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eLibrary > BS EN ISO 80601-2-87:2021 Medical electrical equipment - Particular requirements for basic safety and essential performance of high-frequency ventilators >

BS EN ISO 80601-2-87:2021 Medical electrical equipment - Particular requirements for basic safety and essential performance of high-frequency ventilators, 2021

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BS EN ISO 80601-2-87:2021 Medical electrical equipment - Particular requirements for basic safety and essential performance of high-frequency ventilators, 2021

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European foreword
Endorsement notice [Go to Page]
Introduction
201. 1 Scope, object and related standards [Go to Page]
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 [Go to Page]
201. 4.3 Essential performance
201. 4.3.101 * Additional requirements for essential performance
201. 4.4 Additional requirements for expected service life
201. 4.6 * ME equipment or ME system parts that contact the patient
201. 4.11.101 * Additional requirements for pressurized gas input
201. 4.11.101.1 Overpressure requirement
201. 4.11.101.2 Compatibility requirement
201. 5 General requirements for testing of ME equipment [Go to Page]
201. 5.101 Additional requirements for general requirements for testing of ME equipment
201. 5.101.1 Ventilator test conditions
201. 5.101.2 * Gas flowrate and leakage specifications
201. 5.101.3 * Ventilator testing errors
201. 6 Classification of ME equipment and ME systems
201. 7 ME equipment identification, marking and documents [Go to Page]
201. 7.1.101 Information to be supplied by the manufacturer
201. 7.2.3 * Consult accompanying documents
201. 7.2.4.101 Additional requirements for accessories
201. 7.2.18 External gas source
201. 7.2.101 Additional requirements for marking on the outside of ME equipment or ME equipment parts
201. 7.4.3 * Units of measurement
201. 7.9.2.1.101 Additional general requirements
201. 7.9.2.2.101 * Additional requirements for warnings and safety notices
201. 7.9.2.8.101 * Additional requirements for start-up procedure
201. 7.9.2.9.101 * Additional requirements for operating instructions
201. 7.9.2.12 Cleaning, disinfection and sterilization
201. 7.9.2.14.101 * Additional requirements for accessories, supplementary equipment, used material
201. 7.9.3.1.101 * Additional general requirements
201. 7.9.3.101 Additional requirements for the technical description
201. 8 Protection against electrical hazards from ME equipment
201. 9 Protection against mechanical hazards of ME equipment and ME systems [Go to Page]
201. 9.6.2.1.101 * Additional requirements for audible acoustic energy
201. 9.101 * Additional requirements for suction procedures
201. 10 Protection against unwanted and excessive radiation hazards
201. 11 Protection against excessive temperatures and other hazards [Go to Page]
201. 11.1.2.2 * Applied parts not intended to supply heat to a patient
201. 11.6.5.101 * Additional requirements for ingress of water or particulate matter into ME equipment or ME system
201. 11.6.6 * Cleaning and disinfection of ME equipment or ME system
201. 11.6.7 Sterilization of ME equipment or ME system
201. 11.7 Biocompatibility of ME equipment and ME systems
201. 11.8.101 * Additional requirements for interruption of the power supply/supply mains to ME equipment
201. 12 Accuracy of controls and instruments and protection against hazardous outputs [Go to Page]
201. 12.1 * Accuracy of controls and instruments
201. 12.1.101 * Mean airway pressure
201. 12.1.102 Mean airway pressure limiting means for an HFV without a patient-connection port
201. 12.1.103 FiO2 concentration
201. 12.1.104 * Response of the ventilator to an increase in set O2 concentration
201. 12.4 Protection against hazardous output
201. 12.4.101 Oxygen monitor
201. 12.4.102 * Measurement of mean airway pressure and low and high mean airway pressure alarm conditions
201. 12.4.103 Measurement of mean airway pressure at the distal outlet of the jet system and high mean airway pressure alarm condition
201. 12.4.104 Measurement of pressure amplitude and low and high pressure amplitude alarm conditions
201. 12.4.105 Measurement of HFV volume and low and high HFV volume alarm condition
