201.4(General requirements) |
- |
50000 |
|
- |
201.5(General requirements for testing ME equipment) |
- |
50000 |
|
- |
201.6(Classification of ME equipment or ME systems) |
- |
50000 |
|
- |
201.7(ME equipment identification, marking and documents) |
- |
50000 |
|
- |
201.8(Protection against electrical hazards from ME equipment) |
- |
50000 |
|
- |
201.9(Protection against mechanical hazards of ME equipment and ME systems) |
- |
50000 |
|
- |
201.10(Protection against unwanted and excessive radiation hazards) |
- |
50000 |
|
- |
201.11(Protection against excessive temperatures and other hazards) |
- |
50000 |
|
- |
201.12(Accuracy of controls and instruments and protection against hazardous outputs) |
- |
50000 |
|
- |
201.13(Hazardous situations and fault conditions) |
- |
50000 |
|
- |
201.14(Programmable electrical medical systems (PEMS)) |
- |
50000 |
|
- |
201.15(Construction of ME equipment) |
- |
50000 |
|
- |
201.16(ME systems) |
- |
50000 |
|
- |
201.101(Additional requirements for anaesthetic gas delivery systems) |
- |
20000 |
|
- |
201.102(Additional requirements for an anaesthetic breathing system) |
- |
20000 |
|
- |
201.103(Additional requirements for an AGSS) |
- |
20000 |
|
- |
201.104(Additional requirements for interchangeable and non-interchangeable anaesthetic vapour delivery systems) |
- |
20000 |
|
- |
201.105(Additional requirements for an anaesthetic ventilator) |
- |
20000 |
|
- |
201.106(Display of pressure-volume loops) |
- |
30000 |
|
- |
201.107(Clinical evaluation) |
- |
40000 |
|
- |
206(Usability) |
- |
40000 |
|
- |
208(General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) |
- |
40000 |
|
- |
201.4(General requirements) |
- |
0 |
|
- |
201.4.4(Additional requirements for expected service life) |
- |
0 |
|
- |
201.4.10(Power supply) |
- |
0 |
|
- |
201.4.10.101(Requirements for pneumatic power input) |
- |
0 |
|
- |
201.5.101.3(Gas flow rate and leakage specifications) |
- |
0 |
|
- |
201.8.11.3(Power supply cords) |
- |
0 |
|
- |
201.9.2.1(General) |
- |
0 |
|
- |
201.9.2.101(Maintenance points) |
- |
0 |
|
- |
201.9.2.102(Lighting) |
- |
0 |
|
- |
201.9.2.103(Integrated seating) |
- |
0 |
|
- |
201.9.2.104(Arrangement of control positions) |
- |
0 |
|
- |
201.9.4(Instability hazards) |
- |
0 |
|
- |
201.9.4.2.4.3(Movement over a threshold) |
- |
0 |
|
- |
201.11.6.3(Spillage on ME equipment and ME systems) |
- |
0 |
|
- |
201.11.6.8(Compatibility with substances used with the ME equipment) |
- |
0 |
|
- |
201.11.8(Interruption of the power supply/supply mains to ME equipment) |
- |
0 |
|
- |
201.11.8.102(Alarm condition for power supply failure) |
- |
0 |
|
- |
201.11.8.103(Internal electrical power source) |
- |
0 |
|
- |
201.11.101(Packaging systems for components intended to be sterilized) |
- |
0 |
|
- |
201.12.4(Protection against hazardous output) |
- |
0 |
|
- |
201.12.4.101(Accidental adjustment of operating controls) |
- |
0 |
|
- |
201.12.4.102(Additional requirements for anaesthetic workstations) |
- |
0 |
|
- |
201.12.4.103(Respiratory gas monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.1(Carbon dioxide monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.2(Oxygen monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.3(Anaesthetic agent monitoring equipment) |
- |
0 |
|
- |
201.12.4.104(Exhaled volume monitoring equipment) |
- |
0 |
|
- |
201.12.4.104.1(Accuracy) |
- |
0 |
|
- |
201.12.4.104.2(Alarm conditions) |
- |
0 |
|
- |
201.12.4.105(Anaesthetic breathing system integrity alarm condition) |
- |
0 |
|
- |
201.12.4.106(Anaesthetic breathing system continuing-positive-pressure alarm condition) |
- |
0 |
|
- |
201.12.4.107.1(Oxygen supply failure alarm system) |
- |
0 |
|
- |
201.12.4.107.2(Oxygen supply failure protection device) |
- |
0 |
|
- |
201.12.4.107.3(Hypoxic mixture delivery selection protection device) |
- |
0 |
|
- |
201.12.4.108(Protection device for the workplace environment) |
- |
0 |
|
- |
201.12.4.109(Protection device for the workplace environment) |
