ISO 10310:1995 神经外科移植 可移植神经刺激品的标志和包装.

标准编号：ISO 10310:1995

中文名称：神经外科移植 可移植神经刺激品的标志和包装.

英文名称：Neurosurgical implants — Marking and packaging of implantable neural stimulators

发布日期：1995-03

标准范围

规定了用于刺激神经系统（大脑、脊髓、周围神经和邻近结构）的植入式神经刺激器的标记、标签、包装和附带文件的要求。还包括植入或外部辅助组件，包括用于激活或调整神经刺激器的外部控制和编程设备。未规定使用植入式神经刺激器的适应症或禁忌症，也未规定测试或正常操作变量参数的范围。

Specifies requirements for marking, labelling, packaging and accompanying documentation for implantable neural stimulators intended for stimulation of the nervous system (brain, spinal cord, peripheral nerves and adjacent structures). Also covers implanted or external ancillary components, including the external control and programming equipment used for the activation or adjustment of neural stimulators. Does not specify indications or contraindications for the use of implantable neural stimulators, nor testing or the range of normal operating variable parameters.

标准预览图