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AAMI ISO TIR 19218-1 : 2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Superseded date

13-09-2021

Language(s)

English

Published date

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Superseded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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