ISO 15198:2004 (R2018)
Withdrawn , Reaffirmed Standard
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ISO 15198:2004 (R2018)

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

Summary

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.

Notes

90.60 : Clôture de l'examen

Technical characteristics

Publisher International Organization for Standardization (ISO)
Publication Date 07/16/2004
Confirmation Date 12/04/2018
Edition 1
Page Count 10
EAN ---
ISBN ---
Weight (in grams) ---
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