This Malaysian Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This Malaysian Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision.
This Malaysian Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient.
This Malaysian Standard does not apply to monitors intended for use in health care facilities/institutions. The requirements of this Malaysian Standard, which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over the corresponding general requirements.
Published
• (none) / (none) / (none)
PDF
26/04/2019
40
NSC 18 - Medical Devices and Facilities for Healthcare
