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ISO/TS 19218-2:2012

Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
20 mar 2012
95.99 Withdrawal of Standard   2 tet 2020

General information

95.99     2 tet 2020

ISO

ISO/TC 210

Technical Specification

03.120.10     11.040.01  

anglisht  

Buying

Shfuqizuar

Language in which you want to receive the document.

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/TS 19218:2005

NOW

WITHDRAWN
ISO/TS 19218-2:2012
95.99 Withdrawal of Standard
2 tet 2020

National adoptions

DS ISO/TS 19218-2:2012  
DPS

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

60.60 Standard published

DPS/KT 316 më tepër