BS EN ISO 80601-2-13:2022 – TC
$280.87
Tracked Changes. Medical electrical equipment – Particular requirements for basic safety and essential performance of an anaesthetic workstation
| Published By | Publication Date | Number of Pages |
| BSI | 2022 | 304 |
This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system (AGSS); anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device. NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1. An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard. NOTE 2 The applicability of this document is indicated in Table AA.2. This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components including accessories, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 188 | undefined |
| 191 | European foreword Endorsement notice |
| 195 | Foreword |
| 197 | Introduction |
| 199 | 201.1 Scope, object and related standards 201.1. 1 * Scope |
| 200 | 201.1.2 Object 201.1. 3 Collateral standards 201.1. 4 *Particular standards |
| 201 | 201.2 Normative references |
| 202 | 201.3 Terms and definitions |
| 208 | 201.4 General requirements 201.4. 3 * Essential performance 201.4.4 Additional requirements for expected service life 201.4. 10 Power supply 201.4.10.101* Requirements for pneumatic power input |
| 209 | 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 Additional general requirements for testing of anaesthetic workstations and anaesthetic workstation components including accessories 201.5.101.1 Test conditions 201.5.101.2 Test equipment |
| 210 | 201.5.101.3 * Gas flow rate and leakage specifications Correct all test measurements to STPD or BTPS, as appropriate. 201.5.101.4 Test consideration regarding oxygen Conformity checks and tests as specified in this document shall be performed using the type(s) of oxygen the anaesthetic workstation has been designed for and as specified by the manufacturer in the instructions for use (see 201.7.9.2.101 ii), i.e. 201.6 Classification of ME equipment or ME systems 201.7 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 |
| 211 | 201.7.2.101 Marking with year of manufacture or use-by date Check conformity 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 Components, parts and accessories containing phthalates 201.7.2.105 Cylinder and pipeline pressure indicators 201.7.2.106 Magnetic resonance environment |
| 212 | 201.7.4.2 * Control devices 201.7.4.3 * Unit of measure 201.7.9.1 General |
| 213 | 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 |
| 214 | 201.7.9.3 Technical description |
| 215 | 201.7.9.3.1 General 201.7.9.3.101 Components 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 |
| 216 | 201.9 Protection against mechanical hazards of ME equipment and ME systems 201.9.2 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 |
| 217 | 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 201.11 Protection against excessive temperatures and other hazards 201.11.6.3 Spillage on ME equipment and ME systems Replacement: |
| 218 | Check conformity 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 201.11.8.102 * Alarm condition for power supply failure |
| 219 | 201.11.8.103 * Internal electrical power source |
| 220 | 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 201.12.4.102 * Additional requirements for anaesthetic workstations |
| 222 | 201.12.4.103 Respiratory gas monitoring equipment 201.12.4.103.1 Carbon dioxide monitoring equipment 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 |
| 223 | 201.12.4.104.2 Alarm conditions 201.12.4.105 * Anaesthetic breathing system integrity alarm condition |
| 224 | 201.12.4.106 * Anaesthetic breathing system continuing-positive-pressure alarm condition 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 |
| 225 | 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 |
| 226 | 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 |
| 227 | 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 parts and accessories 201.16 ME systems 201.16.9.2.1 Multiple socket-outlet Addition: |
| 228 | Add the following list item: 201.16.101 Additional requirements for signal input/output part 201.16.101.1 General 201.16.101.2 Connection to other equipment for network/data coupling |
| 229 | 201.16.101.3 Connection to distributed alarm system/information system 201.16.101.4 * Connection for remote control 201.17 Electromagnetic compatibility of ME equipment and ME systems 201.101 Additional requirements for anaesthetic gas delivery systems 201.101.1 Identification and documents 201.101.1.1 Instructions for use |
| 230 | 201.101.1.2 Technical description |
| 231 | 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 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 |
| 232 | 201.101.4.2.2 Inlet filtration 201.101.4.2.3 Reverse flow and cross-flow protection device 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 |
| 233 | 201.101.5.2 Leakage after the flow rate adjustment control element 201.101.6 Gas flow rate metering 201.101.6.1 Graduations and accuracy 201.101.6.2 Flow rate adjustment control |
| 234 | 201.101.6.3 * Carbon dioxide flow rate adjustment control 201.101.7 Gas mixers 201.101.8 * Oxygen flush |
| 235 | 201.101.9 * Fresh-gas outlet 201.101.10 Interface to interchangeable anaesthetic vapour delivery systems 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 parts 201.102.1.1.2 Bag/ventilator control |
