| 201.4(Power and Current) |
- |
50000 |
|
- |
| 201.5(Temperature, Humidity, Dimensions, Force) |
- |
50000 |
|
- |
| 201.7.1.2(Legibility of markings) |
- |
30000 |
|
- |
| 201.8(Current, Voltage, Energy, Dimensions, Impedance) |
- |
70000 |
|
- |
| 201.9(Mechanical dimensions, strength , torque, force) |
- |
50000 |
|
- |
| 201.9.6.2.1.101(Additional requirements for audible acoustic energy) |
- |
0 |
|
- |
| 201.11(Protection against excessive temperatures and other HAZARDS) |
- |
20000 |
|
- |
| 201.11.1(Maximum temperature during NORMAL USE) |
- |
10000 |
|
- |
| "201.11. 1.2.2"(APPLIED PARTS not intended to supply heat to a PATIENT) |
- |
10000 |
|
- |
| 201.11.2.101(Additional requirements for fire prevention) |
- |
0 |
|
- |
| 201.11.6.7(Leakage currents , dielectirc strength) |
- |
10000 |
|
- |
| "201.11. 8.101"() |
- |
0 |
|
- |
| 201.11.8.101.1(TECHNICAL ALARM CONDITION for power supply failure) |
- |
10000 |
|
- |
| 201.11.8.101.2(INTERNAL ELECTRICAL POWER SOURCE) |
- |
0 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
10000 |
|
- |
| "201.12. 1"(Legibility of markings) |
- |
10000 |
|
- |
| 201.12.1.101(Flowrate control) |
- |
10000 |
|
- |
| 201.12.1.103(Accuracy of concentration) |
- |
10000 |
|
- |
| 201.12.1.104(Outlet pressure) |
- |
10000 |
|
- |
| 201.12.4.4.101.2(Indication of start-up period) |
- |
5000 |
|
- |
| 201.12.4.102(Low oxygen concentration ALARM CONDITION) |
- |
10000 |
|
- |
| 201.13(HAZARDOUS SITUATIONS and fault conditions) |
- |
20000 |
|
- |
| 201.13.2.101(Additional specific SINGLE FAULT CONDITIONS) |
- |
10000 |
|
- |
| 201.15(Mechanical strength, Temperature, current) |
- |
50000 |
|
- |
| 201.16(Leakage currents , dielectirc strength) |
- |
30000 |
|
- |
| 201.17(Electromagnetic compatibility) |
- |
0 |
|
Excluded |
| 201.102.3(Fire RISK reduction in ACCESSORIES) |
- |
0 |
|
- |
| 202(Electromagnetic disturbances - Requirements and tests) |
- |
0 |
|
Excluded |
| 211(Temperature, humidity, altitude, IP, Vibration, Mechanical shock) |
- |
0 |
|
- |
| 201.7(ME equipment identification, marking and documents) |
- |
0 |
|
- |
| 201.10(Protection against unwanted and excessive radiaton hazards) |
- |
0 |
|
- |
| 201.12.4.103(Filter for the delivered gas) |
- |
0 |
|
- |
| 201.12.4.4.101.1(Flowrate control) |
- |
0 |
|
- |
| 201.12.1.102(Accuracy of triggered flow) |
- |
0 |
|
- |
| 201.11.7(Biocompatibility of ME equipment and ME systems) |
- |
0 |
|
- |
| 12.11.6.6(Cleaning and disinfection of ME equipment or ME system) |
- |
0 |
|
- |
| 201.11.3.101(Additional requirements for fire enclosures of ME equipment) |
- |
0 |
|
- |
| 201.6(Classification of ME equipment and ME systems) |
- |
0 |
|
- |
| 201.6(General requirements) |
- |
0 |
|
- |
| 201.5(General requirements for testing of ME equipment) |
- |
0 |
|
- |
| 201.4(General requirements) |
- |
0 |
|
- |
| 201.7(ME equipment identification, marking and documents) |
- |
0 |
|
- |
| 201.8(Protection against electrical hazards from ME equipment) |
- |
0 |
|
- |
| 201.9(Protection against mechanical hazards of ME equipment and ME systems) |
- |
0 |
|
- |
| 201.1(Protection against unwanted and excessive radiation hazards) |
- |
0 |
|
- |
| 201.11(Protection against excessive temperatures and other hazards) |
- |
0 |
|
- |
| 201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
0 |
|
- |
| 201.13(Hazardous situations and fault conditions for ME equipment) |
- |
0 |
|
- |
| 201.14(Programmable electrical medical systems (PEMS)) |
- |
0 |
|
- |
| 201.14(Programmable electrical medical systems (PEMS)) |
- |
0 |
|
- |
| 201.16(ME systems) |
- |
0 |
|
- |
| 201.17(Electromagnetic compatibility of ME equipment and ME systems) |
- |
0 |
|
- |
| 201.101(Outlet connector) |
- |
0 |
|
- |
| 201.102(Requirements for parts and accessories) |
- |
0 |
|
- |
| 201.103(Functional connection) |
- |
0 |
|
- |
| 201.104(Indication of duration of operation) |
- |
0 |
|
- |
| 201.105(Integrated conserving equipment function) |
- |
0 |
|
- |
| 202(Electromagnetic disturbances – Requirements and tests) |
- |
0 |
|
- |
| 211(Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) |
- |
0 |
|
- |
