DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

DS ISO/TS 19218-2:2012

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

Nov 27, 2015

General information

60.60     Nov 27, 2015

DPS

DPS/KT 316

Technical Specification

03.120.10     11.040.01  

English  

Buying

Published

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

NOW

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

Related project

Adopted from ISO/TS 19218-2:2012

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.

Login