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
- 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
Relations
- Effective Date
- 28-Jan-2026
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 12286:1998 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 - Presentation of reference measurement procedures". This standard covers: 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.
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.
EN 12286:1998 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 12286:1998 has the following relationships with other standards: It is inter standard links to EN 14136:2004, EN 12286:1998/A1:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12286:1998 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 12286:1998 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 - 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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