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BS EN ISO 18778:2022

$198.66

Respiratory equipment. Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors

Published By Publication Date Number of Pages
BSI 2022 68
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This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: —    intended for use in the home healthcare environment; —    intended for use by a lay operator; —    intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and —    intended for transit-operable use. NOTE       An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor. EXAMPLE        probes, cables distributed alarm system

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PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
8 Foreword
10 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
16 4 General requirements
4.1 General
4.2 Essential performance
4.3 ME equipment or ME system parts that contact the patient
4.4 Single fault condition for ME equipment
5 General requirements for testing of ME equipment
5.1 General
5.2 Infant cardiorespiratory monitor testing errors
17 6 Classification of ME equipment and ME systems
6.1 General
6.2 Additional requirements for classification of ME equipment and ME systems
7 ME equipment identification, marking and documents
7.1 General
7.2 Information to be supplied by the manufacturer
7.3 Additional requirements for accessories
18 7.4 Additional requirements for marking on the outside of ME equipment or ME equipment parts
7.5 General instructions for use
7.6 Additional requirements for warnings and safety notices
19 7.7 Additional requirements for start-up procedure
7.8 Additional requirements for operating instructions
7.8.1 General
7.8.2 Lay operator operating instructions
20 7.8.3 Healthcare professional operator operating instructions
7.9 Cleaning, disinfection, and sterilization
7.10 Additional requirements for maintenance
7.11 Additional requirements for accessories, supplementary equipment, used material
7.12 Additional requirements for the technical description
21 8 Protection against electrical hazards from ME equipment
9 Protection against mechanical hazards of ME equipment and ME systems
9.1 General
9.2 Additional requirements for instability from unwanted lateral movement
9.3 Grips and other handling devices
10 Protection against unwanted and excessive radiation hazards
11 Protection against excessive temperatures and other hazards
11.1 General
22 11.2 Cleaning and disinfection of ME equipment or ME system
11.3 Sterilization of ME equipment or ME system
11.4 Biocompatibility of ME equipment and ME systems
23 11.5 Interruption of the power supply / supply mains to ME equipment
11.5.1 General
11.5.2 Power sources
24 11.5.3 Alternative power supply/supply mains
12 Accuracy of controls and instruments and protection against hazardous outputs
12.1 General
12.2 Accuracy of controls and instruments
25 12.3 Accuracy of controls and instruments
12.3.1 General
12.3.2 Cardiorespiratory monitoring
12.3.3 Direct monitoring – respiration
12.3.4 Indirect monitoring – heart rate
12.3.5 Indirect monitoring from pulse oximetry
26 12.3.6 Apnoeic patient alarm condition
27 12.3.7 Sensor fault
12.3.8 Clinical performance evaluation
12.4 Usability of ME equipment
28 13 Hazardous situations and fault conditions for ME equipment
14 Programmable electrical medical systems (PEMS)
15 Construction of ME equipment
15.1 General
15.2 Mode of operation
15.3 Pre-use check
29 16 ME systems
17 Electromagnetic compatibility of ME equipment and ME systems
18 Requirements for the accessories
18.1 General
18.2 Labelling
19 Training
20 Functional connection
20.1 General
20.2 Connection to an electronic health record
20.3 Connection to a distributed alarm system
30 21 Electromagnetic disturbances – Requirements and tests
21.1 General
21.2 Compliance criteria
21.3 Requirements applicable to all ME equipment and ME systems
21.4 Additional general requirements
22 Usability
22.1 General
31 22.2 Primary operating functions
23 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
23.1 General
23.2 Volume and characteristics of auditory alarm signals and information signals
23.3 Additional requirements for termination of alarm signal inactivation
32 23.4 Additional requirements for alarm system logging
24 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
33 Annex A (informative) General guidance and rationale
38 Annex B (informative) Sequence of testing
39 Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
42 Annex D (informative) Symbols on marking
43 Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current
44 Annex F (informative) Suitable measuring supply circuits
45 Annex G (informative) Protection against hazards of ignition of flammable anaesthetic mixtures
46 Annex H (informative) PEMS structure, PEMS development life-cycle and documentation
47 Annex I (informative) ME systems aspects
48 Annex J (informative) Survey of insulation paths
49 Annex K (informative) Simplified patient leakage current diagrams
50 Annex L (informative) Insulated winding wires for use without interleaved insulation
51 Annex M (informative) Reduction of pollution degrees
52 Annex N (informative) Data interface requirements
55 Annex O (informative) Considerations for a clinical performance study
57 Annex P (informative) Reference to the IMDRF essential principles and labelling guidances
59 Annex Q (informative) Reference to the essential principles
61 Annex R (informative) Reference to the general safety and performance requirements
64 Bibliography
65 Terminology — Alphabetized index of defined terms
BS EN ISO 18778:2022
$198.66