- |
0 |
|
- |
201.13.101(Simultaneous failure) |
- |
0 |
|
- |
201.14.6.1(Identification of known and foreseeable hazards) |
- |
0 |
|
- |
201.14.101(Software life cycle processes) |
- |
0 |
|
- |
201.15.3.5(Rough handling test) |
- |
0 |
|
- |
201.15.101(Operator-detachable, flow-direction-sensitive parts and accessories) |
- |
0 |
|
- |
201.16.9.2.1(Multiple socket-outlet) |
- |
0 |
|
- |
201.16.101.1(General) |
- |
0 |
|
- |
201.16.101.2(Connection to other equipment for network/data coupling) |
- |
0 |
|
- |
201.16.101.3(Connection to distributed alarm system/information system) |
- |
0 |
|
- |
201.101.1.1(Instructions for use) |
- |
0 |
|
- |
201.101.1.2(Technical description) |
- |
0 |
|
- |
201.101.2(Interruption of the electrical power supply) |
- |
0 |
|
- |
201.101.3(Protection against cross-contamination of volatile anaesthetic agents) |
- |
0 |
|
- |
201.101.4(Medical gas supply) |
- |
0 |
|
- |
201.101.4.1.1(Inlet connector) |
- |
0 |
|
- |
201.101.4.1.2(Inlet filtration) |
- |
0 |
|
- |
201.101.4.1.3(Pressure regulators) |
- |
0 |
|
- |
201.101.4.1.4(Reserve oxygen supply) |
- |
0 |
|
- |
201.101.4.2.1(Inlet connector) |
- |
0 |
|
- |
201.101.4.2.2(Inlet filtration) |
- |
0 |
|
- |
201.101.4.2.3(Reverse flow and cross-flow protection device) |
- |
0 |
|
- |
201.101.4.3(Pressure or content monitoring equipment) |
- |
0 |
|
- |
201.101.5.1(Leakage prior to the flow rate adjustment control element) |
- |
0 |
|
- |
201.101.5.2(Leakage after the flow rate adjustment control element) |
- |
0 |
|
- |
201.101.6.1(Graduations and accuracy) |
- |
0 |
|
- |
201.101.6.2(Flow rate adjustment control) |
- |
0 |
|
- |
201.101.6.3(Carbon dioxide flow rate adjustment control) |
- |
0 |
|
- |
201.101.7(Gas mixers) |
- |
0 |
|
- |
201.101.8(Oxygen flush) |
- |
0 |
|
- |
201.101.9(Fresh-gas outlet) |
- |
0 |
|
- |
201.101.10(Interface to interchangeable anaesthetic vapour delivery systems) |
- |
0 |
|
- |
201.102.1.1.1(Non-metallic parts) |
- |
0 |
|
- |
201.102.1.1.2(Bag/ventilator control) |
- |
0 |
|
- |
201.102.1.1.3(Absorbent bypass) |
- |
0 |
|
- |
201.102.1.1.4(Inspiratory and expiratory ports of a circle absorber assembl) |
- |
0 |
|
- |
201.102.1.2(Instructions for use) |
- |
0 |
|
- |
201.102.2(Pressure limitation protection devices) |
- |
0 |
|
- |
201.102.2.1(Maximum limited pressure protection device) |
- |
0 |
|
- |
201.102.2.2(Adjustable pressure limit protection device) |
- |
0 |
|
- |
201.102.3(Packaging of parts of anaesthetic breathing systems) |
- |
0 |
|
- |
201.102.4(Electrical conductivity) |
- |
0 |
|
- |
201.102.5.2(Exhaust port connector) |
- |
0 |
|
- |
201.102.5.1(Patient connection port) |
- |
0 |
|
- |
201.102.5.3.1(Arrangement and connector) |
- |
0 |
|
- |
201.102.5.3.2(Marking) |
- |
0 |
|
- |
201.102.5.3.3(Connectors of the reservoir bag connecting tube) |
- |
0 |
|
- |
201.102.5.4(Anaesthetic ventilator port connector) |
- |
0 |
|
- |
201.102.5.5(Anaesthetic breathing system port connector) |
- |
0 |
|
- |
201.102.5.6(Inspiratory and expiratory port connectors of a circle absorber assembly) |
- |
0 |
|
- |
201.102.5.7(Other port connectors) |
- |
0 |
|
- |
201.102.6(Leakage) |
- |
0 |
|
- |
201.102.7(Inspiratory and expiratory pressure/flow rate characteristics) |
- |
0 |
|
- |
201.102.8.1(Y-piece) |
- |
0 |
|
- |
201.102.8.2(Exhaust valve) |
- |
0 |
|
- |
201.102.8.3(Breathing tubes) |
- |
0 |
|
- |
201.102.9.1(Constructional requirements) |
- |
0 |
|
- |
201.102.9.2(Absorbent bypass mechanism) |
- |
0 |
|
- |
201.102.9.3(Resistance to flow rate) |
- |
0 |
|
- |
201.102.10.2(Opening pressure) |
- |
0 |
|
- |
201.102.10.3(Pressure flow-rate characteristics) |
- |
0 |
|
- |
201.102.10.4(Reverse flow rate and dislocation) |
- |
0 |
|
- |
201.102.11(Fresh-gas inlet) |
- |
0 |
|
- |
201.102.12(Ventilation modes) |
- |
0 |
|
- |
201.103.1.2(Instructions for use) |
- |
0 |
|
- |
201.103.2(Pressure relief protection device) |
- |
0 |
|
- |
201.103.3.1.1(AGSS inlet pressure) |
- |
