Reference number
ISO 15198:2004
International Standard
ISO 15198:2004
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
Edition 1
2004-07
Read sample
ISO 15198:2004
39751
Published (Edition 1, 2004)
This publication was last reviewed and confirmed in 2018. Therefore this version remains current.

ISO 15198:2004

ISO 15198:2004
39751
Language
Format
CHF 63
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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

  •  : Published
     : 2004-07
    : Close of review [90.60]
  •  : 1
     : 10
  • ISO/TC 212
    11.100.10 
  • RSS updates

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