SS-EN-ISO-18778 › Historical Revision Information
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)
Medical devices
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Designation Name
SS-EN ISO 18778:2009
Revision Level
2009 EDITION
Status
Superseded
Publication Date
April 27, 2009
Language(s)
English
Page Count
44
International Equivalent
EN ISO 18778:2009(IDT); ISO 18778:2005(IDT)