BS EN ISO 80601-2-13:2012:2013 Edition
$215.11
Medical electrical equipment – Particular requirements for basic safety and essential performance of an anaesthetic workstation
| Published By | Publication Date | Number of Pages |
| BSI | 2013 | 116 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
| 41 | 201.101 Additional requirements for anaesthetic gas delivery 201.101.1 Identification and documents 201.101.1.1 Instructions for use |
| 42 | 201.101.1.2 Technical description 201.101.2 * Interruption of the electrical power supply 201.101.3 Protection against cross-contamination of volatile 201.101.4 Medical gas supply 201.101.4.1 Cylinder supplies 201.101.4.1.1 Inlet connector |
| 43 | 201.101.4.1.2 Inlet filtration 201.101.4.1.3 Pressure regulators 201.101.4.1.4 * Reserve oxygen supply 201.101.4.2 Pipeline supplies 201.101.4.2.1 Inlet connector 201.101.4.2.2 Inlet filtration 201.101.4.2.3 Reverse flow and cross-flow protection device |
| 44 | 201.101.4.3 Pressure or content monitoring equipment 201.101.5 Anaesthetic gas delivery system leakage 201.101.5.1 Leakage prior to the flow rate adjustment contro 201.101.5.2 Leakage after the flow rate adjustment control e 201.101.6 Gas flow rate metering 201.101.6.1 Graduations and accuracy |
| 45 | 201.101.6.2 Flow rate adjustment control |
| 46 | 201.101.6.3 * Carbon dioxide flow rate adjustment control 201.101.7 Gas mixers 201.101.8 * Oxygen flush |
| 47 | 201.101.9 * Fresh-gas outlet 201.102 Additional requirements for an anaesthetic breathing 201.102.1 Identification, marking and documents 201.102.1.1 Marking 201.102.1.1.1 Non-metallic components 201.102.1.1.2 Bag/ventilator control 201.102.1.1.3 Absorbent bypass |
| 48 | 201.102.1.1.4 Inspiratory and expiratory ports of a circle a 201.102.1.2 Instructions for use |
| 49 | 201.102.2 Pressure limitation protection device 201.102.2.1 * Maximum limited pressure protection device 201.102.2.2 * Adjustable pressure limitation protection devi 201.102.3 anaesthetic breathing system component packaging 201.102.4 * Electrical conductivity 201.102.5 Connection ports 201.102.5.1 Patient connection port 201.102.5.2 Exhaust port connector |
| 50 | 201.102.5.3 * Reservoir bag connection port 201.102.5.4 Anaesthetic ventilator port connector 201.102.5.5 anaesthetic breathing system component port conn 201.102.5.6 * Inspiratory and expiratory port connectors of |
| 51 | 201.102.5.7 Other port connectors 201.102.6 * Leakage 201.102.7 * Inspiratory and expiratory pressure/flow rate ch 201.102.8 Anaesthetic breathing system components 201.102.8.1 * Y-piece 201.102.8.2 * Exhaust valve |
| 52 | 201.102.9 Circle absorber assemblies 201.102.9.1 * Constructional requirements 201.102.9.2 * Absorbent bypass mechanism 201.102.9.3 Resistance to flow rate |
| 53 | 201.102.10 Inspiratory and expiratory valves 201.102.10.1 * Constructional requirements 201.102.10.2 Opening pressure 201.102.10.3 Pressure flow-rate characteristics |
| 54 | 201.102.10.4 * Reverse flow rate and dislocation 201.102.11 * Fresh-gas inlet 201.103 Additional requirements for an anaesthetic gas scave 201.103.1 Identification, marking and documents 201.103.1.1 Marking 201.103.1.2 Instructions for use 201.103.2 Pressure relief protection device |
| 55 | 201.103.3 Basic requirements 201.103.3.1 Normal condition 201.103.3.1.1 Anaesthetic gas scavenging system inlet pressu 201.103.3.1.2 Induced flow rate 201.103.3.1.3 Flow resistance |
| 56 | 201.103.3.1.5 Leakage 201.103.3.2 Single fault condition 201.103.3.2.1 Pressure 201.103.3.2.2 Induced flow rate 201.103.3.2.3 Subatmospheric pressure at the input of the re 201.103.4 Connectors 201.103.4.1 Hose connectors 201.103.4.2 Connections between parts of transfer systems an |
| 57 | 201.103.4.3 Connections to diverting respiratory gas monitor 201.103.5 Transfer system 201.103.5.1 Inlet 201.103.5.2 Outlet 201.103.6 Receiving system 201.103.6.1 Inlet connectors 201.103.6.2 * Outlet connectors |
| 58 | 201.103.6.3 Hoses 201.103.6.4 Particle filter 201.103.7 Transfer systems and receiving systems with integr 201.103.8 Visual indicator 201.104 Additional requirements for an anaesthetic vapour de 201.104.1 Identification, marking and documents 201.104.1.1 * Marking |
| 59 | 201.104.1.2 Instructions for use 201.104.2 Delivered vapour concentration 201.104.2.1 Controls |
| 60 | 201.104.2.2 * Accuracy |
| 61 | 201.104.3 * Vapour output during and after oxygen flush 201.104.4 Connectors |
| 62 | 201.104.5 Cross-contamination 201.104.6 Anaesthetic vapour delivery system filling 201.104.7 Anaesthetic vapour delivery system component packa 201.105 Additional requirements for an anaesthetic ventilato 201.105.1 Instructions for use |
| 63 | 201.105.2 Pressure limitation protection device 201.105.2.1 Maximum limited pressure protection device 201.105.2.2 * Adjustable pressure limitation protection devi |
| 64 | 201.105.3 Activation of automatic ventilation 201.105.4 Breathing system connection port 201.105.5 Interruption of the electrical or pneumatic power 201.105.6 Exhaust port connector |
| 65 | 201.105.7 * Timed ventilatory pause 201.105.7.1 Expiratory pause 201.105.7.2 Inspiratory pause |
| 66 | 201.105.8 * Subatmospheric pressure |
| 68 | 201.106 Display loops 201.106.1 Pressure-volume loops 201.106.2 Flow-volume loops |
| 94 | Subclause 201.101.4.1.4 Reserve oxygen supply |
