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
BHD 31.94

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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