ISO-19218-1 › Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
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1ST EDITION - May 15, 2011
FOR 1ST EDITION AMENDMENT 1 SEE - Jan. 15, 2013
FOR 1ST EDITION AMENDMENT 1 SEE - Jan. 15, 2013
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.
To find similar documents by classification:
03.120.10 (Quality management and quality assurance)
11.040.01 (Medical equipment in general)
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Document Number
ISO/TS 19218-1:2011
Revision Level
1ST EDITION
Status
Current
Publication Date
May 15, 2011
Committee Number
ISO/TC 210