YY/T 0684-2008 in English

本标准规定了用于刺激神经系统(脑、脊髓、末梢神经和邻近组织)的植入式神经刺激器的标识、标签、包装和随附文件的要求。
本标准还涵盖可植入的或外部接入的辅助部件,其中包括用于神经刺激器的启动或调整的外部控制器和编程器。
本标准没有规定应用植入式神经刺激器的适应症或禁忌症;也未规定测试或常规操作可变参数的范围。但是本标准要求这些相关的信息应包含在临床医生给患者进行治疗时使用的每个植入式脉冲发生器、植入式RF接收器或RF发射器的随附文件中。

Scope

This standard specifies the requirements for identification, labeling, packaging and accompanying documentation of implantable neurostimulators used to stimulate the nervous system (brain, spinal cord, peripheral nerves and adjacent tissues). This standard also covers implantable or externally accessible ancillary components, including external controllers and programmers for activation or adjustment of neurostimulators. This standard does not specify indications or contraindications for the use of implantable neurostimulators; nor does it specify ranges of variable parameters for testing or routine operation. However, this standard requires that this relevant information be included in the documentation accompanying each implanted pulse generator, implanted RF receiver, or RF transmitter used by clinicians to treat patients.