TS EN ISO 18778 Respiratory Equipment - Neonatal Monitors - Specific Features

In the ISO 18778 standard developed by the International Standards Organization (ISO), the characteristics and test methods of neonatal respiratory monitors are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 18778 Respiratory equipment - Neonatal monitors - Certain features.

This standard describes requirements for the safety and basic performance of monitors used to detect life-threatening events in children under the age of three, sleeping or resting. This international standard applies to devices used in home care applications. These monitors are generally used without constant professional supervision.

The ISO 18778 standard also covers the accessories of these devices, including the probes and cables required to apply the monitor to the patient. However, it does not include monitors intended for use in healthcare facilities.

This standard specifies requirements for baby monitors used to recognize life-threatening situations in a sleeping baby.

This standard is linked to assurance standards and specialty standards. Assurance standards include requirements for specific technologies and hazards and apply to relevant equipment, such as medical systems, electromagnetic compatibility (EMC), and radiation protection in X-ray devices. Specialty standards apply to specific types of equipment, such as medical electron accelerators, high-frequency surgical equipment, and hospital beds.

The standards that are referred to as normative in the implementation of the ISO 18778 standard and indispensable for its implementation are: EN 71-1, EN 980, EN 1041, ISO 4135, IEC 60601-1, IEC 60601-1-2, IEC 60529, IEC 60068-2-32 , IEC 60068-2-64, IEC 60079-4: 1975, IEC 60601-2-23, IEC 60601-2-27, ISO 7000, ISO 9919 and ISO 15001.

Our organization also provides testing services for ISO 18778 neonatal breathing monitors within the scope of laboratory services.