標準號：DIN EN ISO 18778-2009
中文標準名稱：呼吸設備.嬰兒監視器.特殊要求(ISO 18778-2005);德文版本EN ISO 18778-2009
英文標準名稱：Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005); English version of DIN EN ISO 18778:2009-08
標準類型：C46
發布日期：1999/12/31 12:00:00
實施日期：2009/8/1 12:00:00
中國標準分類號：C46
國際標準分類號：11.040.10;97.190
引用標準：EN 71-1-1998/A1-2001;EN 71-1-1998;EN 980-2003;EN 1041-2003;ISO 4135-2001;IEC 60601-1-1998;IEC 60601-1 AMD 1-1991;IEC 60601-1 AMD 2-1995;IEC 60601-1 AMD 2 Corrigendum 1-1995;IEC 60601-1-2-2001;IEC 60529-2001;IEC 60068-2-32-1975;IEC 60601-2-23-1999;IEC 6060
適用范圍： 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 ofIEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over thecorresponding general requirements.1.4Addition:NOTE Planning and design of products complying with this Standard can have environmental impact during theproduct life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact areaddressed in ISO 14971.