ISO 15198:2004

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer


ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.


General Information

Status Current
Edition 2004
No. of Pages 10
ICS Classification 11.100.10 In vitro diagnostic test systems
Committee ISO/TC 212
Available for Purchase For sale in Singapore only
Adoption ISO