ISO 18778:2022 PDF

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

Open preview (PDF)

Title (English):

ISO 18778:2022

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

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 57
Publication date:: June 30, 2022
Edition:: ISO IS 18778 edition 2 version 1
ICS:: 11.040.10

Delivery type:

Full version25 €Read online 24h10 €Read online 72h15 €

Document language:

enru

Delivery time:Immediate download

Price:25 €

Description (English):

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

Technical details

Technical committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
SKU: ISO 18778:2022

Abstract

Overview

ISO 18778:2022 specifies the basic safety and essential performance requirements for infant cardiorespiratory monitors - medical electrical (ME) equipment intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age. The standard covers devices designed for home healthcare, lay operators, and transit‑operable use, and also applies to manufacturer‑intended accessories (for example probes, cables, and distributed alarm systems) when those accessories can affect safety or performance.

Key topics and technical requirements

ISO 18778:2022 addresses a full product lifecycle of infant cardiorespiratory monitors with focus areas including:

Scope and classification of ME equipment and ME systems for infant monitoring.
Essential performance and single‑fault safety considerations to ensure reliable operation under fault conditions.
Accuracy requirements for direct respiration monitoring and indirect heart‑rate monitoring (including pulse oximetry inputs) and requirements for apnoeic patient alarm conditions and sensor fault detection.
Testing and validation protocols, including clinical performance evaluation and a sequence of tests.
Identification, marking and documentation: labelling, operating instructions for lay operators and healthcare professionals, warnings, start‑up procedures, and maintenance guidance.
Protection against hazards: electrical, mechanical, thermal and radiation hazards; patient leakage current measurement guidance; biocompatibility; and precautions for cleaning, disinfection and sterilization.
Alarm systems: design, volume/characteristics, logging and inactivation behavior appropriate for infant monitoring.
Usability and training: human factors for lay operators and professional users to reduce use errors.
Electromagnetic compatibility (EMC) and electromagnetic disturbance testing.
Programmable electrical medical systems (PEMS) lifecycle and documentation requirements.
Functional connections: requirements for integration with electronic health records and distributed alarm systems.

Practical applications - who uses this standard

ISO 18778:2022 is used by:

Manufacturers and designers of infant cardiorespiratory monitors and accessory components to shape product specifications, risk management and design verification.
Test laboratories and certification bodies to develop compliance test protocols and assess essential performance and safety.
Regulators and procurement teams evaluating device safety, labeling and intended use in home healthcare.
Clinicians, home healthcare providers and caregivers for understanding device capabilities, alarms and safe operation guidance.

Related standards

ISO 18778:2022 complements other international standards for medical electrical equipment and home healthcare devices (standards addressing safety, EMC, usability and device lifecycle documentation) and should be used alongside applicable regional regulatory requirements when certifying infant monitoring devices.

Related standards

Other ISO standards

Abstract

Overview

Key topics and technical requirements

ISO 18778:2022 addresses a full product lifecycle of infant cardiorespiratory monitors with focus areas including:

Scope and classification of ME equipment and ME systems for infant monitoring.
Essential performance and single‑fault safety considerations to ensure reliable operation under fault conditions.
Accuracy requirements for direct respiration monitoring and indirect heart‑rate monitoring (including pulse oximetry inputs) and requirements for apnoeic patient alarm conditions and sensor fault detection.
Testing and validation protocols, including clinical performance evaluation and a sequence of tests.
Identification, marking and documentation: labelling, operating instructions for lay operators and healthcare professionals, warnings, start‑up procedures, and maintenance guidance.
Protection against hazards: electrical, mechanical, thermal and radiation hazards; patient leakage current measurement guidance; biocompatibility; and precautions for cleaning, disinfection and sterilization.
Alarm systems: design, volume/characteristics, logging and inactivation behavior appropriate for infant monitoring.
Usability and training: human factors for lay operators and professional users to reduce use errors.
Electromagnetic compatibility (EMC) and electromagnetic disturbance testing.
Programmable electrical medical systems (PEMS) lifecycle and documentation requirements.
Functional connections: requirements for integration with electronic health records and distributed alarm systems.

Practical applications - who uses this standard

ISO 18778:2022 is used by:

Manufacturers and designers of infant cardiorespiratory monitors and accessory components to shape product specifications, risk management and design verification.
Test laboratories and certification bodies to develop compliance test protocols and assess essential performance and safety.
Regulators and procurement teams evaluating device safety, labeling and intended use in home healthcare.
Clinicians, home healthcare providers and caregivers for understanding device capabilities, alarms and safe operation guidance.

ISO 18778:2022 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards

Related standards

Systems and software engineering — Software life cycle processes

Asset management — Vocabulary, overview and principles

Asset management — Asset management system — Requirements

Information technology — Radio frequency identification device conformance test methods — Part 2: Test method…

Information technology — Multimedia framework (MPEG-21) — Part 22: User Description

Milk — Determination of the lactoperoxidase activity — Photometric method (Reference method)

Carbonaceous materials for the production of aluminium — Cold and tepid ramming pastes — Expansion/shrinkage…

Agricultural machinery — Safety — Part 13: Large rotary mowers