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.pdf

标准号：ISO/TR 18112-2006
实施状态：作废
中文名称：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
发布日期：2006-01
起草单位：ISO/TC 212
标准简介：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.
文件格式：PDF
文件大小：1.08MB
文件页数：128
（以上信息更新时间为：2019-11-22）



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