EN 12287:1999
(Main)In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials
This European Standard specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This European Standard also provides instructions on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate. This European Standard is not applicable to the production of the reference materials.
In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs - Beschreibung von Referenzmaterialien
Diese Europäische Norm legt Anforderungen an und Formate für die Beschreibung von Referenzmaterialien fest. Sie gilt für Referenzmaterialien höherer metrologischer Ordnung wie den Primärmeßnormalen und Sekundärmeßnormalen, die entweder als Kalibriermaterialien oder als Kontrollmaterialien dienen. Diese Norm gilt nicht für Referenzmaterialien, die Bestandteile eines Meßsystems zur In-vitro-Diagnose sind. Diese Europäische Norm enthält Festlegungen darüber, wie die Ausgangsdaten für die Ermittlung der Werte zu sammeln sind und wie der zugeordnete Wert darzustellen ist.
Dispositifs médicaux de diagnostic in vitro - Mesure des grandeurs dans les échantillons d'origine biologique - Description des matériaux de référence
La présente norme européenne spécifie les prescriptions et les présentations requises pour la description des matériaux de référence. Elle s'applique aux matériaux de référence de niveau métrologique supérieur tels que les étalons de mesure primaires, les étalons de mesure secondaires qui fonctionnent soit comme des calibrateurs, soit comme des matériaux de contrôle pour les modes opératoires de mesure de référence. La présente norme européenne ne s'applique pas aux matériaux de référence qui font partie d'un système de diagnostic in vitro.
Diagnostični medicinski pripomočki in vitro - Merjenje količin v vzorcih biološkega izvora - Opis referenčnih materialov
General Information
- Status
- Withdrawn
- Publication Date
- 22-Jun-1999
- Withdrawal Date
- 10-Aug-2009
- 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
- 11-Aug-2009
- Completion Date
- 11-Aug-2009
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Frequently Asked Questions
EN 12287:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Description of reference materials". This standard covers: This European Standard specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This European Standard also provides instructions on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate. This European Standard is not applicable to the production of the reference materials.
This European Standard specifies requirements and formats for the description of reference materials. It is applicable to reference materials of higher metrological order, classifiable as primary measurement standards and secondary measurement standards that function either as calibrators or control materials for reference measurement procedures. This standard does not apply to reference materials that are parts of an in vitro diagnostic measuring system. This European Standard also provides instructions on how to collect basic data for value determination and how to present the assigned value. The standard also specifies the format for a certificate. This European Standard is not applicable to the production of the reference materials.
EN 12287:1999 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12287:1999 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 12287:1999 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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In vitro diagnostic medical devices - Measurement of quantities in samples of biological
origin - Description of reference materials
In-vitro-Diagnostika - Messung von Größen in Proben biologischen Ursprungs -
Beschreibung von Referenzmaterialien
Dispositifs médicaux de diag
...
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