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eLibrary >
BS EN ISO 80601-2-13:2022 - TC Tracked Changes. Medical electrical equipment - Particular requirements for basic safety and essential performance of an anaesthetic workstation >
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BS EN ISO 80601-2-13:2022 - TC Tracked Changes. Medical electrical equipment - Particular requirements for basic safety and essential performance of an anaesthetic workstation, 2022
- A-30383267.pdf [Go to Page]
- undefined
- European foreword
- Endorsement notice
- Foreword
- Introduction
- 201.1 Scope, object and related standards
- 201.1. 1 * Scope [Go to Page]
- 201.1.2 Object
- 201.1. 3 Collateral standards
- 201.1. 4 *Particular standards
- 201.2 Normative references
- 201.3 Terms and definitions
- 201.4 General requirements
- 201.4. 3 * Essential performance [Go to Page]
- 201.4.4 Additional requirements for expected service life
- 201.4. 10 Power supply
- 201.4.10.101* Requirements for pneumatic power input
- 201.5 General requirements for testing ME equipment [Go to Page]
- 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
- 201.5.101.3 * Gas flow rate and leakage specifications
- Correct all test measurements to STPD or BTPS, as appropriate. [Go to Page]
- 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 [Go to Page]
- 201.7.2 Marking on the outside of ME equipment or ME equipment parts
- 201.7.2.3 * Consult accompanying documents
- 201.7.2.101 Marking with year of manufacture or use-by date
- Check conformity by visual inspection. [Go to Page]
- 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
- 201.7.4.2 * Control devices
- 201.7.4.3 * Unit of measure
- 201.7.9.1 General
- 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
- 201.7.9.3 Technical description
- 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 [Go to Page]
- 201.8.11.3 Power supply cords
- 201.8.11.3.101 * Additional requirements for power supply cords
- 201.9 Protection against mechanical hazards of ME equipment and ME systems [Go to Page]
- 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
- 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 [Go to Page]
- 201.11.6.3 Spillage on ME equipment and ME systems
- Replacement:
- Check conformity by the following test: [Go to Page]
- 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
- 201.11.8.103 * Internal electrical power source
- 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 [Go to Page]
- 201.12.4.101 * Accidental adjustment of operating controls
- 201.12.4.102 * Additional requirements for anaesthetic workstations [Go to Page]
- 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 [Go to Page]
- 201.12.4.104 Exhaled volume monitoring equipment
- 201.12.4.104.1 * Accuracy
- 201.12.4.104.2 Alarm conditions [Go to Page]
- 201.12.4.105 * Anaesthetic breathing system integrity alarm condition
- 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
- 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
- 201.13 Hazardous situations and fault conditions
- 201.13.101 * Simultaneous failure
- 201.14 Programmable electrical medical systems (PEMS) [Go to Page]
- 201.14.6.1 * Identification of known and foreseeable hazards
- 201.14.101 Software life cycle processes
- 201.15 Construction of ME equipment [Go to Page]
- 201.15.3.5 Rough handling test [Go to Page]
- Amend as follows:
- 201.15.101 Operator-detachable, flow-direction-sensitive parts and accessories
- 201.16 ME systems [Go to Page]
- 201.16.9.2.1 Multiple socket-outlet
- Addition:
- Add the following list item: [Go to Page]
- 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
- 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 [Go to Page]
- 201.101.1 Identification and documents
- 201.101.1.1 Instructions for use
- 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
- 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
- 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
- 201.101.6 Gas flow rate metering
- 201.101.6.1 Graduations and accuracy
- 201.101.6.2 Flow rate adjustment control
- 201.101.6.3 * Carbon dioxide flow rate adjustment control
- 201.101.7 Gas mixers
- 201.101.8 * Oxygen flush
- 201.101.9 * Fresh-gas outlet [Go to Page]
- 201.101.10 Interface to interchangeable anaesthetic vapour delivery systems
- 201.102 Additional requirements for an anaesthetic breathing system [Go to Page]
- 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
- 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
- 201.102.2 Pressure limitation protection devices
- 201.102.2.1 * Maximum limited pressure protection device
- 201.102.2.2 * Adjustable pressure limit protection device
- 201.102.3 Packaging of parts of anaesthetic breathing systems
- 201.102.4 * Electrical conductivity
- 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 [Go to Page]
- 201.102.5.3.1 Arrangement and connector
- 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
- 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
- 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
- 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
- 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
- 201.102.10.4 * Reverse flow rate and dislocation
- 201.102.11 * Fresh-gas inlet
- 201.102.12 Ventilation modes
- 201.103 Additional requirements for an AGSS [Go to Page]
- 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
- 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 [Go to Page]
- 201.103.3.1.4 Spillage to atmosphere
- 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
- 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
- 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
- 201.104 Additional requirements for interchangeable and non-interchangeable anaesthetic vapour delivery systems [Go to Page]
- 201.104.1 Identification, marking and documents
- 201.104.1.1 * Marking
- 201.104.1.2 Instructions for use
- 201.104.2 Delivered vapour concentration
- 201.104.2.1 Controls
- 201.104.2.2 * Accuracy
- 201.104.3 * Vapour concentration during and after oxygen flush
- 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
- 201.105 Additional requirements for an anaesthetic ventilator [Go to Page]
- 201.105.1 Instructions for use
- 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
- 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
- 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. [Go to Page]
- 201.105.8 * Subatmospheric pressure
- Key
- 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
- 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
- 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
- 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 [Go to Page]
- 201.C.3 Marking of controls and instruments
- 201.C.4 Accompanying documents, general
- 201.C.4 Accompanying documents, technical description
- Annex D (informative) Symbols on marking
- Annex AA (informative) Particular guidance and rationale [Go to Page]
- Subclause 201.102.5.2 Exhaust port connector [Go to Page]
- Subclause 201.102.5.3.3 Connectors of the reservoir bag connecting tube
- Holding mechanical ventilation is necessary for certain clinical procedures.
- Annex BB (normative) Test for flammability of anaesthetic agent [Go to Page]
- BB.1 General
- BB.2 Spark ignition tests
- BB.3 Surface temperature ignition tests
- Annex CC (informative) Terminology — alphabetized index of defined terms
- Bibliography [Go to Page]
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