ISO-15198 › Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

ISO-15198 - 1ST EDITION - CURRENT


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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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11.100 (Laboratory medicine)

11.100.10 (In vitro diagnostic test systems)

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Document Number

ISO 15198:2004

Revision Level

1ST EDITION

Status

Current

Publication Date

July 15, 2004

Committee Number

ISO/TC 212