0 |
|
- |
201.103.3.1.2(Induced flow rate for active AGSS) |
- |
0 |
|
- |
201.103.3.1.3(Flow resistance for active AGSS) |
- |
0 |
|
- |
201.103.3.1.4(Spillage to atmosphere) |
- |
0 |
|
- |
201.103.3.1.5(Leakage) |
- |
0 |
|
- |
201.103.3.2.1(Pressure) |
- |
0 |
|
- |
201.103.3.2.2(Induced flow rate for active AGSS) |
- |
0 |
|
- |
201.103.4.1(Hose connectors) |
- |
0 |
|
- |
201.103.4.2(Connections between parts of transfer systems and receiving systems) |
- |
0 |
|
- |
201.103.4.3(Connections to diverting respiratory gas monitors) |
- |
0 |
|
- |
201.103.5.1(Inlet) |
- |
0 |
|
- |
201.103.6.1(Inlet connectors) |
- |
0 |
|
- |
201.103.6.2(Outlet connectors) |
- |
0 |
|
- |
201.103.6.3(Hoses) |
- |
0 |
|
- |
201.103.6.4(Particle filter for active AGSS) |
- |
0 |
|
- |
201.103.7(Transfer systems and receiving systems with integral power device for active AGSS) |
- |
0 |
|
- |
201.103.8(Visual indicator for active AGSS) |
- |
0 |
|
- |
201.104.1.1(Marking) |
- |
0 |
|
- |
201.104.1.2(Instructions for use) |
- |
0 |
|
- |
201.104.2.1(Controls) |
- |
0 |
|
- |
201.104.2.2(Accuracy) |
- |
0 |
|
- |
201.104.3(Vapour concentration during and after oxygen flush) |
- |
0 |
|
- |
201.104.4(Connectors) |
- |
0 |
|
- |
201.104.5(Cross-contamination) |
- |
0 |
|
- |
201.104.6(Anaesthetic vapour delivery system filling) |
- |
0 |
|
- |
201.105.1(Instructions for use) |
- |
0 |
|
- |
201.105.2(Pressure limitation protection device) |
- |
0 |
|
- |
201.105.2.1(Maximum limited pressure protection device) |
- |
0 |
|
- |
201.105.2.2(Adjustable pressure limit protection device) |
- |
0 |
|
- |
201.105.3(Activation of automatic ventilation) |
- |
0 |
|
- |
201.105.4(Anaesthetic breathing system port connector) |
- |
0 |
|
- |
201.105.5(Interruption of the electrical or pneumatic power supply) |
- |
0 |
|
- |
201.105.6(Exhaust port connector) |
- |
0 |
|
- |
201.105.7.1(Expiratory hold) |
- |
0 |
|
- |
201.105.7.2(Inspiratory hold) |
- |
0 |
|
- |
201.105.8(Subatmospheric pressure) |
- |
0 |
|
- |
206.6.2.2.2(Primary operating functions) |
- |
0 |
|
- |
208.5.2.2(Technical description) |
- |
0 |
|
- |
208.6.8.3(Global indefinite alarm signal inactivation states) |
- |
0 |
|
- |
208.6.8.4(Termination of inactivation of alarm signals) |
- |
0 |
|
- |
208.6.12(Alarm system logging) |
- |
0 |
|
- |
209(Requirements for environmentally conscious design) |
- |
0 |
|
- |
210(Process requirements for the development of physiologic closed-loop controllers) |
- |
0 |
|
- |
211(Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) |
- |
0 |
|
- |
212(Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment) |
- |
0 |
|
- |
BB.2(Spark ignition tests) |
- |
0 |
|
- |
BB.3(Surface temperature ignition tests) |
- |
0 |
|
- |
201.C.1(Marking on the outside of ME equipment and ME systems or their parts) |
- |
0 |
|
- |
201.C.3(Marking of controls and instruments) |
- |
0 |
|
- |
201.C.4(Accompanying documents, general) |
- |
0 |
|
- |
201.C.4(Accompanying documents, technical description) |
- |
0 |
|
- |
201.4(General requirements) |
- |
0 |
|
- |
201.5(General requirements for testing ME equipment) |
- |
0 |
|
- |
201.6(Classification of ME equipment or ME systems) |
- |
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 |
|
- |
201.10(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) |
- |
0 |
|
- |
201.14(Programmable electrical medical systems (PEMS)) |
- |
0 |
|
- |
201.15(Construction of ME equipment) |
- |
0 |
|
- |
201.16(ME systems) |
- |
0 |
|
- |
201.101(Additional requirements for anaesthetic gas delivery systems) |
- |
0 |
|
- |
201.102(Additional requirements for an anaesthetic breathing system) |
- |
0 |
|
- |
201.103(Additional requirements for an AGSS) |
- |
0 |
|
- |
201.104(Additional requirements for interchangeable and non-interchangeable anaesthetic vapour delivery systems) |
- |
0 |
|
- |
201.105(Additional requirements for an anaesthetic ventilator) |
- |
0 |
|
- |
201.106(Display of pressure-volume loops) |
- |
0 |
|
- |
