Transportable Liquid Oxygen Systems for Medical Use - Particular Requirements (Adopted ISO 18777:2005, first edition, 2005-02-15, with Canadian deviations)
医用可运输液氧系统.特殊要求(采用ISO 18777-2005 第一版 2005-02-15 带加拿大偏差)
发布日期:
2008-02-01
CSA序言这是CAN/CSA-Z18777《医用可运输液氧系统-特殊要求》的第一版,采用了同名ISO(国际标准化组织)标准18777(第一版,2005-02-15)。1范围IEC 60601-1:1988,第1条,除以下情况外适用:修改件(在1.1末尾添加):1.1本国际标准规定了用作氧气治疗供应源的可运输液态氧系统的安全和基本性能要求。这些设备通常由患者在使用时携带的便携式装置和用于重新填充便携式装置的容器组成。
这些设备主要用于家庭护理应用和医疗设施/机构。这些设备通常在没有专业监督的情况下使用。本国际标准不包括用作氧气管道系统供应源的液氧容器。本国际标准的要求取代或修改了IEC 60601-1:1998及其修订件1(1991)和2(1995)的要求,旨在优先于相应的一般要求。1.4补充:注:符合本国际标准的产品规划和设计可能在产品生命周期内产生环境影响。附件BB阐述了环境方面的问题。
ISO 14971中阐述了环境影响的其他方面。
CSA PrefaceThis is the first edition of CAN/CSA-Z18777, Transportable liquid oxygen systems for medical use - Particular requirements, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 18777 (first edition, 2005-02-15).1 ScopeIEC 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 transportable liquid oxygen systems which are used as a supply source for oxygen therapy. These devices usually consist of a portable unit to be carried by or with the patient whilst in use and the vessel used to refill the portable unit. These devices are mostly used in home care applications and in health care facilities/institutions. These devices are often used without professional supervision.Liquid oxygen vessels used as a supply source for oxygen pipeline systems are excluded from this International Standard.The requirements of this International Standard which replace or modify the requirements of IEC 60601-1:1998 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.1.4Addition:NOTE Planning and design of products complying with this Internatinal Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.