Standard No.:	GB/T 19703-2005
English Name:	In vitro
Chinese Name:	体外诊断医疗器械 物源性样本中量的测量 参考物质的说明
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
Issued by:	发布单位：
Issued on:	2005-3-23
Implemented on:	2005-12-1
Status:	superseded
Superseded by:	GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
Superseded on:	2021-12-1
Abolished on:	2021-12-01
Language:	English
File Format:	PDF
Word Count:	8000 words
Price(USD):	240.00
Delivery:	via email in 1~3 business day

本标准规定了参考物质说明的要求和格式。本标准适用于较高计量学水平的参考物质，这些参考物质可以被分类为一级测量标准和二级测量标准，其作用是作为参考测量程序的校准品或控制物质。本标准不适用于作为体外诊断测量系统组成部分的参考物质。本标准同时也提供了为确定数值而收集基础数据的规程，以及出具所赋值的方式。本标准还规定了证书格式。本标准不适用于这些参考物质的生产过程。