Standard

ISO/TS 19218-1:2011

May 2011 Withdrawn

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Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1 Withdrawn ISO/TS 19218-1:2011/Amd 1:2013 Amendment from Publication date: Jan 2013 Pages: 7 Language: English Services: Online, Online + Pdf

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.

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Standard from ISO
Published: May 5 2011
Withdrawn: October 2 2020
Edition: 1
Document type: TS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 03.120.10
ICS: 11.040.01
International TC: ISO/TC 210

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Revises: ISO/TS 19218:2005

ISO/TS 19218-1:2011

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