標(biāo)準(zhǔn)號(hào)：BS EN ISO 10651-6-2009
中文標(biāo)準(zhǔn)名稱：醫(yī)用肺通氣器.基本安全性和必要性能的詳細(xì)要求.家庭護(hù)理通氣配套設(shè)備
英文標(biāo)準(zhǔn)名稱：Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Home-care ventilatory support devices
標(biāo)準(zhǔn)類型：C46
發(fā)布日期：2009/6/30 12:00:00
實(shí)施日期：2009/6/30 12:00:00
中國標(biāo)準(zhǔn)分類號(hào)：C46
國際標(biāo)準(zhǔn)分類號(hào)：11.040.10
引用標(biāo)準(zhǔn)：ISO 32;ISO 4135;ISO 5356-1;ISO 5356-2;ISO 5359;ISO 5362;ISO 5367;ISO 7396-1;ISO 14937;ISO 15001;ISO 15223-2000;IEC 60079-4;IEC 60601-1-1988;IEC 60601-1 AMD 1-1991;IEC 60601-1-2-2001;IEC 60601-1-6;IEC 60601-1-8-2003
適用范圍：IEC 60601-1:1988, Clause 1 applies, except as follows.Amendment:This part of ISO 10651 specifies the basic safety and essential performance requirements for home-careventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in healthcare facilities) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required.The requirements of this part of ISO 10651 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.