ISO 80601-2-55:2011
Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient.
ISO 80601-2-55:2011 specifies requirements for:
- anaesthetic gas monitoring,
- carbon dioxide monitoring, and
- oxygen monitoring.
ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents.
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1 Scope
201.1 Scope, object and related standards
201.1. 1 * Scope
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
201.4. 3.101 * Additional requirements for essential performance
201.4. 3.102 Additional requirements for acceptance criteria
201.4. 6 * Me equipment or me system parts that contact the patient
201.4.10.2.101 * Additional requirements for supply mains for me equipment and me systems
201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
201.7. 2.3 * Consult accompanying documents
201.7. 2.101 * Additional requirements for marking on the outside of me equipment or me equipment parts
201.7. 2.4.101 Additional requirements for accessories
201.7. 2.13.101 * Additional requirements for physiological effects (safety signs and warning statements)
201.7. 2.17.101 Additional requirements for protective packaging
201.7. 4.3 Unit of measure
201.7. 9.1 General requirements
201.7. 9.2.1.101 * Additional general requirements
201.7. 9.2.2.101 * Additional requirements for warnings and safety notices
201.7. 9.2.5.101 Additional requirements for me equipment description
201.7. 9.2.8.101 * Additional requirements for start-up procedure
201.7. 9.2.9.101* Additional requirements for operating instructions
201.7. 9.2.13.101 * Additional requirements for maintenance
201.7. 9.2.14.101 * Additional requirements for accessories, supplementary equipment, used material
201.7. 9.2.15.101* Additional requirements for environmental protection
201.7. 9.3.101 * Additional requirements for technical description
201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11. 6.4 Leakage
201.11. 6.5 * Ingress of water or particulate matter into me equipment or me systems
201.11. 6.6 * Cleaning and disinfection of me equipment or me systems
201.11. 6.7 Sterilization of me equipment or me systems
201.11. 6.8 Compatibility with substances used with me equipment
201.11. 8.101 Additional requirements for interruption of the power supply/supply mains to me equipment
201.11. 8.101.1 * Supply failure technical alarm condition
201.11. 8.101.2 * Settings and data storage following short interruptions or automatic switchover
201.11. 8.101.3 * Operation following long interruptions
201.11. 8.101.4 * Reserve electrical power source
201.11. 8.101.5 * Reserve electrical power source for transport outside a healthcare facility
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1 Accuracy of controls and instruments
201.12. 1.101 * Measurement accuracy
201.12. 1.101.1 General
201.12. 1.101.2 * Drift of measurement accuracy
201.12. 1.101.3 * Measurement accuracy of gas readings for gas mixtures
201.12. 1.102 * Total system response time and rise time
201.12. 1.103 * Indication of units of measure for gas readings
201.12. 1.104 * Indication of operating mode
201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15. 3.5.101 * Additional requirements for rough handling
201.15. 3.5.101.1 * Shock and vibration
201.15. 3.5.101.2 * Shock and vibration for professional transportation
201.15. 101 * Mode of operation
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 * Interfering gas and vapour effects
201.102 * Gas leakage
201.103 * Port connector for diverting rgm
201.104 * Minimum sampling flowrate
201.105 * Contamination of breathing systems
201.105. 1 Sampling tube
201.105. 2 Exhaust tube
202 Electromagnetic compatibility — Requirements and tests
202.6.2.1.7 * Patient simulation
202.6.2.1.10 Compliance criteria
202.6.2.3.1 * Requirements
206 Usability
206.6.2.2.2 Primary operating functions
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.1.2 * Alarm condition priority
208.6.5.1 * General requirements
208.6.6.2.101 * Additional requirements for adjustable alarm limit
208.6.8.5.101 * Additional requirements for alarm signal deactivation states, indication and access
209 Requirements for environmentally conscious design
210 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
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1 Scope
201.1 Scope, object and related standards
201.1. 1 * Scope
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
201.4. 3.101 * Additional requirements for essential performance
201.4. 3.102 Additional requirements for acceptance criteria
201.4. 6 * Me equipment or me system parts that contact the patient
201.4.10.2.101 * Additional requirements for supply mains for me equipment and me systems
201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
201.7. 2.3 * Consult accompanying documents
201.7. 2.101 * Additional requirements for marking on the outside of me equipment or me equipment parts
201.7. 2.4.101 Additional requirements for accessories
201.7. 2.13.101 * Additional requirements for physiological effects (safety signs and warning statements)
201.7. 2.17.101 Additional requirements for protective packaging
201.7. 4.3 Unit of measure
201.7. 9.1 General requirements
201.7. 9.2.1.101 * Additional general requirements
201.7. 9.2.2.101 * Additional requirements for warnings and safety notices
201.7. 9.2.5.101 Additional requirements for me equipment description
201.7. 9.2.8.101 * Additional requirements for start-up procedure
201.7. 9.2.9.101* Additional requirements for operating instructions
201.7. 9.2.13.101 * Additional requirements for maintenance
201.7. 9.2.14.101 * Additional requirements for accessories, supplementary equipment, used material
201.7. 9.2.15.101* Additional requirements for environmental protection
201.7. 9.3.101 * Additional requirements for technical description
201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11. 6.4 Leakage
201.11. 6.5 * Ingress of water or particulate matter into me equipment or me systems
201.11. 6.6 * Cleaning and disinfection of me equipment or me systems
201.11. 6.7 Sterilization of me equipment or me systems
201.11. 6.8 Compatibility with substances used with me equipment
201.11. 8.101 Additional requirements for interruption of the power supply/supply mains to me equipment
201.11. 8.101.1 * Supply failure technical alarm condition
201.11. 8.101.2 * Settings and data storage following short interruptions or automatic switchover
201.11. 8.101.3 * Operation following long interruptions
201.11. 8.101.4 * Reserve electrical power source
201.11. 8.101.5 * Reserve electrical power source for transport outside a healthcare facility
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1 Accuracy of controls and instruments
201.12. 1.101 * Measurement accuracy
201.12. 1.101.1 General
201.12. 1.101.2 * Drift of measurement accuracy
201.12. 1.101.3 * Measurement accuracy of gas readings for gas mixtures
201.12. 1.102 * Total system response time and rise time
201.12. 1.103 * Indication of units of measure for gas readings
201.12. 1.104 * Indication of operating mode
201.13 Hazardous situations and fault conditions
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15. 3.5.101 * Additional requirements for rough handling
201.15. 3.5.101.1 * Shock and vibration
201.15. 3.5.101.2 * Shock and vibration for professional transportation
201.15. 101 * Mode of operation
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 * Interfering gas and vapour effects
201.102 * Gas leakage
201.103 * Port connector for diverting rgm
201.104 * Minimum sampling flowrate
201.105 * Contamination of breathing systems
201.105. 1 Sampling tube
201.105. 2 Exhaust tube
202 Electromagnetic compatibility — Requirements and tests
202.6.2.1.7 * Patient simulation
202.6.2.1.10 Compliance criteria
202.6.2.3.1 * Requirements
206 Usability
206.6.2.2.2 Primary operating functions
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.1.2 * Alarm condition priority
208.6.5.1 * General requirements
208.6.6.2.101 * Additional requirements for adjustable alarm limit
208.6.8.5.101 * Additional requirements for alarm signal deactivation states, indication and access
209 Requirements for environmentally conscious design
210 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