Abstract 

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  • Status :  Withdrawn
    Publication date : 2011-05
  • Edition : 1
    Number of pages : 15
  • :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • 03.120.10
    Quality management and quality assurance
    11.040.01
    Medical equipment in general

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
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.