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

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

标准号

ISO/TR 18112-2006

发布日期

2006年01月

实施日期

废止日期

无

中国标准分类号

C39

国际标准分类号

11.100.10

发布单位

IX-ISO

适用范围

This Technical Report 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.

ISO/TR 18112-2006 中可能用到的仪器设备