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PD ISO/TS 19218-2:2012

Current
Current

The latest, up-to-date edition.

Medical devices. Hierarchical coding structure for adverse events Evaluation codes
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-31-2012

Publisher

British Standards Institution

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.

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.

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
Current
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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PDF - English
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