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作废 EN ISO 80601-2-13:2012
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Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011) 医疗电气设备 - 第2-13部分:麻醉工作站基本安全和基本性能的特殊要求(ISO 80601-2-13:2011)
发布日期: 2012-12-12
实施日期: 2012-12-12
ISO/IEC 80601-2-13:2011适用于专业操作人员不断参加的麻醉工作站进行吸入麻醉的基本安全性和基本性能。 ISO/IEC 80601-2-13:2011规定了完整麻醉工作站和以下麻醉工作站部件的特殊要求,尽管它们本身也被认为是单独的装置,但可以与其他相关的麻醉工作站部件结合使用形成一个给定规格的麻醉工作站: 麻醉气体输送系统; 麻醉呼吸系统; 麻醉气体清除系统; 麻醉蒸气输送系统; 麻醉呼吸机; 监控设备; 警报系统; 保护装置。 ISO/IEC 80601-2-13:2011也适用于其制造商打算连接到麻醉工作站的那些附件,其中这些附件的特性可能会影响麻醉工作站的基本安全性和基本性能。 如果一个条款或子条款专门用于仅适用于麻醉工作站部件,则该条款或条款的标题和内容将这样说。如果不是这样,则该条款或子条款
ISO/IEC 80601-2-13:2011 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. ISO/IEC 80601-2-13:2011 specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: anaesthetic gas delivery system; anaesthetic breathing system; anaesthetic gas scavenging system; anaesthetic vapour delivery system; anaesthetic ventilator; monitoring equipment; alarm system; protection device. ISO/IEC 80601-2-13:2011 is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to an anaesthetic workstation and its individual components, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components within the scope of ISO/IEC 80601-2-13:2011 are not covered by specific requirements in ISO/IEC 80601-2-13:2011 except in 7.2.13 and 8.4.1 of IEC 60601-1:2005. ISO/IEC 80601-2-13:2011 is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.
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归口单位: CEN/TC 215-
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