- Author:
Jun WANG
1
;
Hong ZHANG
1
;
Leiying DAI
1
;
Huiru WANG
1
;
Min LU
1
Author Information
- Publication Type:Journal Article
- Keywords: ISO; in vitro diagnosis; standardization system; standards
- From: Chinese Journal of Medical Instrumentation 2018;42(5):361-364
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVEThe quality of diagnostic products is closely related to people's health. The standards and standardization system are essential to IVD industry and supervision.
METHODSThrough a study of the standards of ISO, EU, the USA and China, a comparative analysis was carried out.
RESULTSChina's IVD standardization system is different from other organization in terms of standard quantity, type and content. The standardization system has its own characteristics, and conforms to the current industrial characteristics and regulatory needs.
CONCLUSIONSSome suggestions are put forward to provide references for strengthening supervision of IVD products.