关键词:
制造日期
定义
名称与符号
企业
一次性使用设备
软管
外科植入物
使用说明书
加标签
作标记
医疗设备
医疗器械
医学科学
医疗技术学
神经病学
包装件
质量控制
规范(验收)
规范
无菌设备
外科学
用户信息
阀门
标准号:
BS EN ISO 7197-2006
摘要:
This International Standard specifies safety and performance requirements for sterile, single-use non-activehydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes *** International Standard gives no recommendation concerning the superiority of a certain type of *** manufacturing, it defines the mechanical and technical requirements. This International Standard definesthe technical information of the valve, to be given by the manufacturer. In respect to the different principles ofthe valve types, specific characteristics are defined for each group as declared by the *** benefit of this International Standard for the surgeon and the patient is to understand the informationgiven by the manufacturer and to obtain standardized information about the performance of a well workingproduct with new design characteristics. The benefit for the manufacturer is to define the importantrequirements for shunts as a basis for investigations during development as well as for quality control *** International Standard does not apply to active implants for the treatment of hydrocephalus.