標準號：DIN EN 60601-2-19-2017
中文標準名稱：醫療電氣設備.第2-19部分:嬰兒保育箱的基本安全及基本性能用詳細要求(IEC 60601-2-19-2009+Cor.-2012+A1-2016);德文版本EN 60601-2-19-2009+A11-2011+A1-2016
英文標準名稱：Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009 + Cor.:2012 + A1:2016); German version EN 60601-2-19:2009 + A11:2011 + A1:2016
標準類型：C47
發布日期：1999/12/31 12:00:00
實施日期：2017/9/1 12:00:00
中國標準分類號：C47
國際標準分類號：11.040.10
引用標準：DIN EN 60601-1-2013;DIN EN 60601-1 Beiblatt 2-2009;DIN EN 60601-1-1-2002;DIN EN 60601-1-2-2016;DIN EN 60601-1-3-2014;DIN EN 60601-1-4-2001;DIN EN 60601-1-6-2016;DIN EN 60601-1-8-2014;DIN EN 60601-1-9-2014;DIN EN 60601-1-10-2016;DIN EN 60601-1-11-2016;DIN
適用范圍：This particular standard specifies safety requirements for infant incubators but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device.