201.107(Clinical evaluation) |
- |
0 |
|
- |
206(Usability) |
- |
0 |
|
- |
208(General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) |
- |
0 |
|
- |
201.4(General requirements) |
- |
0 |
|
- |
201.4.4(Additional requirements for expected service life) |
- |
0 |
|
- |
201.4.10(Power supply) |
- |
0 |
|
- |
201.4.10.101(Requirements for pneumatic power input) |
- |
0 |
|
- |
201.5.101.3(Gas flow rate and leakage specifications) |
- |
0 |
|
- |
201.8.11.3(Power supply cords) |
- |
0 |
|
- |
201.9.2.1(General) |
- |
0 |
|
- |
201.9.2.101(Maintenance points) |
- |
0 |
|
- |
201.9.2.102(Lighting) |
- |
0 |
|
- |
201.9.2.103(Integrated seating) |
- |
0 |
|
- |
201.9.2.104(Arrangement of control positions) |
- |
0 |
|
- |
201.9.4(Instability hazards) |
- |
0 |
|
- |
201.9.4.2.4.3(Movement over a threshold) |
- |
0 |
|
- |
201.11.6.3(Spillage on ME equipment and ME systems) |
- |
0 |
|
- |
201.11.6.8(Compatibility with substances used with the ME equipment) |
- |
0 |
|
- |
201.11.8(Interruption of the power supply/supply mains to ME equipment) |
- |
0 |
|
- |
201.11.8.102(Alarm condition for power supply failure) |
- |
0 |
|
- |
201.11.8.103(Internal electrical power source) |
- |
0 |
|
- |
201.11.101(Packaging systems for components intended to be sterilized) |
- |
0 |
|
- |
201.12.4(Protection against hazardous output) |
- |
0 |
|
- |
201.12.4.101(Accidental adjustment of operating controls) |
- |
0 |
|
- |
201.12.4.102(Additional requirements for anaesthetic workstations) |
- |
0 |
|
- |
201.12.4.103(Respiratory gas monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.1(Carbon dioxide monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.2(Oxygen monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.3(Anaesthetic agent monitoring equipment) |
- |
0 |
|
- |
201.12.4.104(Exhaled volume monitoring equipment) |
- |
0 |
|
- |
201.12.4.104.1(Accuracy) |
- |
0 |
|
- |
201.12.4.104.2(Alarm conditions) |
- |
0 |
|
- |
201.12.4.105(Anaesthetic breathing system integrity alarm condition) |
- |
0 |
|
- |
201.12.4.106(Anaesthetic breathing system continuing-positive-pressure alarm condition) |
- |
0 |
|
- |
201.12.4.107.1(Oxygen supply failure alarm system) |
- |
0 |
|
- |
201.12.4.107.2(Oxygen supply failure protection device) |
- |
0 |
|
- |
201.12.4.107.3(Hypoxic mixture delivery selection protection device) |
- |
0 |
|
- |
201.12.4.108(Protection device for the workplace environment) |
- |
0 |
|
- |
201.12.4.109(Protection device for the workplace environment) |
- |
0 |
|
- |
201.13.101(Simultaneous failure) |
- |
0 |
|
- |
201.14.6.1(Identification of known and foreseeable hazards) |
- |
0 |
|
- |
201.14.101(Software life cycle processes) |
- |
0 |
|
- |
201.15.3.5(Rough handling test) |
- |
0 |
|
- |
201.15.101(Operator-detachable, flow-direction-sensitive parts and accessories) |
- |
0 |
|
- |
201.16.9.2.1(Multiple socket-outlet) |
- |
0 |
|
- |
201.16.101.1(General) |
- |
0 |
|
- |
201.16.101.2(Connection to other equipment for network/data coupling) |
- |
0 |
|
- |
201.16.101.3(Connection to distributed alarm system/information system) |
- |
0 |
|
- |
201.101.1.1(Instructions for use) |
- |
0 |
|
- |
201.101.1.2(Technical description) |
- |
0 |
|
- |
201.101.2(Interruption of the electrical power supply) |
- |
0 |
|
- |
201.101.3(Protection against cross-contamination of volatile anaesthetic agents) |
- |
0 |
|
- |
201.101.4(Medical gas supply) |
- |
0 |
|
- |
201.101.4.1.1(Inlet connector) |
- |
0 |
|
- |
201.101.4.1.2(Inlet filtration) |
- |
0 |
|
- |
201.101.4.1.3(Pressure regulators) |
- |
0 |
|
- |
201.101.4.1.4(Reserve oxygen supply) |
- |
0 |
|
- |
201.101.4.2.1(Inlet connector) |
- |
0 |
|
- |
201.101.4.2.2(Inlet filtration) |
- |
0 |
|
- |
201.101.4.2.3(Reverse flow and cross-flow protection device) |
- |
0 |
|
- |
201.101.4.3(Pressure or content monitoring equipment) |
- |
0 |
|
- |
201.101.5.1(Leakage prior to the flow rate adjustment control element) |
- |
0 |
|
- |
201.101.5.2(Leakage after the flow rate adjustment control element) |
