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.
Revises
ISO/TS 19218:2005
WITHDRAWN
ISO/TS 19218-1:2011
95.99
Withdrawal of Standard
Oct 2, 2020
Amended by
ISO/TS 19218-1:2011/Amd 1:2013
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
60.60 Standard published
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