Löwenstein Medical SE & Co. KG
Löwenstein Medical SE & Co. KG
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2021-07-07 |
Further information
Stage | Country | Name |
|---|---|---|
1 | 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 | only 13.2 Single fault conditions | 2021-07-07 | |
MED | IEC 60601-1:2005/AMD1:2012 | only 13.2 Single fault conditions | 2021-07-07 | |
MED | IEC 60601-1:2005/AMD2:2020 | 13.2 Single fault conditions | 2023-09-20 | |
MED | ISO 80601-2-12:2020 | 201.4.11.101.2 Input flow201.9.201 Suction procedures201.12.1.101 Accuracy of volume-controlledventilation201.12.1.102 Accuracy of pressure-controlledventilation201.12.1.103 Accuracy of other inflation-types201.12.1.104 Inspiratory volume monitoring201.12.1.105 O2 concentration change test201.12.4.103 Measurement of exhaled volume andalarm conditions for too small volume | 2023-09-20 | |
MED | ISO 80601-2-13:2011 | clauses201.4.101.101 Input flow201.12.4.104.1 Accuracy of exhaled volume monitoring201.12.4.109 Accuracy of airway pressure monitoring201.101.6.1 Graduation of flow controls201.101.7 Oxygen concentration201.104.2.2 Accuracy of delivered concentration201.104.3 Delivered concentration during and after oxygen flush | 2021-07-07 | |
MED | ISO 80601-2-55:2018 | 201.12.1.101.1 Measurement accuracy201.12.1.101.2 Drift of measurement accuracy201.12.1.102 Total system response time and risetime | 2023-09-20 | |
MED | ISO 80601-2-87:2021 | 201.4.11.101.2 Input flow201.9.201 Suction procedures201.12.1.101 Accuracy of mean airway pressure201.12.1.103 FiO2 concentration201.12.1.104 O2 concentration change test201.12.4.102 Measurement of mean airway pressureand pressure amplitude201.12.4.104 Measurement of pressure amplitude andlow and high pressure amplitude alarm conditions | 2023-09-20 | |
MED | ISO 80601-2-90:2021 | 201.12.1.101.1 Flowrate accuracy201.12.1.101.2 Accuracy of delivered oxygenconcentration | 2023-09-20 |