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

ISO 15198:2014

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

This international 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. ISO 15198:2014 applies to all in vitro diagnostic medical devices.

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Publication Details

Date of Publication: July 1, 2004

Order Code PDF: ISO15198E

Order Code Print: print not available

Edition: First

Pages: 10

ISO 15198:2014 Additional Details

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems