ISO/TR 18112-2006 临床实验室试验和在实验室条件下诊断试验系统.在实验室条件下诊断用的专用医学设备.制造商提供信息的管理要求概要

标准号：ISO/TR 18112-2006
中文标准名称：临床实验室试验和在实验室条件下诊断试验系统.在实验室条件下诊断用的专用医学设备.制造商提供信息的管理要求概要
英文标准名称：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 manufacturer
标准类型：C39
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C39
国际标准分类号：11.100.10
适用范围：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.