DS ISO/TS 19218-2:2012

Pajisje mjekësore - Struktura hierarkike e kodimit për raste të pafavorshme - Pjesa 2: Vlerësimi i kodeve

Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes

Publication date: 27 nën 2015

General information

Current stage: 60.60 Effective date: 27 nën 2015

Originator: DPS

Owner: DPS/KT 316

Type: Technical Specification

ICS: 03.120.10 11.040.01

Gjuha: anglisht

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Statusi: Publikuar

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Scope

ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. They can also be used for coding the results of the analysis or evaluation of events other than those related to death or serious injury, as well as malfunctions that could lead to death or serious injury.
ISO/TS 19218-2:2012 is not intended to be used to decide whether or not an incident is reportable.

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PUBLISHED
DS ISO/TS 19218-2:2012
60.60 Standard published
27 nën 2015

Related project

Adopted from ISO/TS 19218-2:2012

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