PD ISO/TS 19218-2:2012
Withdrawn
Medical devices. Hierarchical coding structure for adverse events Evaluation codes
Hardcopy , PDF
English
05-31-2012
07-04-2024
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Adverse-event evaluation code requirements
4 Adverse-event evaluation codes
Annex A (informative) - Coding system structure
Bibliography
Describes requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices.
| Committee |
CH/210/3
|
| DevelopmentNote |
Together with DD ISO/TS 19218-1, it supersedes DD ISO/TS 19218. (05/2012)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
This part of ISO19218 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 ISO19218 is not intended to be used to decide whether or not an incident is reportable.
| Standards | Relationship |
| ISO/TS 19218-2:2012 | Identical |
| ISO/TS 19218-1:2011 | Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 15225:2016 | Medical devices — Quality management — Medical device nomenclature data structure |
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