201. 12.4.106 * Maximum limited pressure protection device
201. 12.4.107 * High-pressure protection device
201. 12.4.108 Obstruction alarm condition
201. 12.4.109 * Disconnection alarm condition
201. 12.4.110 Minimum limited pressure protection device
201. 12.101 * Protection against accidental or unintentional adjustments
201. 13 Hazardous situations and fault conditions for ME equipment [Go to Page]
201. 13.101 * Additional specific single fault conditions
201. 13.102 * Failure of one gas supply to a ventilator
201. 13.103 * Independence of ventilation control function and related risk control measures
201. 13.104 * Failure of a functional connection to a ventilator control or monitoring means
201. 14 Programmable electrical medical systems (PEMS) [Go to Page]
201. 14.101 Software life cycle
201. 15 Construction of ME equipment [Go to Page]
201. 15.3.5.101 Additional requirements for rough handling
201. 15.3.5.101.1 * Shock and vibration (robustness)
201. 15.3.5.101.2 * Shock and vibration for a transit-operable ventilator during operation
201. 15.4.1 Construction of connectors
201. 15.101 Mode of operation
201. 15.102 Delivered oxygen concentration
201. 15.103 Accessory self-check
201. 16 ME systems [Go to Page]
201. 16.1.101 Additional general requirements for ME systems
201. 17 Electromagnetic compatibility of ME equipment and ME systems
201. 101 Gas connections [Go to Page]
201. 101.1 * Protection against reverse gas leakage
201. 101.2 Connection to a high-pressure inlet
201. 101.2.1 Connector
201. 101.2.2 * Filter
201. 101.3 HFV breathing system connectors [Go to Page]
201. 101.3.1 * General
201. 101.3.2 Other named ports
201. 101.3.2.1 Patient-connection port
201. 101.3.2.2 Gas output port and gas return port
201. 101.3.2.3 Emergency intake port
201. 101.3.2.4 Flow-direction-sensitive components
201. 101.3.2.5 * Accessory port
201. 101.3.2.6 Gas exhaust port
201. 102 Requirements for the HFV breathing system and accessories [Go to Page]
201. 102.1 * General
201. 102.2 Labelling
201. 102.3 Breathing tubes
201. 102.4 * Water vapour management
201. 102.5 Breathing system filters
201. 102.6 * Leakage from the complete VBS
201. 103 * Spontaneous breathing during loss of power supply
201. 104 * Indication of duration of operation
201. 105 Functional connection [Go to Page]
201. 105.1 General
201. 105.2 * Connection to an electronic health record
201. 105.3 * Connection to a distributed alarm system
201. 105.4 Connection for remote control
201. 106 Display loops [Go to Page]
201. 106.1 Pressure-volume loops
201. 106.2 Flow-volume loops
201. 107 Timed high-frequency oscillation pause
202 Electromagnetic disturbances – Requirements and tests [Go to Page]
202.4.3.1 * Configurations
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems
202.8.1.101 * Additional general requirements
206 Usability [Go to Page]
206.101 Primary operating functions
206.102 * Training
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Go to Page]
208.6.3.2.2.101 Additional requirements for 1 m (operator’s position) visual alarm signals and information signals
208.6.8.3.101 Additional requirements for global indefinite alarm signal inactivation states
208.6.8.4.101 * Additional requirements for termination of alarm signal inactivation
208.6.12.101 * Additional requirements for alarm system logging
Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems [Go to Page]
201.C.101 Marking on the outside of ME equipment, ME systems or their parts
201.C.102 Accompanying documents, general
201.C.103 Accompanying documents, instructions for use
201.C.104 Accompanying documents, technical description
Annex D (informative) Symbols on marking
Annex AA (informative) Particular guidance and rationale [Go to Page]
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses
Annex BB (informative) Data interface requirements [Go to Page]
BB.1 Background and purpose
BB.2 Data definition
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances
Annex DD (informative) Reference to the essential principles
Annex EE (informative) Reference to the general safety and performance requirements
Annex FF (informative) Terminology — alphabetized index of defined terms [Go to Page]

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