International Standard
ISO 15198:2004
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
Reference number
ISO 15198:2004
ISO 15198:2004
Edition 1
2004-07
2004-07
© ISO 2024
International Standard
p
ISO 15198:2004
39751
Published
(Edition 1, 2004)
This standard was last reviewed and confirmed in 2018.
Therefore this version remains current.
Abstract
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.
General information
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Status: PublishedPublication date: 2004-07Stage: Close of review [90.60]
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Edition: 1Number of pages: 10
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Technical Committee :ISO/TC 212ICS :11.100.10
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