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EN ISO 18778:2009 Standard

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  Keywords:

#standard #international #used #care #apply

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 18778:2005"

Anyway is still possible use the "EN ISO 18778:2005" until March 21st, 2010

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