Name: AAMI ISO TIR 19218-1 : 2011
Brand: AAMI

AAMI ISO TIR 19218-1 : 2011

Superseded

View Superseded by

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

Available format(s)

Hardcopy , PDF

Superseded date

09-13-2021

Language(s)

English

Published date

08-10-2011

Publisher

Association for the Advancement of Medical Instrumentation

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Status	Superseded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	ANSI/AAMI/ ISO TIR 19218-1:2011 & A1:2013
Supersedes	AAMI ISO TIR 19218 : 2005

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