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


Document Number: ISO 15198:2004
File Size: 171 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section

Price: $76.00
Product Details

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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