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DS ISO/TS 19218-1:2011

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

Nov 27, 2015

General information

60.60     Nov 27, 2015

DPS

DPS/KT 316

Technical Specification

03.120.10     11.040.01  

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Scope

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.

Life cycle

PREVIOUSLY

Replaces
SSH ISO/TS 19218:2007

NOW

PUBLISHED
DS ISO/TS 19218-1:2011
60.60 Standard published
Nov 27, 2015

Related project

Adopted from ISO/TS 19218-1:2011

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