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
Published (Edition 1, 2004)

ISO 15198:2004

Language
Format
CHF 63
Convert Swiss francs (CHF) to your currency

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 ballot initiated [95.20]
  • Edition
     : 1
    Number of pages
     : 10
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.10 
  • RSS updates

Life cycle

Got a question?

Check out our Help and Support

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.100
  7. 11.100.10
  8. ISO 15198:2004