DD ISO/TS 19218-1:2011+A1:2013

This standard DD ISO/TS 19218-1:2011+A1:2013 Medical devices. Hierarchical coding structure for adverse events is classified in these ICS categories:

• 11.040.01 Medical equipment in general
• 03.120.10 Quality management and quality assurance

This part of ISO/TS 19218 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.

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