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高频手术设备及其附件检测项目报价? 解决方案? 检测周期? 样品要求? |
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本标准规定了妇科射频治疗仪的定义、分类、要求、试验方法、检验规则、标志、包装、运输及贮存等。本标准适用于3.1所定义的妇科射频治疗仪(以下简称治疗仪),该仪器用于妇科相关疾病的手术治疗。
本专用标准适用于2.2.101定义的多参数患者监护设备的安全要求。本标准的范围限于有一个以上的应用部分或多于一个单项功能,且连接到单一患者的设备。本标准未对单独的监护功能做规定。
本标准规定了肝脏射频消融治疗设备的定义、组成、要求、试验方法、检验规则、标志、包装、运输及贮存。本标准适用于3.1所定义的肝脏射频消融治疗设备(以下简称设备),该设备用于肝脏实体肿瘤的消融治疗。
本标准规定了射频消融导管的术语和定义、要求、试验方法。本标准适用于作为高频手术设备的手术附件,能够通过血管、腔道,把射频能量传递到目标组织,对目标组织实施切割、消融的导管,以下简称导管。
本标准规定了抓取钳的范围、术语和定义、要求、试验方法。本标准适用于内窥镜手术所使用的抓取钳。
本标准规定了咬切钳的范围、术语和定义、要求、试验方法。本标准适用于内窥镜手术所使用的咬切钳。
本标准规定了分离钳的范围、术语和定义、要求、试验方法。本标准适用于内窥镜手术所使用的分离钳。
本标准规定了内窥镜器械刮匙的范围、术语和定义、要求、试验方法。本标准适用于内窥镜手术使用的刮匙。
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 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 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 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.