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BS ISO 80601-2-79:2018

BS ISO 80601-2-79:2018

$215.11

Medical electrical equipment – Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

Published By Publication Date Number of Pages
BSI 2018 88
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PDF Catalog

PDF Pages PDF Title
2 undefined
6 Foreword
8 Introduction
11 201.1 Scope, object and related standards
201.1.1 * Scope
12 201.1.2 Object
13 201.1.3 Collateral standards
201.1.4 Particular standards
14 201.2 Normative references
16 201.3 Terms and definitions
17 201.4 General requirements
201.4.3 Essential performance
18 201.4.3.101 * 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
201.4.11.101.2 Compatibility requirement
19 201.5 General requirements for testing of me equipment
201.5.101 * Additional requirements for the general requirements for testing of me equipment
201.5.101.1 Ventilatory support equipment test conditions
201.5.101.2 * Gas flowrate and leakage specifications
201.5.101.3 * Ventilatory support equipment testing errors
20 201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
26 201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
27 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
30 201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.1 Accuracy of controls and instruments
31 201.12.1.101 Volume-controlled breath type
34 201.12.1.102 Pressure-controlled breath type
36 201.12.1.103 Other breath types
37 201.12.2.101 Usability of me equipment
201.12.4 Protection against hazardous output
201.12.4.101 * Measurement of airway pressure
201.12.4.101.1 General
201.12.4.101.2 Low airway pressure alarm condition
38 201.12.4.102 Measurement of expired volume
201.12.4.103 * Maximum limited pressure protection device
201.12.4.104 Hypoventilation alarm condition
201.12.4.105 * CO2 rebreathing
39 201.12.101 Protection against accidental adjustments
40 201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15.101 Mode of operation
201.15.102 Pre-use check
41 201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 Gas connections
201.101.1 Vbs connectors
201.101.1.1 * General
42 201.101.1.2 Other named ports
201.101.1.2.1 General
201.101.1.2.2 Patient-connection port
201.101.1.2.3 * Manual ventilation port
201.101.1.2.4 Accessory port
201.101.1.2.5 Monitoring probe port
43 201.101.1.2.6 Oxygen inlet port
201.101.1.2.7 Flow-direction-sensitive components
201.102 Requirements for the vbs and accessories
201.102.1 * General
201.102.2 Labelling
201.102.3 Breathing sets
44 201.102.4 * Humidification
201.102.4.1 Humidifier
201.102.4.2 Heat and moisture exchanger (hme)
201.102.5 Breathing system filters (bsf)
201.103 * Training
201.104 * Indication of duration of operation
45 201.105 Functional connection
201.105.1 General
201.105.2 * Connection to an electronic health record
201.105.3 Connection for remote control
201.106 Display loops
201.106.1 Pressure-volume loops
201.106.2 Flow-volume loops
46 201.107 Spontaneous breathing during loss of ventilation
202 Electromagnetic disturbances — Requirements and tests
47 206 Usability
48 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
50 Annex C(informative)Guide to marking and labelling requirements for me equipment and me systems
56 Annex D(informative)Symbols on marking
58 Annex AA(informative)Particular guidance and rationale
71 Annex BB(informative)Data interface requirements
77 Annex CC(informative)Reference to the essential principles
81 Annex DD(informative)Terminology — Alphabetized index of defined terms
85 Bibliography

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BS ISO 80601-2-79:2018
$215.11