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现行 CAN/CSA Z305.8-03(R2023)
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Medical Supply Units 医疗供应单位
发布日期: 2003-01-14
1.范围1。1本标准规定了医疗区域(如普通病房)以及特殊用途区域(如手术室、诱导室、康复病房、透析室、重症监护或治疗室以及其他中间护理区域)的医疗供应装置的安全要求。医疗供应装置旨在单独或与其他服务(例如电力、液体供应或设备连接)一起供应医疗气体。1.2本标准还规定了影响安全的机组可靠运行的相关要求。1.3本标准不包括CSA C22中已涵盖的电气安全一般要求。2号601.1和CAN/CSAZ32;b) 其他设备,如护士呼叫系统或监控设备,可并入或安装在医疗供应单元中; c) 本标准涵盖的设备预期生理功能导致的安全危害;和d)医用气体控制面板。注:医用气体控制面板的一个例子是氮气控制面板,用于在高压下供应氮气,以驱动手术工具。1.4在本标准中,“应”用于表示要求,即用户为遵守本标准而有义务满足的规定;“应该”用于表示建议或建议但不需要的建议;“可”用于表示一个选项或在标准范围内允许的选项。注释随附条款不包括要求或替代要求;随附条款的注释的目的是将解释性或信息性材料与文本分开。表和图的注释被视为表或图的一部分,可以作为要求编写。 方程式和图表的图例被视为要求。
1 Scope1.1This Standard specifies the safety requirements for medical supply units for application in medical areas, such as general wards, as well as in special purpose areas, such as operating theatres, induction rooms, recovery wards, dialysis units, intensive care or therapy units, and other intermediate care areas. Medical supply units are intended to supply medical gases, either singly or in combination with other services, for example, electric power, liquid supply, or equipment connections.1.2This Standard also specifies requirements pertaining to reliable operation of the units where it impinges on safety.1.3This Standard does not covera) the general requirements for electrical safety already covered in CSA C22.2 No. 601.1 and CAN/CSAZ32;b) other equipment, such as devices for nurse call systems or monitoring, that can be incorporated in, or mounted on, medical supply units;c) safety hazards resulting from the intended physiological function of equipment covered by this Standard; andd) medical gas control panels.Note: An example of a medical gas control panel is a nitrogen control panel used to supply nitrogen at high pressure to drive surgical tools.1.4In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Legends to equations and figures are considered requirements.
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