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.
Status: WithdrawnPublication date: 2011-05
Edition: 1Number of pages: 15
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for medical devices
ISO/TS 19218-1:2011Stage: 95.99
Corrigenda / AmendmentsWithdrawn
ISO/TS 19218-1:2011/Amd 1:2013
Got a question?
Check out our FAQs
+41 22 749 08 88
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.