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ISO/TS 19218-1:2011

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

09-23-2021

Published date

05-05-2011

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.

DevelopmentNote
Together with ISO TS 19218-2, Supersedes ISO TS 19218. (03/2012)
DocumentType
Technical Specification
Pages
15
ProductNote
THIS STANDARD ALSO REFERS TO GHTF/SG1/N41/R9:2005, GHTF/SG2/N21/R8:1999,GHTF/SG2/N31/R8:2003,GHTF/SG2/N54/R8:2006
PublisherName
International Organization for Standardization
Status
Withdrawn
Supersedes

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