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SSH ISO 15198:2007

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

Jan 1, 2007

General information

60.60     Jan 1, 2007

DPS

DPS/KT 1

International Standard

11.100.10  

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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
SSH ISO 15198:2007
60.60 Standard published
Jan 1, 2007

Related project

Adopted from ISO 15198:2004