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现行 CAN/CSA C22.2 NO.601.2.5-92(R1997)
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Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Ultrasonic Therapy Equipment (Adopted IEC 601- 2-5:1984) 医用电气设备.第2部分:超声治疗设备安全的特殊要求(采用IEC 601-2-5-1984)
发布日期: 2000-06-09
1范围本专用标准规定了第2.1.101款中定义的超声波治疗设备(以下简称设备)的安全要求,该设备的安装和使用应符合加拿大电气规范的规定,第一部分:本特殊标准不适用于由超声波驱动工具的设备(例如外科或牙科用设备),或使用聚焦超声脉冲波破坏肾结石或膀胱结石(碎石机)等砾岩的设备。本特定标准的要求是CSA标准CAN/CSA-C22的补充要求。2第601.1号,医用电气设备第1部分:安全通用要求,以下简称通用标准。为了测试和批准本特定标准范围内的设备,设备必须满足本特定标准和通用标准的组合要求(如适用)。 在本特定标准中,“应”表示强制性要求;“宜”表示建议,或建议但非强制性的建议。本标准包含加拿大偏差和编辑变更。
1ScopeThis Particular Standard specifies requirements for the safety of ULTRASONIC THERAPY EQUIPMENT as defined in Sub-clause 2.1.101, hereinafter referred to as EQUIPMENT and designed to be installed and used in accordance with the Rules of the Canadian Electrical Code, Part I.This Particular Standard does not apply to EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry) or in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotrites).The requirements of this Particular Standard are in addition to those of CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electrical Equipment Part 1: General Requirements for Safety, hereinafter referred to as the General Standard. For the purposes of testing and approving EQUIPMENT covered within the scope of this Particular Standard, the EQUIPMENT must meet the combined requirements, as applicable, of both this Particular Standard and the General Standard.In this Particular Standard, ""shall"" indicates a mandatory requirement; ""should"" indicates a recommendation, or that which is advised but not mandatory.Canadian Deviations and Editorial Changes are included in this Standard.
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