Skip to main content
Back

ISO 15198:2004

Clinical laboratory medicine -- In vitro diagnostic medical devices -- Validation of user quality control procedures by the manufacturer

General information

Withdrawn from 24.02.2025
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.07.2004
Main
ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.

Required fields are indicated with *

*
*
*
*
PDF
89.37 € incl tax
Paper
89.37 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices
Newest version Valid from 01.09.2002
Main

ISO 20916:2019

In vitro diagnostic medical devices -- Clinical performance studies using specimens from human subjects -- Good study practice
Newest version Valid from 04.06.2019
Main

ISO 23640:2011

In vitro diagnostic medical devices -- Evaluation of stability of in vitro diagnostic reagents
Newest version Valid from 29.11.2011
Main

EVS-EN ISO 18113-1:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Withdrawn from 15.07.2024