- |
0 |
|
- |
201.101.6.1(Graduations and accuracy) |
- |
0 |
|
- |
201.101.6.2(Flow rate adjustment control) |
- |
0 |
|
- |
201.101.6.3(Carbon dioxide flow rate adjustment control) |
- |
0 |
|
- |
201.101.7(Gas mixers) |
- |
0 |
|
- |
201.101.8(Oxygen flush) |
- |
0 |
|
- |
201.101.9(Fresh-gas outlet) |
- |
0 |
|
- |
201.101.10(Interface to interchangeable anaesthetic vapour delivery systems) |
- |
0 |
|
- |
201.102.1.1.1(Non-metallic parts) |
- |
0 |
|
- |
201.102.1.1.2(Bag/ventilator control) |
- |
0 |
|
- |
201.102.1.1.3(Absorbent bypass) |
- |
0 |
|
- |
201.102.1.1.4(Inspiratory and expiratory ports of a circle absorber assembl) |
- |
0 |
|
- |
201.102.1.2(Instructions for use) |
- |
0 |
|
- |
201.102.2(Pressure limitation protection devices) |
- |
0 |
|
- |
201.102.2.1(Maximum limited pressure protection device) |
- |
0 |
|
- |
201.102.2.2(Adjustable pressure limit protection device) |
- |
0 |
|
- |
201.102.3(Packaging of parts of anaesthetic breathing systems) |
- |
0 |
|
- |
201.102.4(Electrical conductivity) |
- |
0 |
|
- |
201.102.5.2(Exhaust port connector) |
- |
0 |
|
- |
201.102.5.1(Patient connection port) |
- |
0 |
|
- |
201.102.5.3.1(Arrangement and connector) |
- |
0 |
|
- |
201.102.5.3.2(Marking) |
- |
0 |
|
- |
201.102.5.3.3(Connectors of the reservoir bag connecting tube) |
- |
0 |
|
- |
201.102.5.4(Anaesthetic ventilator port connector) |
- |
0 |
|
- |
201.102.5.5(Anaesthetic breathing system port connector) |
- |
0 |
|
- |
201.102.5.6(Inspiratory and expiratory port connectors of a circle absorber assembly) |
- |
0 |
|
- |
201.102.5.7(Other port connectors) |
- |
0 |
|
- |
201.102.6(Leakage) |
- |
0 |
|
- |
201.102.7(Inspiratory and expiratory pressure/flow rate characteristics) |
- |
0 |
|
- |
201.102.8.1(Y-piece) |
- |
0 |
|
- |
201.102.8.2(Exhaust valve) |
- |
0 |
|
- |
201.102.8.3(Breathing tubes) |
- |
0 |
|
- |
201.102.9.1(Constructional requirements) |
- |
0 |
|
- |
201.102.9.2(Absorbent bypass mechanism) |
- |
0 |
|
- |
201.102.9.3(Resistance to flow rate) |
- |
0 |
|
- |
201.102.10.2(Opening pressure) |
- |
0 |
|
- |
201.102.10.3(Pressure flow-rate characteristics) |
- |
0 |
|
- |
201.102.10.4(Reverse flow rate and dislocation) |
- |
0 |
|
- |
201.102.11(Fresh-gas inlet) |
- |
0 |
|
- |
201.102.12(Ventilation modes) |
- |
0 |
|
- |
201.103.1.2(Instructions for use) |
- |
0 |
|
- |
201.103.2(Pressure relief protection device) |
- |
0 |
|
- |
201.103.3.1.1(AGSS inlet pressure) |
- |
0 |
|
- |
201.103.3.1.2(Induced flow rate for active AGSS) |
- |
0 |
|
- |
201.103.3.1.3(Flow resistance for active AGSS) |
- |
0 |
|
- |
201.103.3.1.4(Spillage to atmosphere) |
- |
0 |
|
- |
201.103.3.1.5(Leakage) |
- |
0 |
|
- |
201.103.3.2.1(Pressure) |
- |
0 |
|
- |
201.103.3.2.2(Induced flow rate for active AGSS) |
- |
0 |
|
- |
201.103.4.1(Hose connectors) |
- |
0 |
|
- |
201.103.4.2(Connections between parts of transfer systems and receiving systems) |
- |
0 |
|
- |
201.103.4.3(Connections to diverting respiratory gas monitors) |
- |
0 |
|
- |
201.103.5.1(Inlet) |
- |
0 |
|
- |
201.103.6.1(Inlet connectors) |
- |
0 |
|
- |
201.103.6.2(Outlet connectors) |
- |
0 |
|
- |
201.103.6.3(Hoses) |
- |
0 |
|
- |
201.103.6.4(Particle filter for active AGSS) |
- |
0 |
|
- |
201.103.7(Transfer systems and receiving systems with integral power device for active AGSS) |
- |
0 |
|
- |
201.103.8(Visual indicator for active AGSS) |
- |
0 |
|
- |
201.104.1.1(Marking) |
- |
0 |
|
- |
201.104.1.2(Instructions for use) |
- |
0 |
|
- |
201.104.2.1(Controls) |
- |
0 |
|
- |
201.104.2.2(Accuracy) |
- |
0 |
|
- |
201.104.3(Vapour concentration during and after oxygen flush) |
- |
0 |
|
- |
201.104.4(Connectors) |
- |
0 |
|
- |
201.104.5(Cross-contamination) |
- |
0 |
|
- |
201.104.6(Anaesthetic vapour delivery system filling) |
- |
0 |
|
- |
201.105.1(Instructions for use) |
- |
0 |
|
- |
201.105.2(Pressure limitation protection device) |
- |
0 |
|
- |
201.105.2.1(Maximum limited pressure protection device) |
