BMC (Tianjin) Medical Co., Ltd.
BMC (Tianjin) Medical Co., Ltd.
| Address(es) |
|
| Website | Not available |
| Status | MEMBER |
| Acceptance date | 2023-06-29 |
Further information
Stage | Country | Name |
|---|---|---|
1 | Belgium |
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 | ISO 80601-2-70:2020 | Accepted clauses: 201.9.6.2.1.101 Additional requirements for audible acoustic energy 201.11.1.2.2 Applied parts not intended to supply heat to a patient 201.12.1.101 Stability of static airway pressure accuracy (long-term accuracy) 201.12.1.102 Stability of dynamic airway pressure accuracy (short-term accuracy) 201.12.1.103Maximum flowrate 201.12.4.101 Measurement of airway pressure 201.12.4.102 Maximum limited pressure protection device 201.12.4.103 CO2 rebreathing | 2023-06-13 | |
MED | ISO 80601-2-74:2021 | Accepted clauses: 201.9.6.2.1.101 Additional requirements for audible acoustic energy 201.11.1.2.2 Applied parts not intended to supply heat to a patient 201.12.1.101 Humidification output 201.12.1.102 Measured gas temperature alarm condition 201.12.1.103 Measured gas temperature monitoring equipment 201.12.1.104 Static temperature stability 201.12.4.101 Thermal overshoot 201.12.4.102 Low humidification output alarm condition 201.13.1.101 Additional specific hazardous situations | 2023-06-13 | |
MED | ISO 80601-2-90:2021 | Accepted clauses: 201.4.11.101.1 overpressure requirement 201.4.11.101.2 Compatibility requirement 201.9.6.2.1.101 Additional requirements for audible acoustic energy 201.11.1.2.2 Applied parts not intended to supply heat to a patient 201.12.1.101.1 Flowrate accuracy 201.12.1.101.2 Accuracy of delivered oxygen concentration 201.12.2.101 Usability of ME equipment 201.12.4.101 Oxygen monitor 201.12.4.102 Maximum limited pressure protection device 201.12.4.103 Flowrate monitoring | 2023-06-13 |