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
ISO/TR 18112-2006 发布历史
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由国际标准化组织 IX-ISO 发布于 2006-01。
ISO/TR 18112-2006 在中国标准分类中归属于: C39 医用电子仪器设备。
ISO/TR 18112-2006的历代版本如下：
- 2006年01月 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
- 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.