EN ISO 15193:2009

SLOVENSKI STANDARD
01-julij-2009
'LDJQRVWLþQLPHGLFLQVNLSULSRPRþNLLQYLWUR0HUMHQMHNROLþLQYY]RUFLKELRORãNHJD
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In vitro diagnostic medical devices - Measurement of quantities in samples of biological
origin - Requirements for content and presentation of reference measurement
procedures (ISO 15193:2009)
In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs -
Anfor¬derungen Inhalt und Aufbereitung von Referenzmessverfahren (ISO 15193:2009)
Dispositifs médicaux de diagnostic in vitro - Mesurage des grandeurs dans des
échantillons d'origine biologique - Exigences relatives au contenu et a la présentation
des modes opératoires de mesure de référence (ISO 15193:2009)
Ta slovenski standard je istoveten z: EN ISO 15193:2009
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 15193
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 content and
presentation of reference measurement procedures (ISO
15193:2009)
Dispositifs médicaux de diagnostic in vitro - Mesurage des In-vitro-Diagnostika - Messung von Größen in Proben
grandeurs dans des échantillons d'origine biologique - biologischen Ursprungs - Anforderungen an den Inhalt und
Exigences relatives au contenu et à la présentation des die Darstellung von Referenzmessverfahren (ISO
procédures de mesure de référence (ISO 15193:2009) 15193:2009)
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 15193:2009: 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 15193:2009) 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 15193
Second edition
2009-05-01
In vitro diagnostic medical devices —
Measurement of quantities in samples of
biological origin — Requirements for
content and presentation of reference
measurement procedures
Dispositifs médicaux de diagnostic in vitro — Mesurage des grandeurs
dans des échantillons d'origine biologique — Exigences relatives au
contenu et à la présentation des procédures de mesure de référence

Reference number
ISO 15193:2009(E)
©
ISO 2009
ISO 15193:2009(E)
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ISO 15193:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Presentation of a reference measurement procedure . 4
4.1 Elements of a reference measurement procedure . 4
4.2 Warning and safety precautions . 4
4.3 Introduction . 5
4.4 Scope . 5
4.5 Terms, definitions, symbols and abbreviated terms. 5
4.6 Measurement principle and measurement method. 6
4.7 Check list . 6
4.8 Reagents and materials . 7
4.9 Apparatus . 9
4.10 Sampling and sample. 9
4.11 Preparation of measuring system and analytical portion . 9
4.12 Operation of measuring system. 11
4.13 Data processing. 11
4.14 Analytical reliability . 12
4.15 Special cases . 15
4.16 Validation of a reference measurement procedure. 15
4.17 Reporting . 15
4.18 Quality assurance. 16
4.19 Bibliography . 16
4.20 Dates of authorization and revision. 16
Annex A (informative) Reference procedures for properties other than differential and rational
quantities . 17
Bibliography . 18

ISO 15193:2009(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 15193 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 15193:2002), which has been technically
...