DD ISO/TS 19218-1:2011+A1:2013
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
04-07-2024
English
31-05-2013
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/210/3
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| DocumentType |
Standard
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| Pages |
28
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| PublisherName |
British Standards Institution
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| Status |
Withdrawn
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| 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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