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DD ISO/TS 19218-1:2011+A1:2013

DD ISO/TS 19218-1:2011+A1:2013

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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

Available format(s)

Hardcopy , PDF

Withdrawn date

04-07-2024

Language(s)

English

Published date

31-05-2013

Publisher

British Standards Institution

Committee
CH/210/3
DocumentType
Standard
Pages
28
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes
UnderRevision

This part of ISO/TS19218 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.

This part of ISO/TS19218 is not intended to be used to decide whether an incident is reportable or not.

Standards Relationship
ISO/TS 19218-1:2011 Identical

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Hardcopy - English
PDF - English
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