Reference number
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218-1:2011
Technical Specification
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218-1:2011
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
Edition 1
2011-05
Withdrawn
Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218-1:2011
55589
Withdrawn (Edition 1, 2011)

Abstract

Ïã¸ÛÁùºÏ²Ê¿ª½±/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.

Ïã¸ÛÁùºÏ²Ê¿ª½±/TS 19218-1:2011 is not intended to be used to decide whether an incident is reportable or not.

General information

Life cycle

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