标准号:DIN EN ISO 18777-2009
中文标准名称:移动式医用液氧系统.特殊要求(ISO 18777:2005),DIN EN ISO 18777:2009-07的英文版本
英文标准名称:Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005); English version of DIN EN ISO 18777:2009-07
标准类型:C46
发布日期:1999/12/31 12:00:00
实施日期:2009/7/1 12:00:00
中国标准分类号:C46
国际标准分类号:11.040.10
引用标准:EN 980-2003;EN 1041-1998;EN 1251-1-2000;EN 1251-2-2000;EN 1251-3-2000;ISO 4135-2001;ISO 7000;ISO 15001-2003;ISO 18779;EN 13544-2-2002;IEC 60601-1-1988;IEC 60601-1 AMD 1-1991;IEC 60601-1 AMD 2-1995;IEC 60529-2001;IEC 60079-4-1975
适用范围:IEC 60601-1:1988, Clause 1, applies except as follows:Amendments (add at end of 1.1):1.1This International Standard specifies requirements for the safety and essential performance of transportableliquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consistof a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portableunit. These devices are mostly used in home care applications and in health care facilities/institutions. Thesedevices are often used without professional supervision.Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from thisInternational Standard.The requirements of this International Standard which replace or modify the requirements ofIEC 60601-1:1998 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 Intematinal Standard can have environmental impactduring the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmentalimpact are addressed in ISO 14971.