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ISO/TS 19218-1:2011

Medical devices -- Hierarchical coding structure for adverse events -- Part 1: Event-type codes

General information

Withdrawn from 02.10.2020
ICS Groups
03.120.10 Quality management and quality assurance 11.040.01 Medical equipment in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
08.01.2013
Amendment
ISO/TS 19218-1:2011/Amd 1:2013
05.05.2011
Main
ISO/TS 19218-1:2011
Main
ISO/TS 19218:2005
ISO/TS 19218-1:2011 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizations. The codes can be used for coding events that are not related to death or serious injury, or malfunctions that could lead to death or serious injury.
ISO/TS 19218-1:2011 is not intended to be used to decide whether an incident is reportable or not.

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Standard monitoring
English (PDF 154 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English