BSI 18/30383266 DC:2018 Edition
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BS EN ISO 80601-2-13. Medical electrical equipment – Part 2-13. Particular requirements for basic safety and essential performance of an anaesthetic workstation
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 139 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 12 | Foreword |
| 14 | Introduction |
| 18 | 201.1 Scope, object and related standards 201.1. 1 * Scope |
| 19 | 201.1. 2 Object 201.1. 3 Collateral standards 201.1. 4 *Particular standards |
| 20 | 201.2 Normative references |
| 23 | 201.3 Terms and definitions active anaesthetic gas scavenging system |
| 24 | anaesthetic gas anaesthetic gas delivery system piping |
| 25 | anaesthetic ventilator anaesthetic workstation breathing tube circle absorber assembly danger zone |
| 26 | disposal hose disposal system exhaust port exhaust valve fresh gas |
| 27 | fresh-gas inlet fresh-gas outlet high-flow transfer and receiving system transfer and receiving system that connects to a high-flow-rate disposal system low-flow transfer and receiving system transfer and receiving system that connects to a low-flow-rate disposal system |
| 28 | monitoring equipment patient connection port power device power supply protection device receiving system spillage transfer system |
| 29 | y-piece 201.4 General requirements 201.4. 3 * Essential performance 201.4. 10 Power supply 201.4. 10.101* Requirements for pneumatic power input |
| 30 | 201.5 General requirements for testing ME equipment 201.5.101 Additional general requirements for testing of anaesthetic workstations and anaesthetic workstation components including accessories 201.5.101.1 Test conditions |
| 31 | 201.5.101.2 Test equipment 201.5.101.3 * Gas flow rate and leakage specifications Correct all test measurements to STPD or BTPS, as appropriate. 201.6 Classification of ME equipment or ME systems 210.7 ME equipment identification, marking and documents 201.7.2 Marking on the outside of ME equipment or ME equipment parts 201.7.2.3 * Consult accompanying documents |
| 32 | 201.7.2.101 Marking with year of manufacture or use-by date Check compliance by visual inspection. 201.7.2.102 Operator-accessible gas-specific inlet and outlet 201.7.2.103 * Operator-accessible gas power supply outlet 201.7.2.104 Devices Components, parts and accessories containing phthalates |
| 33 | 201.7.2.105 Cylinder and pipeline pressure indicators 201.7.4.2 * Control devices 201.7.4.3 * Unit of measure 201.7.9.1 General |
| 34 | 201.7.9.2.1 General 201.7.9.2.2 * Warnings and safety notices 201.7.9.2.8 * Start-up procedure 201.7.9.2.101 Additional requirements for the instructions for use ((previously under 201.7.9.2.14)) |
| 35 | 201.7.9.3 Technical description 201.7.9.3.1 General 201.7.9.3.101 Components |
| 36 | 201.7.9.3.102 Anaesthetic workstations intended to be mounted to a wall or ceiling pendant 201.8 Protection against electrical hazards from ME equipment 201.8.11.3 Power supply cords 201.8.11.3.101 * Additional requirements for power supply cords |
| 37 | 201.9 Protection against mechanical hazards of ME equipment and ME systems 201.9.2 Mechanical hazards associated with moving parts 201.9.2.1 General 201.9.2.101 Maintenance points 201.9.2.102 * Lighting 201.9.2.103 * Integrated seating |
| 38 | 201.9.2.104 * Arrangement of control positions 201.9.4 Instability hazards 201.9.4.2.4.3 Movement over a threshold 201.10 Protection against unwanted and excessive radiation hazards |
| 39 | 201.11 Protection against excessive temperatures and other hazards 201.11.6.3 Spillage on ME equipment and ME systems Replacement: Check compliance by the following test: 201.11.6.8 Compatibility with substances used with the ME equipment 201.11.8 Interruption of the power supply/supply mains to ME equipment 201.11.8.101 * General requirements |
| 40 | 201.11.8.102 * Alarm condition for power supply failure 201.11.8.103 * Internal electrical power source |
| 41 | 201.11.101 Packaging systems for components intended to be sterilized 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12.4 Protection against hazardous output 201.12.4.101 * Accidental adjustment of operating controls |
