ISO 7197-2006 神经外科植入物.无菌、一次性使用的脑积水分流管和组件

sigh007

                   【英文标准名称】:     Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components            【原文标准名称】:     神经外科植入物.无菌、一次性使用的脑积水分流管和组件            【标准号】:     ISO 7197-2006            【标准状态】:     现行            【国别】:     国际            【发布日期】:     2006-06    【实施或试行日期】: 【发布单位】: 国际标准化组织(IX-ISO)【起草单位】: ISO/TC 150【标准类型】: ()【标准水平】: ()【中文主题词】: 定义;名称与符号;企业;一次性使用设备;软管;外科植入物;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【英文主题词】: Data of the manufacturer;Definitions;Designations;English language;Enterprises;Equipment for single use;Hoses;Implants (surgical);Instructions for use;Labelling (process);Marking;Medical devices;Medical equipment;Medical instruments;Medical sciences;Medical technology;Neurologyackages;Quality control;Specification (approval);Specifications;Sterile equipment;Surgery;Surgical implants;User information;Valves【摘要】: This International Standard specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.This International Standard gives no recommendation concerning the superiority of a certain type of valve.For manufacturing, it defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.The benefit of this International Standard for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.This International Standard does not apply to active implants for the treatment of hydrocephalus.【中国标准分类号】: C35【国际标准分类号】: 11_040_40【页数】: 6P;A4【正文语种】: 英语