ISO 18778:2022
Respiratory equipment — Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
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
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$361.74 NZD
|
|
| HardCopy |
$406.09 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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
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
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
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
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
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
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
11.5 Interruption of the power supply / supply mains to ME equipment
11.5.1 General
11.5.2 Power sources
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
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
12.3.6 Apnoeic patient alarm condition
12.3.7 Sensor fault
12.3.8 Clinical performance evaluation
12.4 Usability of ME equipment
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
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
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
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
23.4 Additional requirements for alarm system logging
24 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Annex A (informative) General guidance and rationale
Annex B (informative) Sequence of testing
Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
Annex D (informative) Symbols on marking
Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current
Annex F (informative) Suitable measuring supply circuits
Annex G (informative) Protection against hazards of ignition of flammable anaesthetic mixtures
Annex H (informative) PEMS structure, PEMS development life-cycle and documentation
Annex I (informative) ME systems aspects
Annex J (informative) Survey of insulation paths
Annex K (informative) Simplified patient leakage current diagrams
Annex L (informative) Insulated winding wires for use without interleaved insulation
Annex M (informative) Reduction of pollution degrees
Annex N (informative) Data interface requirements
Annex O (informative) Considerations for a clinical performance study
Annex P (informative) Reference to the IMDRF essential principles and labelling guidances
Annex Q (informative) Reference to the essential principles
Annex R (informative) Reference to the general safety and performance requirements
Bibliography
Terminology — Alphabetized index of defined terms
Previous versions
Keep me up-to-date
Register to receive notifications when updates are made to this standard.
Related Information
Similar Standards
-
AS/NZS 3200.2.4:2006
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Cardiac defibrillators
-
AS/NZS 3200.2.41:2002
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Surgical luminaires and luminaires for diagnosis
-
AS/NZS 4966:2002
Ultrasonics - Pulsed Doppler diagnostic systems - Test procedures to determine performance
-
AS/NZS IEC 60601.2.20:2022 (RLV)
Medical electrical equipment, Part 2.20: Particular requirements for the basic safety and essential performance of infant transport incubators
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
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
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
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
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
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
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
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
11.5 Interruption of the power supply / supply mains to ME equipment
11.5.1 General
11.5.2 Power sources
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
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
12.3.6 Apnoeic patient alarm condition
12.3.7 Sensor fault
12.3.8 Clinical performance evaluation
12.4 Usability of ME equipment
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
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
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
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
23.4 Additional requirements for alarm system logging
24 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Annex A (informative) General guidance and rationale
Annex B (informative) Sequence of testing
Annex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
Annex D (informative) Symbols on marking
Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the patient leakage current and patient auxiliary current
Annex F (informative) Suitable measuring supply circuits
Annex G (informative) Protection against hazards of ignition of flammable anaesthetic mixtures
Annex H (informative) PEMS structure, PEMS development life-cycle and documentation
Annex I (informative) ME systems aspects
Annex J (informative) Survey of insulation paths
Annex K (informative) Simplified patient leakage current diagrams
Annex L (informative) Insulated winding wires for use without interleaved insulation
Annex M (informative) Reduction of pollution degrees
Annex N (informative) Data interface requirements
Annex O (informative) Considerations for a clinical performance study
Annex P (informative) Reference to the IMDRF essential principles and labelling guidances
Annex Q (informative) Reference to the essential principles
Annex R (informative) Reference to the general safety and performance requirements
Bibliography
Terminology — Alphabetized index of defined terms