🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS ISO 80601-2-80:2018

BS ISO 80601-2-80:2018

$215.11

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

Published By Publication Date Number of Pages
BSI 2018 98
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
2 undefined
13 201.1 Scope, object and related standards
201.1.1 * Scope
14 201.1.2 Object
201.1.3 Collateral standards
15 201.1.4 Particular standards
201.2 Normative references
17 201.3 Terms and definitions
19 201.4 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
20 201.4.11.101 * Additional requirements for pressurized gas input
201.4.11.101.1 Overpressure requirement
201.4.11.101.2 Compatibility requirement
21 201.5 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
22 201.6 Classification of me equipment and me systems
201.6.101 * Additional requirements for classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
29 201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
31 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
32 201.11.7 Biocompatiblity of me equipment and me systems
33 201.11.8 Interruption of the power supply/supply mains to me equipment
201.11.8.101 Additional requirements for interruption of the power supply/supply mains to me equipment alarm condition
201.11.8.101.1 Alarm conditions
34 201.11.8.101.2 Alternative power supply/supply mains
35 201.12 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
38 201.12.1.102 Pressure-controlled breath type
40 201.12.1.103 Other breath types
41 201.12.2.101 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
42 201.12.4.101.3 * High-pressure alarm condition and protection device
43 201.12.4.102 Measurement of expired volume
201.12.4.103 * Maximum limited pressure protection device
201.12.4.104 Hypoventilation alarm condition
201.12.4.105 * High leakage alarm condition
44 201.12.4.106 * CO2 rebreathing
201.12.101 * Protection against accidental adjustments
45 201.13 Hazardous situations and fault conditions for me equipment
46 201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15.101 Mode of operation
201.15.102 Pre-use check
201.16 Me systems
47 201.17 Electromagnetic compatibility of me equipment and me systems
201.101 Gas connections
201.101.1 Vbs connectors
201.101.1.1 * General
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
48 201.101.1.2.4 Accessory port
201.101.1.2.5 Monitoring probe port
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
49 201.102.2 Labelling
201.102.3 Breathing sets
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 * Spontaneous breathing during loss of power supply
50 201.104 * Training
201.105 * Indication of duration of operation
201.106 Functional connection
201.106.1 General
51 201.106.2 * 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
201.107.2 Flow-volume loops
52 201.108 Power supply cords
201.109 Ventilatory support equipment security
202 Electromagnetic disturbances — Requirements and tests
53 206 Usability
55 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
56 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Related products

BS ISO 80601-2-80:2018
$215.11