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DD ISO/TS 19218-1 : 2011

DD ISO/TS 19218-1 : 2011

Current

Current

The latest, up-to-date edition.

MEDICAL DEVICES - HIERARCHICAL CODING STRUCTURE FOR ADVERSE EVENTS - PART 1: EVENT-TYPE CODES

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2011

Publisher

British Standards Institution

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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Hardcopy - English
PDF - English
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