ISO 16061:2008 与无源外科植入物联合使用的仪器 一般要求

标准编号：ISO 16061:2008

中文名称：与无源外科植入物联合使用的仪器 一般要求

英文名称：Instrumentation for use in association with non-active surgical implants — General requirements

发布日期：2008-12

标准范围

ISO 16061:2008规定了与非活性外科植入物相关的仪器的一般要求。这些要求适用于仪表的制造和翻新后的再供应。ISO 16061:2008也适用于可能连接到动力驱动系统的仪器，但不适用于动力驱动系统本身。关于安全性，ISO 16061:2008给出了制造商提供的预期性能、设计属性、材料选择、设计评估、制造、灭菌、包装和信息的要求。

ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

标准预览图