| 42 | 201.12.4.102 * Additional requirements for anaesthetic workstations 201.12.4.103 Respiratory gas monitoring equipment 201.12.4.103.1 Carbon dioxide monitoring equipment |
| 43 | 201.12.4.103.2 Oxygen monitoring equipment 201.12.4.103.3 Anaesthetic agent monitoring equipment 201.12.4.104 Exhaled volume monitoring equipment 201.12.4.104.1 * Accuracy |
| 44 | 201.12.4.104.2 Alarm conditions 201.12.4.105 * Anaesthetic breathing system integrity alarm condition 201.12.4.106 * Anaesthetic breathing system continuing-positive-pressure alarm condition |
| 45 | 201.12.4.107 Anaesthetic gas delivery system oxygen supply and delivery 201.12.4.107.1 Oxygen supply failure alarm system 201.12.4.107.2 * Oxygen supply failure protection device |
| 46 | 201.12.4.107.3 * Hypoxic mixture delivery selection protection device 201.12.4.108 * Protection device for the workplace environment 201.12.4.109 Airway pressure monitoring equipment |
| 47 | 201.13 Hazardous situations and fault conditions 201.13.101 * Simultaneous failure 201.14 Programmable electrical medical systems (PEMS) 201.14.6.1 * Identification of known and foreseeable hazards |
| 48 | 201.14.101 Software life cycle processes 201.15 Construction of ME equipment 201.15.3.5 Rough handling test Amend as follows: 201.15.101 Operator-detachable, flow-direction-sensitive components parts and accessories 201.16 ME systems 201.16.9.2.1 Multiple socket-outlet Addition: Add the following list item: |
| 49 | 201.16.101 Additional requirements for signal input/output part 201.16.101.1 General 201.16.101.2 Connection to electronic health record 201.16.101.3 Connection to distributed alarm system 201.16.101.4 * Connection for remote control 201.17 Electromagnetic compatibility of ME equipment and ME systems |
| 50 | 201.101 Additional requirements for anaesthetic gas delivery systems 201.101.1 Identification and documents 201.101.1.1 Instructions for use |
| 51 | 201.101.1.2 Technical description 201.101.2 * Interruption of the electrical power supply 201.101.3 Protection against cross-contamination of volatile anaesthetic agents 201.101.4 Medical gas supply 201.101.4.1 Cylinder supplies 201.101.4.1.1 Inlet connector |
| 52 | 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 |
| 53 | 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 control element 201.101.5.2 Leakage after the flow rate adjustment control element |
| 54 | 201.101.6 Gas flow rate metering 201.101.6.1 Graduations and accuracy 201.101.6.2 Flow rate adjustment control |
| 55 | 201.101.6.3 * Carbon dioxide flow rate adjustment control 201.101.7 Gas mixers 201.101.8 * Oxygen flush |
| 56 | 201.101.9 * Fresh-gas outlet 201.102 Additional requirements for an anaesthetic breathing system 201.102.1 Identification, marking and documents 201.102.1.1 Marking 201.102.1.1.1 Non-metallic components parts 201.102.1.1.2 Bag/ventilator control 201.102.1.1.3 Absorbent bypass |
| 57 | 201.102.1.1.4 Inspiratory and expiratory ports of a circle absorber assembly 201.102.1.2 Instructions for use |
| 59 | 201.102.2 Pressure limitation protection device 201.102.2.1 * Maximum limited pressure protection device 201.102.2.2 * Adjustable pressure limitation protection device 201.102.3 Packaging of parts of anaesthetic breathing systems component packaging 201.102.4 * Electrical conductivity |
| 60 | 201.102.5 Connection ports 201.102.5.1 Patient connection port 201.102.5.2 Exhaust port connector 201.102.5.3 * Reservoir bag connection port |
| 62 | 201.102.5.4 Anaesthetic ventilator port connector 201.102.5.5 Anaesthetic breathing system component port connector 201.102.5.6 * Inspiratory and expiratory port connectors of a circle absorber assembly 201.102.5.7 Other port connectors |
| 63 | 201.102.6 * Leakage 201.102.7 * Inspiratory and expiratory pressure/flow rate characteristics 201.102.8 Anaesthetic breathing system components parts and accessories 201.102.8.1 * Y-piece 201.102.8.2 * Exhaust valve |
| 64 | 201.102.9 Circle absorber assemblies 201.102.9.1 * Constructional requirements 201.102.9.2 * Absorbent bypass mechanism |
