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)

ISO 15193:2009 specifies requirements for the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.
ISO 15193:2009 applies to reference measurement procedures providing values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15193:2009 is valid for any person, body or institution involved in one of the various branches of laboratory medicine whose intention is to write a document to serve as a reference measurement procedure.

In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs - Anforderungen an den Inhalt und die Darstellung von Referenzmessverfahren (ISO 15193:2009)

Diese Internationale Norm legt Anforderungen an den Inhalt eines Referenzmessverfahrens für In-vitro-Diagnostika und medizinische Labore fest.
ANMERKUNG 1   Es ist vorgesehen, dass ein erfahrener Laborant, der sich an die in Übereinstimmung mit der Internationalen Norm schriftlich festgehaltenen Verfahrensweisen hält, Messergebnisse produzieren kann, deren Messunsicherheit den festgesetzten Bereich nicht überschreitet.
Diese Internationale Norm gilt für Referenzmessverfahren, die Werte für Differenz  oder Teilmengen liefern. Anhang A enthält Informationen über nominale Eigenschaften und Ordinalmengen.
Diese Internationale Norm gilt für alle Personen, Körperschaften oder Institutionen, die in einen der verschiedenen labormedizinischen Bereiche eingebunden sind und beabsichtigen, ein Dokument zu schreiben, das als Referenzmessverfahren dienen soll.
Vollständige Beschreibungen von Messverfahren werden üblicherweise in der wissenschaftlichen Literatur veröffentlicht die Verfahrensweisen detailliert genug beschrieben werden, damit diese als Grundlage eines dokumentierten Messverfahrens verwendet werden können.
ANMERKUNG 2   In dieser Internationalen Norm bezeichnet der Begriff „Internationale Messnorm“ eine Materialnorm. Der Begriff „internationale Norm“ wird von der WGO für Referenzmaterialien verwendet.

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 (ISO 15193:2009, version corrigée 2009-09-15 inclus)

L'ISO 15193:2009 spécifie les exigences relatives au contenu d'une procédure de mesure de référence pour les dispositifs médicaux de diagnostic in vitro et les laboratoires d'analyses de biologie médicale.
L'ISO 15193:2009 s'applique à des procédures de mesure de référence permettant d'obtenir des grandeurs différentielles ou proportionnelles.
L'ISO 15193:2009 est applicable à toute personne, tout organisme ou toute institution, impliqué dans l'une des branches de la biologie médicale, qui a l'intention de rédiger un document qui servira de procédure de mesure de référence.

Diagnostični medicinski pripomočki in vitro - Merjenje količin v vzorcih biološkega izvora - Zahteve za vsebino in predstavitev referenčnih merilnih postopkov (ISO 15193:2009)

General Information

Status
Published
Publication Date
30-Apr-2009
Withdrawal Date
29-Apr-2012
Current Stage
9092 - Decision on results of review/2YR ENQ - revise - Review Enquiry
Completion Date
03-Sep-2014

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15193:2009
01-julij-2009
'LDJQRVWLþQLPHGLFLQVNLSULSRPRþNLLQYLWUR0HUMHQMHNROLþLQYY]RUFLKELRORãNHJD
L]YRUD=DKWHYH]DYVHELQRLQSUHGVWDYLWHYUHIHUHQþQLKPHULOQLKSRVWRSNRY ,62

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
SIST EN ISO 15193:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15193:2009

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SIST EN ISO 15193:2009
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.

---------------------- Page: 3 ----------------------

SIST EN ISO 15193:2009
EN ISO 15193:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 98/79 .4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 15193:2009
EN ISO 15193:2009 (E)
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.
...

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---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
DRAFT
prEN ISO 15193
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2006
ICS

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/DIS
15193:2006)
Dispositifs médicaux de diagnostic in vitro - Mesurage des
grandeurs dans des échantillons d'origine biologique -
Exigences relatives au contenu et à la présentation des
modes opératoires de mesure de référence (ISO/DIS
15193:2006)
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 140.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 15193:2006: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------
prEN ISO 15193:2006 (E)




Foreword

This document (prEN ISO 15193:2006) 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 document is currently submitted to the parallel Enquiry.

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 EU Directive(s).

2

---------------------- Page: 3 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 15193
ISO/TC 212 Secretariat: ANSI
Voting begins on: Voting terminates on:
2006-08-10 2007-01-10
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
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 modes opératoires de mesure de
référence
[Revision of first edition (ISO 15193:2002)]
ICS 11.100.10

ISO/CEN PARALLEL ENQUIRY
This draft International Standard is a draft standard developed within the European Committee for
Standardization (CEN) and processed under the CEN-lead mode of collaboration as defined in the
Vienna Agreement. The document has been transmitted by CEN to ISO for circulation for ISO member
body voting in parallel with CEN enquiry. Comments received from ISO member bodies, including those
from non-CEN members, will be considered by the appropriate CEN technical body. Should thi
...

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