneous partial pressure monitoring equipment according the following clauses: 201.12.1.101.1 Non-linearity and hysteresis | 2019-07-31 | |
MED | IEC 60601-2-25:2011 | Compliance testing of patient monitoring equipment including or in combination with electrocardiographs measurement according following 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 range; 201.12.4.108.3.2 Recordings speed; 202.6.2.101 Electrosurgery interference | 2019-07-31 | |
MED | IEC 60601-2-26:2012 | All clauses | 2019-07-31 | |
MED | IEC 60601-2-27:2011 | Compliance testing of patient monitoring equipment including or in combination with electrocardiographic monitoring equipment according following 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 201.12.1.101.12 Pacemaker pulse display capability 201.12.1.101.13 Rejection of pacemaker pulses 201.12.1.101.15 Accuracy of Detected Heart Rate 201.12.1.101.16 Output display 202.6.2.101 Means provided for protection against malfunction caused by electrosurgery | 2019-07-31 | |
MED | IEC 60601-2-34:2011 | Compliance testing of patient monitoring equipment including or in combination with invasive blood pressure monitoring equipment according the following clauses: 201.12.1.101 Accuracy of pressure measurement 208.6.6.2.101 ALARM LIMITS and delay time of physiological ALARM SIGNALS 208.6.6.2.102 Alarm condition delay/Technical alarm conditions | 2019-07-31 | |
MED | IEC 60601-2-37:2007 | All clauses | 2019-07-31 | |
MED | IEC 60601-2-37:2007/AMD1:2015 | All clauses | 2019-07-31 | |
MED | IEC 60601-2-49:2011 | All clauses | 2019-07-31 | |
MED | IEC 80601-2-26:2019 | All clauses | 2021-07-21 | |
MED | IEC 80601-2-30:2018 | Compliance testing of patient monitoring equipment including or in combination with non-invasive sphygmomanometers according following clauses: 201.11.8 Interruption of the power supply/supply mains to ME Equipment 201.12.1.101 Measuring and display ranges 201.12.1.103 Nominal blood pressure indication range 201.12.1.104 Maximum pressure in normal condition 201.12.1.105 Maximum pressure in single fault condition 201.104 Maximum inflating time 201.105 Automated cycling modes 201.106 Clinical accuracy 202.6.2.101 Electosurgery interference recovery | 2019-07-31 | |
MED | IEC 80601-2-49:2018 | All clauses | 2019-07-31 | |
MED | ISO 80601-2-13:2011 | Compliance testing of patient monitoring equipment intended for use in combination with anaesthetic workstation or as monitoring device according following clauses: 201.12.4.104.1 Accuracy of exhaled volume monitoring; 201.12.4.109 Accuracy of airway pressure monitoring | 2021-07-21 | |
MED | ISO 80601-2-13:2011/AMD1:2015 | Compliance testing of patient monitoring equipment intended for use in combination with anaesthetic workstation or as monitoring device according following clauses: 201.12.4.104.1 Accuracy of exhaled volume monitoring; 201.12.4.109 Accuracy of airway pressure monitoring | 2021-07-21 | |
MED | ISO 80601-2-55:2018 | Compliance testing of patient monitoring equipment including or in combination with respiratory gas monitors according the following clauses: 201.12.1.101 Measurement accuracy 201.12.1.102 Total System response time and rise time | 2019-07-31 | |
MED | ISO 80601-2-55:2011 | Compliance testing of patient monitoring equipment including or in combination with respiratory gas monitors according the following clauses: 201.12.1.101 Measurement accuracy 201.12.1.102 Total System response time and rise time | 2019-07-31 | |
MED | ISO 80601-2-56:2017 | Compliance testing of patient monitoring equipment including or in combination with clinical thermometers for body temperature measurement according the following clauses: 201.101.2 Laboratory accuracy 201.101.3 Time response 201.102.1 Clinical accuracy validation | 2019-07-31 | |
MED | ISO 80601-2-56:2017/AMD1:2018 | Compliance testing of patient monitoring equipment including or in combination with clinical thermometers for body temperature measurement according the following clauses: 201.101.2 Laboratory accuracy 201.101.3 Time response 201.102.1 Clinical accuracy validation | 2021-07-21 | |
MED | ISO 80601-2-56:2009 | Compliance testing of patient monitoring equipment including or in combination with clinical thermometers for body temperature measurement according the following clauses: 201.101.2 Laboratory accuracy 201.101.3 Time response 201.102.1 Clinical accuracy validation | 2019-07-31 | |
MED | ISO 80601-2-61:2017 | Compliance testing of patient monitoring equipment including or in combination with clinical thermometers for body temperature measurement according the following clauses: 201.12. Accuracy 201.13.101 Detection of Pulse Oximeter Probe faults and probe cable extender faults | 2019-07-31 | |
MED | ISO 80601-2-61:2011 | Compliance testing of patient monitoring equipment including or in combination with clinical thermometers for body temperature measurement according the following clauses: 201.12. Accuracy 201.13.101 Detection of Pulse Oximeter Probe faults and probe cable extender faults | 2019-07-31 |