Standard No.:	GB/T 19702-2021
English Name:	In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
Chinese Name:	体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	GB    National Standard
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Source Content Issued by:	SAMR; SAC
Issued on:	2021-03-09
Implemented on:	2022-4-1
Status:	valid
Superseding:	GB/T 19702-2005 In vitro
Target Language:	English
File Format:	PDF
Word Count:	10500 words
Translation Price(USD):	350.0
Delivery:	via email in 1~3 business day

本标准规定了体外诊断医疗器械和医学实验室使用的参考测量程序内容的要求。
本标准适用于提供差示值或比例量值的参考测量程序。附录A提供了有关名义特性和序量的信息。
本标准适用于在检验医学各个学科分支中，需要编写参考测量程序文件的所有个人、机构或研究所。