- |
0 |
|
- |
201.105.2.2(Adjustable pressure limit protection device) |
- |
0 |
|
- |
201.105.3(Activation of automatic ventilation) |
- |
0 |
|
- |
201.105.4(Anaesthetic breathing system port connector) |
- |
0 |
|
- |
201.105.5(Interruption of the electrical or pneumatic power supply) |
- |
0 |
|
- |
201.105.6(Exhaust port connector) |
- |
0 |
|
- |
201.105.7.1(Expiratory hold) |
- |
0 |
|
- |
201.105.7.2(Inspiratory hold) |
- |
0 |
|
- |
201.105.8(Subatmospheric pressure) |
- |
0 |
|
- |
206.6.2.2.2(Primary operating functions) |
- |
0 |
|
- |
208.5.2.2(Technical description) |
- |
0 |
|
- |
208.6.8.3(Global indefinite alarm signal inactivation states) |
- |
0 |
|
- |
208.6.8.4(Termination of inactivation of alarm signals) |
- |
0 |
|
- |
208.6.12(Alarm system logging) |
- |
0 |
|
- |
209(Requirements for environmentally conscious design) |
- |
0 |
|
- |
210(Process requirements for the development of physiologic closed-loop controllers) |
- |
0 |
|
- |
211(Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) |
- |
0 |
|
- |
212(Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment) |
- |
0 |
|
- |
BB.2(Spark ignition tests) |
- |
0 |
|
- |
BB.3(Surface temperature ignition tests) |
- |
0 |
|
- |
201.C.1(Marking on the outside of ME equipment and ME systems or their parts) |
- |
0 |
|
- |
201.C.3(Marking of controls and instruments) |
- |
0 |
|
- |
201.C.4(Accompanying documents, general) |
- |
0 |
|
- |
201.C.4(Accompanying documents, technical description) |
- |
0 |
|
- |
201.4(General requirements) |
- |
0 |
|
- |
201.5(General requirements for testing ME equipment) |
- |
0 |
|
- |
201.6(Classification of ME equipment or ME systems) |
- |
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 |
|
- |
201.10(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) |
- |
0 |
|
- |
201.14(Programmable electrical medical systems (PEMS)) |
- |
0 |
|
- |
201.15(Construction of ME equipment) |
- |
0 |
|
- |
201.16(ME systems) |
- |
0 |
|
- |
201.101(Additional requirements for anaesthetic gas delivery systems) |
- |
0 |
|
- |
201.102(Additional requirements for an anaesthetic breathing system) |
- |
0 |
|
- |
201.103(Additional requirements for an AGSS) |
- |
0 |
|
- |
201.104(Additional requirements for interchangeable and non-interchangeable anaesthetic vapour delivery systems) |
- |
0 |
|
- |
201.105(Additional requirements for an anaesthetic ventilator) |
- |
0 |
|
- |
201.106(Display of pressure-volume loops) |
- |
0 |
|
- |
201.107(Clinical evaluation) |
- |
0 |
|
- |
206(Usability) |
- |
0 |
|
- |
208(General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) |
- |
0 |
|
- |
201.4(General requirements) |
- |
0 |
|
- |
201.4.4(Additional requirements for expected service life) |
- |
0 |
|
- |
201.4.10(Power supply) |
- |
0 |
|
- |
201.4.10.101(Requirements for pneumatic power input) |
- |
0 |
|
- |
201.5.101.3(Gas flow rate and leakage specifications) |
- |
0 |
|
- |
201.8.11.3(Power supply cords) |
- |
0 |
|
- |
201.9.2.1(General) |
- |
0 |
|
- |
201.9.2.101(Maintenance points) |
- |
0 |
|
- |
201.9.2.102(Lighting) |
- |
0 |
|
- |
201.9.2.103(Integrated seating) |
- |
0 |
|
- |
201.9.2.104(Arrangement of control positions) |
- |
0 |
|
- |
201.9.4(Instability hazards) |
- |
0 |
|
- |
201.9.4.2.4.3(Movement over a threshold) |
- |
0 |
|
- |
201.11.6.3(Spillage on ME equipment and ME systems) |
- |
0 |
|
- |
201.11.6.8(Compatibility with substances used with the ME equipment) |
- |
0 |
|
- |
201.11.8(Interruption of the power supply/supply mains to ME equipment) |
- |
0 |
|
- |
201.11.8.102(Alarm condition for power supply failure) |
- |
0 |
|
- |
201.11.8.103(Internal electrical power source) |
- |
0 |
|
- |
201.11.101(Packaging systems for components intended to be sterilized) |
- |
0 |
|
- |
201.12.4(Protection against hazardous output) |
- |
0 |
|
- |
201.12.4.101(Accidental adjustment of operating controls) |
- |
0 |
|
- |
201.12.4.102(Additional requirements for anaesthetic workstations) |
- |
0 |
|
- |
