EN ISO 15194:2009
(Main)In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs - Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt der Begleitdokumentation (ISO 15194:2009)
Diese Internationale Norm legt Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt ihrer Begleitdokumentation fest, um von diesen als von höherer metrologischer Ordnung nach ISO 17511 berücksichtigt zu werden. Sie gilt für zertifizierte Referenzmaterialien, die als Primärmessnormen, Sekundärmessnormen und international vereinbarte Kalibriermittel eingestuft werden können, die entweder als Kalibriermittel oder Richtigkeitskontrollmaterialien funktionieren. Diese Internationale Norm stellt ferner
Anforderungen bereit, wie Daten zur Ermittlung der Werte zu sammeln sind und wie der zugeordnete Wert und dessen Messunsicherheit darzustellen sind.
Die vorliegende Internationale Norm gilt für zertifizierte Referenzmaterialien mit zugeordneten Werten unterschiedlicher oder rationaler Mengen. Anhang A enthält Informationen über Nominaleigenschaften und Ordinalgrößen.
Diese Internationale Norm gilt nicht für Referenzmaterialien, die Bestandteil eines Messsystems zur In-vitro-Diagnose sind, obwohl zahlreiche Elemente hilfreich sein können
Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans les échantillons d'origine biologique - Exigences relatives aux matériaux de référence certifiés et au contenu de la documentation associée (ISO 15194:2009)
L'ISO 15194:2009 spécifie des exigences concernant les matériaux de référence certifiés (MRC) et le contenu de la documentation qui leur est associée afin qu'ils soient considérés comme étant de niveau métrologique supérieur conformément à l'ISO 17511. Elle s'applique aux MRC qui peuvent être classés en tant qu'étalons primaires, étalons secondaires et étalons conventionnels internationaux qui font fonction soit d'étalons, soit de matériaux de contrôle de la justesse. L'ISO 15194:2009 contient également des exigences sur la façon dont les données doivent être recueillies pour la détermination de valeurs et sur le mode de présentation de la valeur assignée et de son incertitude de mesure.
L'ISO 15194:2009 s'applique aux MRC auxquels sont associées des grandeurs différentielles ou proportionnelles ayant une valeur assignée. Concernant les propriétés et les grandeurs ayant des valeurs exprimées sur une échelle nominale ou ordinale, voir l'Annexe A.
L'ISO 15194:2009 ne s'applique pas aux matériaux de référence qui font partie d'un système de diagnostic in vitro bien que de nombreux éléments puissent être utiles.
Diagnostični medicinski pripomočki in vitro - Merjenje količin v vzorcih biološkega izvora - Zahteve za certificirane referenčne materiale in vsebino podporne dokumentacije (ISO 15194:2009)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2009
'LDJQRVWLþQLPHGLFLQVNLSULSRPRþNLLQYLWUR0HUMHQMHNROLþLQYY]RUFLKELRORãNHJD
L]YRUD=DKWHYH]DFHUWLILFLUDQHUHIHUHQþQHPDWHULDOHLQYVHELQRSRGSRUQH
GRNXPHQWDFLMH ,62
In vitro diagnostic medical devices - Measurement of quantities in samples of biological
origin - Requirements for certified reference materials and the content of supporting
documentation (ISO 15194:2009)
In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs -
Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt der
Begleitdokumentation (ISO 15194:2009)
Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans les
échantillons d'origine biologique - Exigences pour les matériaux de référence certifiés et
pour le contenu de la documentation justificative (ISO 15194:2009)
Ta slovenski standard je istoveten z: EN ISO 15194:2009
ICS:
11.100.10 'LDJQRVWLþQLSUHVNXVQL In vitro diagnostic test
VLVWHPLLQYLWUR systems
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15194
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.100.10
English Version
In vitro diagnostic medical devices - Measurement of quantities
in samples of biological origin - Requirements for certified
reference materials and the content of supporting
documentation (ISO 15194:2009)
Dispositifs médicaux de diagnostic in vitro - Mesurage des In-Vitro-Diagnostika - Messung von Größen in Proben
grandeurs dans les échantillons d'origine biologique - biologischen Ursprungs - Anforderungen an zertifizierte
Exigences relatives aux matériaux de référence certifiés et Referenzmaterialien und an den Inhalt der
au contenu de la documentation associée (ISO Begleitdokumentation (ISO 15194:2009)
15194:2009)
This European Standard was approved by CEN on 16 April 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15194:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 98/79 .4
Foreword
This document (EN ISO 15194:2009) has been prepared by Technical Committee CEN/TC 140 "In vitro
diagnostic medical devices", the secretariat of which is held by DIN, in collaboration with Technical Committee
ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems".
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by November 2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Annex ZA
(informative)
Relationship between this International Standard and the Essential Requirements
of EU Directive 98/79
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 98/79.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 15194
Second edition
2009-05-01
In vitro diagnostic medical devices —
Measurement of quantities in samples of
biological origin — Requirements for
certified reference materials and the
content of supporting documentation
Dispositifs médicaux de diagnostic in vitro — Mesurage des grandeurs
dans les échantillons d'origine biologique — Exigences relatives aux
matériaux de référence certifiés et au contenu de la documentation
associée
Reference number
ISO 15194:2009(E)
©
ISO 2009
ISO 15194:2009(E)
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ii © ISO 2009 – All rights reserved
ISO 15194:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Systematic format of properties in the supporting documentation of a certified reference
material . 4
4.1 Format of properties. 4
4.2 Construction of systematic designations . 5
4.3 Trivial names . 5
5 Properties, production, and characterization of a certified reference material . 5
5.1 Hierarchical position . 5
5.2 Properties . 5
5.3 Production and characterization. 6
6 Content of supporting documentation . 6
6.1 Supporting documentation. 6
6.2 Label. 6
6.3 Certificate . 6
6.4 Certification report. 7
Annex A (informative) Certified reference materials with nominal properties or ordinal quantities. 15
Bibliography . 16
ISO 15194:2009(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 15194 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 140, In vitro diagnostic medical devices, 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).
This second edition cancels and replaces the first edition (ISO 15194:2002), which has been technically
revised.
iv © ISO 2009 – All rights reserved
ISO 15194:2009(E)
Introduction
Reference measurement systems are needed to produce useful and reliable measurement results, whether in
science, technology or routine service, so as to be comparable and ultimately metrologically traceable to
measurement standards and/or measurement procedures of the highest metrological level.
Substances or devices that are used to obtain this metrological traceability, through time, distances and
different measurement procedures, are reference materials. Certified reference materials are needed at the
higher metrological levels of a calibration hierarchy.
A given certified reference material is supported by documentation containing sources of material,
descriptions, measurement results, metrological traceability, instructions for use, stability data and storage
conditions, as well as health and safety warnings. This International Standard specifies the quality
requirements f
...
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