AAMI ISO TIR 19218-1 : 2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 - HIERARCHAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES
Hardcopy , PDF
13-09-2021
English
10-08-2011
Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO/TS 19218-1:2011
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Adverse-event-type code requirements
4 Adverse-event-type codes
Annex A (informative) - Coding-system structure
Annex B (informative) - Examples of event-type code
selection
Bibliography
This part of ISO/TS 19218 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices.
| Committee |
ISO/TC 210
|
| DevelopmentNote |
Supersedes AAMI ISO TIR 19218. (11/2011)
|
| DocumentType |
Technical Report
|
| ISBN |
157020424-1
|
| Pages |
64
|
| ProductNote |
NEW CHILD AMD 1 2013 IS NOW ADDED.
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO/TS 19218-1:2011 | Identical |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO/TS 19218-2:2012 | Medical devices Hierarchical coding structure for adverse events Part 2: Evaluation codes |
| ISO 15225:2016 | Medical devices Quality management Medical device nomenclature data structure |
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