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ISO TS 19218-2

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

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Organization: ISO
Publication Date: 1 April 2012
Status: active
Page Count: 20
ICS Code (Quality management and quality assurance): 03.120.10
ICS Code (Medical equipment in general): 11.040.01
scope:

This part of ISO 19218 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.

This part of ISO 19218 is not intended to be used to decide whether or not an incident is reportable.

Document History

ISO TS 19218-2
April 1, 2012
Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
This part of ISO 19218 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...

References

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