Standard

ISO/TS 19218-2:2012

Mar 2012 Withdrawn

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Language English

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Abstract

ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. They can also be used for coding the results of the analysis or evaluation of events other than those related to death or serious injury, as well as malfunctions that could lead to death or serious injury. ISO/TS 19218-2:2012 is not intended to be used to decide whether or not an incident is reportable.

Products specifications

Standard from ISO
Published: March 20 2012
Withdrawn: October 2 2020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

Product Relations

Revises: ISO/TS 19218:2005

ISO/TS 19218-2:2012

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