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

This Technical Report summarizes regulatory requirements and associated guidance for information suppliedby 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 asinstructions for use.Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and theUnited States are included.Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations fromAustralia are included for comparison.IVD medical devices for self-testing are excluded.

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