03/318598 DC : DRAFT NOV 2003
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ISO TS 19218 - MEDICAL DEVICES - CODING SYSTEM FOR ADVERSE EVENT REPORTING
23-11-2012
21-12-2005
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
3.1 Adverse event
3.2 Adverse event cause
3.3 Adverse event type
3.4 Device nomenclature code
3.5 Device type
3.6 Patient/user outcome code
4 Coding system structure
5 Coding system requirements
5.1 Device nomenclature code
5.2 Device type
5.3 Adverse event type code
5.4 Adverse event cause code
5.5 Patient/user outcome code
6 Coding system for adverse event reporting
Tables
Annex A (informative) Bibliography
ISO TS 19218
| Committee |
CH/210/3
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 15225:2016 | Medical devices — Quality management — Medical device nomenclature data structure |
| ISO/TS 20225:2001 | Global medical device nomenclature for the purpose of regulatory data exchange |