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BS EN ISO 80601-2-12:2020 Medical electrical equipment - Particular requirements for basic safety and essential performance of critical care ventilators, 2020
- undefined
- European foreword
- Endorsement notice
- 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. 7.2.3 * Consult accompanying documents
- 201. 7.2.4.101 Additional requirements for accessories
- 201. 7.2.13.101 Additional requirements for physiological effects
- 201. 7.2.17.101 Additional requirements for protective packaging
- 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. 7.9.1 Additional 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. 7.9.2.8.101 * 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. 7.9.2.16.101 * Additional requirements for reference to the technical description
- 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 * Volume-control inflation-type
- 201. 12.1.102 * Pressure-control inflation-type
- 201. 12.1.103 Other inflation-types
- 201. 12.1.104 * Inspiratory volume monitoring
- 201. 12.1.105 * 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 airway pressure
- 201. 12.4.103 * Measurement of expired volume and low volume alarm conditions
- 201. 12.4.103.1 Ventilators intended to provide a tidal volume >50 ml
- 201. 12.4.103.2 Ventilators intended to provide a tidal volume ≤50 ml
- 201. 12.4.104 * Expiratory end-tidal CO2 monitoring equipment
- 201. 12.4.105 * Maximum limited pressure protection device
- 201. 12.4.106 * High airway pressure alarm condition and protection device
- 201. 12.4.107 PEEP alarm conditions
- 201. 12.4.108 * Obstruction alarm condition
- 201. 12.4.109 * Disconnection alarm condition
- 201. 12.4.110 Protection against inadvertent setting of high airway pressure
- 201. 12.101 * Protection against accidental or unintentional adjustments
- 201. 13 Hazardous situations and fault conditions for ME equipment [Go to Page]
- 201. 13.2.101 * Additional specific single fault conditions
- 201. 13.2.102 * Failure of one gas supply to a ventilator
- 201. 13.2.103 * Independence of ventilation control function and related risk control measures
- 201. 13.2.104 * Failure of 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. 16.2.101 * Additional general requirements for accompanying documents of an ME system
- 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 input port
- 201. 101.2.1 Connector
- 201. 101.2.2 * Filter
- 201. 101.3 VBS 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. 101.3.2.7 Temperature sensor port
- 201. 102 Requirements for the VBS and accessories [Go to Page]
- 201. 102.1 * General
- 201. 102.2 Labelling
- 201. 102.3 Breathing tubes
- 201. 102.4 * Water vapour management [Go to Page]
- 201. 102.4.1 Humidification system
- 201. 102.4.2 Heat and moisture exchanger (HME)
- 201. 102.6 Breathing system filters
- 201. 102.7 Ventilator breathing systems [Go to Page]
- 201. 102.7.1 * Leakage from complete VBS
- 201. 102.7.2 * Non-invasive ventilation
- 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 ventilatory pause [Go to Page]
- 201. 107.1 Expiratory pause
- 201. 107.2 Inspiratory pause
- 202 Electromagnetic disturbances — Requirements and tests [Go to Page]
- 202.4.3.1 * Compliance criteria
- 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]
- 208.6.3.2.2.2.101 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 interfaces [Go to Page]
- BB.1 Background and purpose
- BB.2 Data definition
- Annex CC (informative) Reference to the essential principles
- Annex DD (informative) Reference to the general safety and performance requirements
- Annex EE (informative) Terminology — Alphabetized index of defined terms
- Bibliography [Go to Page]