DIN EN ISO 18778-2009 呼吸设备.婴儿监视器.特殊要求(ISO 18778-2005);德文版本EN ISO 18778-2009

标准号：DIN EN ISO 18778-2009
中文标准名称：呼吸设备.婴儿监视器.特殊要求(ISO 18778-2005);德文版本EN ISO 18778-2009
英文标准名称：Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005); English version of DIN EN ISO 18778:2009-08
标准类型：C46
发布日期：1999/12/31 12:00:00
实施日期：2009/8/1 12:00:00
中国标准分类号：C46
国际标准分类号：11.040.10;97.190
引用标准：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
适用范围： 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.