AAMI ISO TIR 19218-2 : 2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 2: EVALUATION CODES
Hardcopy , PDF
English
01-01-2012
15-07-2018
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO/TS 19218-2:2012
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Adverse event evaluation code requirements
4 Adverse event evaluation codes
Annex A - 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 |
ISO/TC 210
|
| DevelopmentNote |
Supersedes AAMI ISO TIR 19218. (12/2012)
|
| DocumentType |
Standard
|
| ISBN |
1-57020-469-1
|
| Pages |
32
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| 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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