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About This Item

 

Full Description

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.

 

Document History

  1. ISO/TS 19218-1:2011

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    Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes

    • Most Recent
  2. ISO/TS 19218:2005


    Medical devices - Coding structure for adverse event type and cause

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO/TS 19218-1:2011/Amd1:2013


    Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes- Amendment 1