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BS EN ISO 80601-2-12:2011:2013 Edition

BS EN ISO 80601-2-12:2011:2013 Edition

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Medical electrical equipment – Particular requirements for basic safety and essential performance of critical care ventilators

Published By Publication Date Number of Pages
BSI 2013 94
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PDF Catalog

PDF Pages PDF Title
14 201.1 Scope, object and related standards
201.1. 1 Scope
15 201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards
16 201.2 Normative references
19 201.3 Terms and definitions
22 201.4 General requirements
201.4. 3 Essential performance
201.4. 3.101 * Additional requirements for essential performance
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
23 201.4. 11.101.2 Compatibility requirement
201.5 General requirements for testing of me equipment
201.5. 101 * Additional requirements for general requirements for testing of me equipment
201.5. 101.1 Ventilator test conditions
24 201.5. 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
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
25 201.7. 2.4.101 Additional requirements for accessories
201.7. 2.13.101 Additional requirements for physiological effects
26 201.7. 2.17.101 Additional requirements for protective packaging
201.7. 4.3 * Unit of measure
201.7. 9.1 Additional general requirements
27 201.7. 9.2.1.101 Additional general requirements
201.7. 9.2.2.101 * Additional requirements for warnings and safety notices
28 201.7. 9.2.8.101 * Additional requirements for start-up procedure
201.7. 9.2.9.101 * Additional requirements for operating instructions
29 201.7. 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
30 201.7. 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
201.9. 6.2.1.101 Additional requirements for audible acoustic energy
31 201.9. 101 * Additional requirements for suction procedures
33 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11. 6.4 Leakage
34 201.11. 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
35 201.11. 8.101 Additional requirements for interruption of the power supply/supply mains to me equipment
201.11. 8.101.1 Technical alarm condition for power supply failure
201.11. 8.101.2 Internal electrical power source or external reserve electrical power source
36 201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1 * Accuracy of controls and instruments
201.12. 1.101 Volume-controlled breath type
39 201.12. 1.102 Pressure-controlled breath type
42 201.12. 1.103 * Delivered volume monitoring
201.12. 1.104 * Response of the ventilator to an increase in O2 concentration
44 201.12. 4 Protection against hazardous output
201.12. 4.101 Oxygen monitor
201.12. 4.102 * Measurement of airway pressure
45 201.12. 4.103 * Measurement of expired volume and low-volume alarm conditions
201.12. 4.103.1 Ventilators intended to provide a delivered volume > 50 ml
201.12. 4.103.2 Ventilators intended to provide a delivered volume u 50 ml
46 201.12. 4.104 * Maximum limited pressure protection device
201.12. 4.105 High-pressure alarm condition and protection device
201.12. 4.106 Peep alarm conditions
201.12. 4.107 * Obstruction alarm condition
47 201.12. 4.108 * Partial-occlusion alarm condition
201.12. 101 * Protection against accidental adjustments
201.13 Hazardous situations and fault conditions
201.13. 2.101 * Additional specific single fault conditions
48 201.13. 102 * Failure of one gas supply to a ventilator
201.13. 103 * Independence of ventilation control function and related risk control measures
201.14 Programmable electrical medical systems (pems)
201.14. 101 Software life cycle
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
49 201.15. 3.5.101.2 * Shock and vibration for a mobile ventilator
50 201.15. 101 Mode of operation
51 201.15. 102 Delivered oxygen concentration
201.15. 103 Accessory self-check
201.16 Me systems
201.16. 1.101 Additional general requirements for me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.17. 101 Additional requirements for electromagnetic compatibility of me equipment and me systems
201.101 Gas connections
201.101. 1 * Protection against reverse gas leakage
52 201.101. 2 Connection to the medical gas pipeline system
201.101. 3 Vbs connectors
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 Manual ventilation port
53 201.101. 3.2.4 Emergency intake port
201.101. 3.2.5 Flow-direction-sensitive components
201.101. 3.2.6 Accessory port
201.101. 3.2.7 Monitoring probe port
201.101. 3.2.8 Gas exhaust port
201.102 Requirements for the vbs and accessories
201.102. 1 * General
201.102. 2 Labelling
54 201.102. 3 Breathing tubes
201.102. 4 * Water management
201.102. 4.1 Humidification system
201.102. 4.2 Heat and moisture exchanger (hme)
201.102. 5 Gas mixers
201.102. 6 Breathing system filters
201.102. 7 Ventilator breathing systems
201.102. 7.1 Leakage from complete vbs
55 201.102. 7.2 * Non-invasive ventilation
201.103 * Spontaneous breathing during loss of power supply
56 201.104 * Training
201.105 * Indication of duration of operation
201.106 Signal input/output part
201.106. 1 General
201.106. 2 * Connection to an electronic health record
201.106. 3 * Connection to a distributed alarm system
201.106. 4 * Connection for remote control
201.107 Display loops
201.107. 1 Pressure-volume loops
57 201.107. 2 Flow-volume loops
201.108 * Timed ventilatory pause
201.108. 1 Expiratory pause
201.108. 2 Inspiratory pause
58 202  Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
202.6.2.1.10 * Compliance criteria
59 206  Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
60 208  Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.3.3.2.101 * Additional requirements for characteristics of alarm condition logging
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

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