DD ISO/TS 19218-1 : 2011
Current
The latest, up-to-date edition.
MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES
Hardcopy , PDF
English
01-01-2011
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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
Describes requirements for a hierarchical coding structure for describing adverse events relating to medical devices.
| Committee |
CH/210/3
|
| DevelopmentNote |
Together with BS PD ISO TS 19218-2, it supersedes DD ISO/TS 19218. (05/2012) 2011 Edition Re-Issued in April 2013 & incorporates AMD 1 2013. (04/2013)
|
| DocumentType |
Draft
|
| Pages |
28
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| 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 15225:2016 | Medical devices Quality management Medical device nomenclature data structure |
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