Abstract Preview

ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. They can also be used for coding the results of the analysis or evaluation of events other than those related to death or serious injury, as well as malfunctions that could lead to death or serious injury.

ISO/TS 19218-2:2012 is not intended to be used to decide whether or not an incident is reportable.


General information

  • Status :  Published
    Publication date : 2012-04
  • Edition : 1
    Number of pages : 13
  • :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • 11.040.01
    Medical equipment in general
    03.120.10
    Quality management and quality assurance

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