Reference number
ISO 15198:2004
© ISO 2024
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
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Published (Edition 1, 2004)
This publication was last reviewed and confirmed in 2018. Therefore this version remains current.

ISO 15198:2004

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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

  • Status
     : Published
    Publication date
     : 2004-07
    Stage
    : Withdrawal of International Standard proposed by TC or SC [90.99]
  • Edition
     : 1
    Number of pages
     : 10
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
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