GSO ISO 15198:2016
ISO 15198:2004
Gulf Standard
Current Edition
·
Approved on
22 December 2016
Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
GSO ISO 15198:2016 Files
English
10 Pages
Current Edition
Reference Language
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GSO ISO 15198:2016 Scope
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.
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