ISO 15198:2004

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

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.

Laboratoires d'analyses de biologie médicale — Dispositifs médicaux de diagnostic in vitro — Validation des recommandations du fabricant pour la maîtrise de la qualité par l'utilisateur

General Information

• Status: Published
• Publication Date: 15-Jul-2004
• ICS: 11.100.10 - In vitro diagnostic test systems
• Technical Committee: ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
• Drafting Committee: ISO/TC 212/WG 3 - In vitro diagnostic products
• Current Stage: 9060 - Close of review
• Start Date: 04-Jun-2029

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 15198
First edition
2004-07-15
Clinical laboratory medicine — In vitro
diagnostic medical devices — Validation
of user quality control procedures by the
manufacturer
Laboratoires d'analyses de biologie médicale — Dispositifs médicaux de
diagnostic in vitro — Validation des recommandations du fabricant pour
la maîtrise de la qualité par l'utilisateur

Reference number
ISO 15198:2004(E)
©
ISO 2004

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ISO 15198:2004(E)
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ii ISO 2004 – All rights reserved

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ISO 15198:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15198 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic
test systems.
©
ISO 2004 – All rights reserved iii

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ISO 15198:2004(E)
Introduction
Manufacturers of IVD medical devices often include quality control (QC) procedures in their instructions for use.
These quality control procedures are intended to provide users with assurance that the device is performing
within specifications, and therefore the results are suitable for their intended diagnostic use. For some devices,
QC procedures can be an essential risk control measure. Depending on the design of the device, these quality
control procedures can help users ensure the quality of results by:
a) verifying the suitability of analytical systems (sample, reagents, instruments, and/or users);
b) monitoring the precision and trueness of measurement results;
c) preventing false-negative and false-positive results;
d) identifying fault conditions that could lead to inaccurate results; and/or
e) troubleshooting problems that require corrective action.
In addition, manufacturers often design IVD medical devices with the ability to detect potential failures and alert
users to take corrective action. Such internal control systems could potentially reduce or even eliminate the
need for users to run quality control samples to monitor the performance of the device.
This International Standard is written for manufacturers of in vitro diagnostic (IVD) medical devices as part of
their design control and risk management programs. It will also enable manufacturers to provide validated
quality control procedures for users in clinic
...