ISO/TR 18112:2006 实验室试验和体外诊断试验系统 专业人员用体外诊断试验医疗器械 厂商提供信息调整要求概要

标准编号：ISO/TR 18112:2006

中文名称：实验室试验和体外诊断试验系统 专业人员用体外诊断试验医疗器械 厂商提供信息调整要求概要

英文名称：Clinical laboratory testing and in vitro diagnostic test systems — In vitro diagnostic medical devices for professional use — Summary of regulatory requirements for information supplied by the manufac

发布日期：2006-01

标准范围

ISO/TR 18112:2006总结了针对专业用途IVD医疗设备制造商提供的信息的监管要求和相关指南。制造商提供的信息包括外部和直接容器上的标签以及使用说明。包括加拿大、欧盟、日本和美国的现行标签法规和监管指南。包括全球协调工作组的标签指南和澳大利亚提出的标签法规，以供比较。不包括用于自检的IVD医疗设备。

ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use.Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use.Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison.IVD medical devices for self-testing are excluded.

标准预览图