| 65 | 201.102.9.3 Resistance to flow rate 201.102.10 Inspiratory and expiratory valves 201.102.10.1 * Constructional requirements 201.102.10.2 Opening pressure |
| 66 | 201.102.10.3 Pressure flow-rate characteristics 201.102.10.4 * Reverse flow rate and dislocation |
| 67 | 201.102.11 * Fresh-gas inlet 201.102.12 Ventilation modes 201.103 Additional requirements for an anaesthetic gas scavenging system 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 |
| 68 | 201.103.3 Basic requirements 201.103.3.1 Normal condition 201.103.3.1.1 Anaesthetic gas scavenging system inlet pressure 201.103.3.1.2 Induced flow rate 201.103.3.1.3 Flow resistance 201.103.3.1.4 Spillage to atmosphere |
| 69 | 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 receiving system 201.103.4 Connectors 201.103.4.1 Hose connectors |
| 70 | 201.103.4.2 Connections between parts of transfer systems and receiving systems 201.103.4.3 Connections to diverting respiratory gas monitors 201.103.5 Transfer system 201.103.5.1 Inlet |
| 71 | 201.103.5.2 Outlet 201.103.6 Receiving system 201.103.6.1 Inlet connectors 201.103.6.2 * Outlet connectors 201.103.6.3 Hoses 201.103.6.4 Particle filter |
| 72 | 201.103.7 Transfer systems and receiving systems with integral power device 201.103.8 Visual indicator 201.104 Additional requirements for an anaesthetic vapour delivery system 201.104.1 Identification, marking and documents 201.104.1.1 * Marking |
| 73 | 201.104.1.2 Instructions for use 201.104.2 Delivered vapour concentration 201.104.2.1 Controls |
| 74 | 201.104.2.2 * Accuracy |
| 75 | 201.104.3 * Vapour concentration during and after oxygen flush |
| 76 | 201.104.4 Connectors 201.104.5 Cross-contamination 201.104.6 Anaesthetic vapour delivery system filling |
| 77 | 201.104.7 Packaging of anaesthetic vapour delivery system parts and accessories 201.105 Additional requirements for an anaesthetic ventilator 201.105.1 Instructions for use |
| 78 | 201.105.2 Pressure limitation protection device 201.105.2.1 Maximum limited pressure protection device 201.105.2.2 * Adjustable pressure limitation protection device |
| 79 | 201.105.3 Activation of automatic ventilation 201.105.4 Breathing system connection port 201.105.5 Interruption of the electrical or pneumatic power supply 201.105.6 Exhaust port connector |
| 80 | 201.105.7 * Timed ventilatory pause 201.105.7.1 Expiratory pause |
| 81 | 201.105.7.2 Inspiratory pause The following applies to an inspiratory pause function. 201.105.8 * Subatmospheric pressure |
| 83 | Key |
| 84 | 201.106 Display of pressure-volume loops 201.107 Clinical evaluation 202 Electromagnetic disturbances — Requirements and tests 203 General requirements for radiation protection in diagnostic X-ray equipment 206 Usability |
| 85 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.5.2.2 * Technical description |
| 86 | 208.6.8.3 * Global indefinite alarm signal inactivation states 208.6.8.4 * Termination of inactivation of alarm signals 208.6.12 * Alarm system logging 209 Requirements for environmentally conscious design 210 Process requirements for the development of physiologic closed-loop controllers 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 87 | 212 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| 88 | Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems or their parts 201.C.1 Marking on the outside of ME equipment and ME systems or their parts |
| 90 | 201.C.3 Marking of controls and instruments |
| 91 | 201.C.4 Accompanying documents, general |
| 98 | 201.C.4 Accompanying documents, technical description |
| 99 | Annex D (informative) Symbols on marking |
| 102 | Annex AA (informative) Particular guidance and rationale |
| 118 | Pausing mechanical ventilation is necessary for certain clinical procedures. |
| 120 | Annex BB (normative) Test for flammability of anaesthetic agent BB.1 General BB.2 Spark ignition tests BB.3 Surface temperature ignition tests |
| 121 | Annex CC (informative) Data interface requirements For consideration during CD stage |
| 122 | Annex DD |
| 126 | Bibliography |
| 128 | Anhang ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered |
