BH GSO ISO 15198:2017
ISO 15198:2004
Bahraini Standard
Current Edition
·
Approved on
21 June 2017
Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer
BH GSO ISO 15198:2017 Files
English
10 Pages
Current Edition
Reference Language
BHD
30.42
BH GSO ISO 15198:2017 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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