ISO/TS 19218-1:2011 Preview

Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes

ISO/TS 19218-1:2011 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizations. The codes can be used for coding events that are not related to death or serious injury, or malfunctions that could lead to death or serious injury.

ISO/TS 19218-1:2011 is not intended to be used to decide whether an incident is reportable or not.


General information

  • Status :  Published
    Publication date : 2011-05
  • Edition : 1
    Number of pages : 15
  • :
    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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