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ISO 15198:2004

Current Date published:

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

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.

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Related Information

Similar Standards

  • BS EN 13532:2002

    General requirements for in vitro diagnostic medical devices for self-testing

  • BS EN 13612:2002

    Performance evaluation of in vitro diagnostic medical devices

  • BS EN 13641:2002

    Elimination or reduction of risk of infection related to in vitro diagnostic reagents

  • BS EN 13975:2003

    Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

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ISO 15198:2004

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PDF ( Single user document)
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