ISO-19218-2 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes

ISO-19218-2 - 1ST EDITION - CURRENT


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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.

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03.120.10 (Quality management and quality assurance)

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Document Number

ISO/TS 19218-2:2012

Revision Level

1ST EDITION

Status

Current

Publication Date

April 1, 2012

Committee Number

ISO/TC 210