201.12.4.103(Respiratory gas monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.1(Carbon dioxide monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.2(Oxygen monitoring equipment) |
- |
0 |
|
- |
201.12.4.103.3(Anaesthetic agent monitoring equipment) |
- |
0 |
|
- |
201.12.4.104(Exhaled volume monitoring equipment) |
- |
0 |
|
- |
201.12.4.104.1(Accuracy) |
- |
0 |
|
- |
201.12.4.104.2(Alarm conditions) |
- |
0 |
|
- |
201.12.4.105(Anaesthetic breathing system integrity alarm condition) |
- |
0 |
|
- |
201.12.4.106(Anaesthetic breathing system continuing-positive-pressure alarm condition) |
- |
0 |
|
- |
201.12.4.107.1(Oxygen supply failure alarm system) |
- |
0 |
|
- |
201.12.4.107.2(Oxygen supply failure protection device) |
- |
0 |
|
- |
201.12.4.107.3(Hypoxic mixture delivery selection protection device) |
- |
0 |
|
- |
201.12.4.108(Protection device for the workplace environment) |
- |
0 |
|
- |
201.12.4.109(Protection device for the workplace environment) |
- |
0 |
|
- |
201.13.101(Simultaneous failure) |
- |
0 |
|
- |
201.14.6.1(Identification of known and foreseeable hazards) |
- |
0 |
|
- |
201.14.101(Software life cycle processes) |
- |
0 |
|
- |
201.15.3.5(Rough handling test) |
- |
0 |
|
- |
201.15.101(Operator-detachable, flow-direction-sensitive parts and accessories) |
- |
0 |
|
- |
201.16.9.2.1(Multiple socket-outlet) |
- |
0 |
|
- |
201.16.101.1(General) |
- |
0 |
|
- |
201.16.101.2(Connection to other equipment for network/data coupling) |
- |
0 |
|
- |
201.16.101.3(Connection to distributed alarm system/information system) |
- |
0 |
|
- |
201.101.1.1(Instructions for use) |
- |
0 |
|
- |
201.101.1.2(Technical description) |
- |
0 |
|
- |
201.101.2(Interruption of the electrical power supply) |
- |
0 |
|
- |
201.101.3(Protection against cross-contamination of volatile anaesthetic agents) |
- |
0 |
|
- |
201.101.4(Medical gas supply) |
- |
0 |
|
- |
201.101.4.1.1(Inlet connector) |
- |
0 |
|
- |
201.101.4.1.2(Inlet filtration) |
- |
0 |
|
- |
201.101.4.1.3(Pressure regulators) |
- |
0 |
|
- |
201.101.4.1.4(Reserve oxygen supply) |
- |
0 |
|
- |
201.101.4.2.1(Inlet connector) |
- |
0 |
|
- |
201.101.4.2.2(Inlet filtration) |
- |
0 |
|
- |
201.101.4.2.3(Reverse flow and cross-flow protection device) |
- |
0 |
|
- |
201.101.4.3(Pressure or content monitoring equipment) |
- |
0 |
|
- |
201.101.5.1(Leakage prior to the flow rate adjustment control element) |
- |
0 |
|
- |
201.101.5.2(Leakage after the flow rate adjustment control element) |
- |
0 |
|
- |
201.101.6.1(Graduations and accuracy) |
- |
0 |
|
- |
201.101.6.2(Flow rate adjustment control) |
- |
0 |
|
- |
201.101.6.3(Carbon dioxide flow rate adjustment control) |
- |
0 |
|
- |
201.101.7(Gas mixers) |
- |
0 |
|
- |
201.101.8(Oxygen flush) |
- |
0 |
|
- |
201.101.9(Fresh-gas outlet) |
- |
0 |
|
- |
201.101.10(Interface to interchangeable anaesthetic vapour delivery systems) |
- |
0 |
|
- |
201.102.1.1.1(Non-metallic parts) |
- |
0 |
|
- |
201.102.1.1.2(Bag/ventilator control) |
- |
0 |
|
- |
201.102.1.1.3(Absorbent bypass) |
- |
0 |
|
- |
201.102.1.1.4(Inspiratory and expiratory ports of a circle absorber assembl) |
- |
0 |
|
- |
201.102.1.2(Instructions for use) |
- |
0 |
|
- |
201.102.2(Pressure limitation protection devices) |
- |
0 |
|
- |
201.102.2.1(Maximum limited pressure protection device) |
- |
0 |
|
- |
201.102.2.2(Adjustable pressure limit protection device) |
- |
0 |
|
- |
201.102.3(Packaging of parts of anaesthetic breathing systems) |
- |
0 |
|
- |
201.102.4(Electrical conductivity) |
- |
0 |
|
- |
201.102.5.2(Exhaust port connector) |
- |
0 |
|
- |
201.102.5.1(Patient connection port) |
- |
0 |
|
- |
201.102.5.3.1(Arrangement and connector) |
- |
0 |
|
- |
201.102.5.3.2(Marking) |
- |
0 |
|
- |
201.102.5.3.3(Connectors of the reservoir bag connecting tube) |
- |
0 |
|
- |
201.102.5.4(Anaesthetic ventilator port connector) |
- |
0 |
|
- |
201.102.5.5(Anaesthetic breathing system port connector) |
- |
0 |
|
- |