| 236 | 201.102.1.1.3 Absorbent bypass 201.102.1.1.4 Inspiratory and expiratory ports of a circle absorber assembly 201.102.1.2 Instructions for use |
| 237 | 201.102.2 Pressure limitation protection devices 201.102.2.1 * Maximum limited pressure protection device |
| 238 | 201.102.2.2 * Adjustable pressure limit protection device 201.102.3 Packaging of parts of anaesthetic breathing systems 201.102.4 * Electrical conductivity |
| 239 | 201.102.5 Ports and connectors 201.102.5.1 Patient connection port 201.102.5.2 *Exhaust port connector 201.102.5.3 * Reservoir bag connector 201.102.5.3.1 Arrangement and connector |
| 240 | 201.102.5.3.2 Marking 201.102.5.3.3 Connectors of the reservoir bag connecting tube 201.102.5.4 Anaesthetic ventilator port connector |
| 241 | 201.102.5.5 Anaesthetic breathing system port connector 201.102.5.6 * Inspiratory and expiratory port connectors of a circle absorber assembly 201.102.5.7 Other port connectors Check conformity by inspection and inspection of the risk management file. 201.102.6 * Leakage 201.102.7 * Inspiratory and expiratory pressure/flow rate characteristics |
| 242 | 201.102.8 Anaesthetic breathing system parts and accessories 201.102.8.1 * Y-piece 201.102.8.2 * Exhaust valve 201.102.8.3 * Breathing tubes |
| 243 | 201.102.9 Circle absorber assemblies 201.102.9.1 * Constructional requirements |
| 244 | 201.102.9.2 * Absorbent bypass mechanism 201.102.9.3 Resistance to flow rate 201.102.10 Inspiratory and expiratory valves 201.102.10.1 * Constructional requirements |
| 245 | 201.102.10.2 Opening pressure 201.102.10.3 Pressure flow-rate characteristics 201.102.10.4 * Reverse flow rate and dislocation |
| 246 | 201.102.11 * Fresh-gas inlet 201.102.12 Ventilation modes 201.103 Additional requirements for an AGSS 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 |
| 247 | 201.103.3 General requirements 201.103.3.1 Normal condition 201.103.3.1.1 AGSS inlet pressure 201.103.3.1.2 Induced flow rate for active AGSS 201.103.3.1.3 Flow resistance for active AGSS 201.103.3.1.4 Spillage to atmosphere |
| 248 | 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 for active AGSS 201.103.3.2.3 Subatmospheric pressure at the input of the receiving system for active AGSS 201.103.4 Connectors 201.103.4.1 Hose connectors |
| 249 | 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 201.103.5.2 Outlet |
| 250 | 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 for active AGSS 201.103.7 Transfer systems and receiving systems with integral power device for active AGSS 201.103.7 Transfer systems and receiving systems with integral power device for active AGSS 201.103.8 Visual indicator for active AGSS |
| 251 | 201.104 Additional requirements for interchangeable and non-interchangeable anaesthetic vapour delivery systems 201.104.1 Identification, marking and documents 201.104.1.1 * Marking 201.104.1.2 Instructions for use |
| 252 | 201.104.2 Delivered vapour concentration 201.104.2.1 Controls 201.104.2.2 * Accuracy |
| 254 | 201.104.3 * Vapour concentration during and after oxygen flush |
| 255 | 201.104.4 Connectors 201.104.5 Cross-contamination 201.104.6 Anaesthetic vapour delivery system filling 201.104.7 Packaging of anaesthetic vapour delivery system parts and accessories |
| 256 | 201.105 Additional requirements for an anaesthetic ventilator 201.105.1 Instructions for use |
| 257 | 201.105.2 Pressure limitation protection device 201.105.2.1 Maximum limited pressure protection device 201.105.2.2 * Adjustable pressure limit protection device |
| 258 | 201.105.3 Activation of automatic ventilation 201.105.4 Anaesthetic breathing system port connector 201.105.5 Interruption of the electrical or pneumatic power supply 201.105.6 Exhaust port connector |
| 259 | 201.105.7 * Timed ventilatory hold 201.105.7.1 Expiratory hold 201.105.7.2 Inspiratory hold The following applies to an inspiratory hold function. |
| 260 | 201.105.8 * Subatmospheric pressure |
| 261 | Key |
| 262 | 201.106 Display of pressure-volume loops 201.107 Clinical evaluation |
| 263 | 202 Electromagnetic disturbances — Requirements and tests 203 General requirements for radiation protection in diagnostic X-ray equipment 206 Usability |
| 264 | 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.5.2.2 * Technical description 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 |
| 265 | 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 212 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
| 266 | 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 |
| 268 | 201.C.3 Marking of controls and instruments 201.C.4 Accompanying documents, general |
| 274 | 201.C.4 Accompanying documents, technical description |
| 276 | Annex D (informative) Symbols on marking |
| 278 | Annex AA (informative) Particular guidance and rationale |
| 290 | Subclause 201.102.5.2 Exhaust port connector Subclause 201.102.5.3.3 Connectors of the reservoir bag connecting tube |
| 293 | Holding mechanical ventilation is necessary for certain clinical procedures. |
| 295 | Annex BB (normative) Test for flammability of anaesthetic agent BB.1 General BB.2 Spark ignition tests BB.3 Surface temperature ignition tests |
| 296 | Annex CC (informative) Terminology — alphabetized index of defined terms |
| 300 | Bibliography |
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