ISO 18778:2005 PDF

IEC 60601-1:1988, Clause 1, applies except as follows:

Amendments (add at end of 1.1):

This International 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 International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision.

This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient.

This International Standard does not apply to monitors intended for use in health care facilities/institutions.

The requirements of this International 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.

1) Referred to as "monitor" throughout the document.