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ISO 15198:2004

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

Jul 16, 2004

General information

90.60     Mar 4, 2024

ISO

ISO/TC 212

International Standard

11.100.10  

English  

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Published

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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.

Life cycle

NOW

PUBLISHED
ISO 15198:2004
90.60 Close of review
Mar 4, 2024

National adoptions

SSH ISO 15198:2007  
DPS

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

60.60 Standard published

DPS/KT 1 more