Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer (ISO 15198:2004, IDT)
This Malaysian Standard 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. This standard applies to all in vitro diagnostic medical devices.
Published
• (none) / (none) / (none)
PDF
17/01/2021
22
NSC 18 - Medical Devices and Facilities for Healthcare
