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CEN

EN 12286:1998

(Main)

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

This European Standard specifies requirements for the drafting of a reference measurement procedure.  NOTE: It is intended that an experienced laboratory worker, following a measurement procedure written in accordance with this European Standard can be expected to produce results with an uncertainty of measurement not exceeding the stipulated range.  This European Standard is applicable to any person, body, or institution, involved in one of the various branches of laboratory medicine, intending to write a document to serve as a reference measurement procedure.

In-Vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs - Darstellung von Referenzmeßverfahren

Diese Europäische Norm legt Anforderungen für die Darstellung eines Referenzmeßverfahrens fest. Anmerkung: Zweck dieser Festlegungen ist es zu ermöglichen, daß ein erfahrener Mitarbeiter eines Laboratoriums in der Lage ist; ein Meßverfahren, welches nach dieser Europäischen Norm beschrieben ist, mit einer Meßunsicherheit außuführen, die den festgelegten Bereich nicht überschreitet. Diese Europäische Norm gilt für Personen, Organisationen oder Institutionen, die in einem der verschiedenen Zweige der Laboratoriumsmedizin tätig sind und beabsichtigen, ein Dokument zu erarbeiten, das als Referenzmeßverfahren dienen soll.

Dispositifs médicaux de diagnostic in vitro - Mesure des grandeurs dans des échantillons d'origine biologique - Présentation des modes opératoires de mesure de référence

La présente norme européenne spécifie les exigences relatives à la rédaction d'un mode opératoire de mesure de référence.  NOTE: Elle a pour but de permettre à un laborantin expérimenté qui suit un mode opératoire écrit selon la présente norme européenne, d'espérer obtenir des résultats ayant un degré d'incertitude ne dépassant pas le domaine prescrit.  La présente norme européenne est applicable à toute personne, tout organisme ou toute institution, impliqué dans l'une des branches de la médecine de laboratoire, qui a l'intention de rédiger un document qui servira de mode opératoire de mesure de référence.

Diagnostični medicinski pripomočki in vitro – Merjenje količin v vzorcih biološkega izvora – Predstavitev referenčnih merilnih postopkov

General Information

Status
Withdrawn
Publication Date
17-Nov-1998
Withdrawal Date
29-Jul-2009
ICS
11.100 - Laboratory medicine
Technical Committee
CEN/TC 140 - In vitro diagnostic systems
Drafting Committee
CEN/TC 140/WG 4 - Reference systems
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
30-Jul-2009
Completion Date
30-Jul-2009
Directive
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
Ref Project
SIST EN 12286:2000 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures

Relations

Amended By
EN 12286:1998/A1:2000 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
Effective Date
22-Dec-2008

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SLOVENSKI STANDARD
SIST EN 12286:2000
01-januar-2000
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In vitro diagnostic medical devices - Measurement of quantities in samples of biological
origin - Presentation of reference measurement procedures
In-Vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs -
Darstellung von Referenzmeßverfahren
Dispositifs médicaux d
...

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This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).
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c)   RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM's intended use statement).
d)   IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.
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d)   properties reported as nominal scales and ordinal scales, where no magnitude is involved.
NOTE 2  Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.
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