ISO/TS 19218-1:2011

Name: ISO/TS 19218-1:2011
Brand: ISO
SKU: ISO/TS 19218-1:2011
Price: 81.07 EUR
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Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes ISO/TS 19218-1:2011

Publication date: May 5, 2011

95.99 Withdrawal of Standard Oct 2, 2020

General information

Current stage: 95.99 Withdrawal of Standard Oct 2, 2020

Originator: ISO

Owner: ISO/TC 210 Quality management and corresponding general aspects for medical devices

Type: Technical Specification

ICS: 03.120.10 Quality management and quality assurance | 11.040.01 Medical equipment in general

Buying

Status: Withdrawn

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

WITHDRAWN
ISO/TS 19218:2005

NOW

WITHDRAWN
ISO/TS 19218-1:2011
95.99 Withdrawal of Standard
Oct 2, 2020

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO/TS 19218-1:2011/Amd 1:2013