201.102.5.6(Inspiratory and expiratory port connectors of a circle absorber assembly) |
- |
0 |
|
- |
201.102.5.7(Other port connectors) |
- |
0 |
|
- |
201.102.6(Leakage) |
- |
0 |
|
- |
201.102.7(Inspiratory and expiratory pressure/flow rate characteristics) |
- |
0 |
|
- |
201.102.8.1(Y-piece) |
- |
0 |
|
- |
201.102.8.2(Exhaust valve) |
- |
0 |
|
- |
201.102.8.3(Breathing tubes) |
- |
0 |
|
- |
201.102.9.1(Constructional requirements) |
- |
0 |
|
- |
201.102.9.2(Absorbent bypass mechanism) |
- |
0 |
|
- |
201.102.9.3(Resistance to flow rate) |
- |
0 |
|
- |
201.102.10.2(Opening pressure) |
- |
0 |
|
- |
201.102.10.3(Pressure flow-rate characteristics) |
- |
0 |
|
- |
201.102.10.4(Reverse flow rate and dislocation) |
- |
0 |
|
- |
201.102.11(Fresh-gas inlet) |
- |
0 |
|
- |
201.102.12(Ventilation modes) |
- |
0 |
|
- |
201.103.1.2(Instructions for use) |
- |
0 |
|
- |
201.103.2(Pressure relief protection device) |
- |
0 |
|
- |
201.103.3.1.1(AGSS inlet pressure) |
- |
0 |
|
- |
201.103.3.1.2(Induced flow rate for active AGSS) |
- |
0 |
|
- |
201.103.3.1.3(Flow resistance for active AGSS) |
- |
0 |
|
- |
201.103.3.1.4(Spillage to atmosphere) |
- |
0 |
|
- |
201.103.3.1.5(Leakage) |
- |
0.01 |
|
- |
201.103.3.2.1(Pressure) |
- |
0 |
|
- |
201.103.3.2.2(Induced flow rate for active AGSS) |
- |
0 |
|
- |
201.103.4.1(Hose connectors) |
- |
0 |
|
- |
201.103.4.2(Connections between parts of transfer systems and receiving systems) |
- |
0 |
|
- |
201.103.4.3(Connections to diverting respiratory gas monitors) |
- |
0 |
|
- |
201.103.5.1(Inlet) |
- |
0 |
|
- |
201.103.6.1(Inlet connectors) |
- |
0 |
|
- |
201.103.6.2(Outlet connectors) |
- |
0 |
|
- |
201.103.6.3(Hoses) |
- |
0 |
|
- |
201.103.6.4(Particle filter for active AGSS) |
- |
0 |
|
- |
201.103.7(Transfer systems and receiving systems with integral power device for active AGSS) |
- |
0 |
|
- |
201.103.8(Visual indicator for active AGSS) |
- |
0 |
|
- |
201.104.1.1(Marking) |
- |
0 |
|
- |
201.104.1.2(Instructions for use) |
- |
0 |
|
- |
201.104.2.1(Controls) |
- |
0 |
|
- |
201.104.2.2(Accuracy) |
- |
0 |
|
- |
201.104.3(Vapour concentration during and after oxygen flush) |
- |
0 |
|
- |
201.104.4(Connectors) |
- |
0 |
|
- |
201.104.5(Cross-contamination) |
- |
0 |
|
- |
201.104.6(Anaesthetic vapour delivery system filling) |
- |
0 |
|
- |
201.105.1(Instructions for use) |
- |
0 |
|
- |
201.105.2(Pressure limitation protection device) |
- |
0 |
|
- |
201.105.2.1(Maximum limited pressure protection device) |
- |
0 |
|
- |
201.105.2.2(Adjustable pressure limit protection device) |
- |
0 |
|
- |
201.105.3(Activation of automatic ventilation) |
- |
0 |
|
- |
201.105.4(Anaesthetic breathing system port connector) |
- |
0 |
|
- |
201.105.5(Interruption of the electrical or pneumatic power supply) |
- |
0 |
|
- |
201.105.6(Exhaust port connector) |
- |
0 |
|
- |
201.105.7.1(Expiratory hold) |
- |
0 |
|
- |
201.105.7.2(Inspiratory hold) |
- |
0 |
|
- |
201.105.8(Subatmospheric pressure) |
- |
0 |
|
- |
206.6.2.2.2(Primary operating functions) |
- |
0 |
|
- |
208.5.2.2(Technical description) |
- |
0 |
|
- |
208.6.8.3(Global indefinite alarm signal inactivation states) |
- |
0 |
|
- |
208.6.8.4(Termination of inactivation of alarm signals) |
- |
0 |
|
- |
208.6.12(Alarm system logging) |
- |
0 |
|
- |
209(Requirements for environmentally conscious design) |
- |
0 |
|
- |
210(Process requirements for the development of physiologic closed-loop controllers) |
- |
0 |
|
- |
211(Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment) |
- |
0 |
|
- |
212(Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment) |
- |
0 |
|
- |
BB.2(Spark ignition tests) |
- |
0 |
|
- |
BB.3(Surface temperature ignition tests) |
- |
0 |
|
- |
201.C.1(Marking on the outside of ME equipment and ME systems or their parts) |
- |
0 |
|
- |
201.C.3(Marking of controls and instruments) |
- |
0 |
|
- |
201.C.4(Accompanying documents, general) |
- |
0 |
|
- |
201.C.4(Accompanying documents, technical description) |
- |
0 |
|
- |