PD ISO/TS 19218-2:2012 PDF

1   Scope This part of ISO 19218 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 . This part of ISO 19218 is not intended to be used to decide whether or not an incident is reportable.