ISO 18153:2003
(Main)In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 18153:2003 specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement of the catalytic concentration of enzymes. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. The following subjects are outside the scope of ISO 18153:2003: requirements for the design or selection of a reference measurement procedure; quantities involving mass of enzyme or immunoreactivity of enzymes; control materials that do not have an assigned value and are used only for assessing the precision of a measurement procedure, either its repeatability or reproducibility (precision control materials); control materials intended for intralaboratory quality control purposes and supplied with intervals of suggested acceptable values, each interval obtained by interlaboratory consensus with respect to one specified measurement procedure, and with limiting values that are not metrologically traceable; metrological traceability of routine results to the product calibrator and their relations to any medical discrimination limit; properties involving nominal and ordinal scales.
Dispositifs médicaux de diagnostic in vitro — Mesurage des grandeurs dans des échantillons d'origine biologique — Traçabilité métrologique des valeurs de concentration catalytique des enzymes attribuées aux agents d'étalonnage et aux matériaux de contrôle
General Information
Relations
Buy Standard
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 18153
First edition
2003-08-15
In vitro diagnostic medical devices —
Measurement of quantities in biological
samples — Metrological traceability of
values for catalytic concentration of
enzymes assigned to calibrators and
control materials
Dispositifs médicaux de diagnostic in vitro — Mesurage des grandeurs
dans des échantillons d’origine biologique — Traçabilité métrologique
des valeurs de concentration catalytique des enzymes attribuées aux
agents d’étalonnage et aux matériaux de contrôle
Reference number
ISO 18153:2003(E)
©
ISO 2003
---------------------- Page: 1 ----------------------
ISO 18153:2003(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2003
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2003 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 18153:2003(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 18153 was prepared by the European Committee for Standardization (CEN) in collaboration with
Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
Throughout the text of this document, read ".this European Standard." to mean ".this International
Standard.".
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council
Directives has been removed.
© ISO 2003 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 18153:2003(E)
Contents
page
Foreword.v
Introduction .vi
1 Scope .1
2 Normative references .1
3 Terms and definitions.1
4 Metrolo
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.