GSO ISO 18778:2017

ISO 18778:2005
Gulf Standard   Current Edition · Approved on 03 October 2017

Respiratory equipment -- Infant monitors -- Particular requirements

GSO ISO 18778:2017 Files

English 26 Pages
Current Edition Reference Language

GSO ISO 18778:2017 Scope

IEC 60601-1:1988, Clause 1, applies except as follows: Amendments (add at end of 1.1): 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. 1.4 Addition: NOTE Planning and design of products complying with this Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.

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