Over deze norm
|Commissie||In vitro diagnostica|
This European Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices. External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of this European Standard. This Part of EN 13244 gives guidance for the assessment of conformity to be included in the manufacturer's quality plan as part of his quality system. This Technical Specification includes: a) requirements for materials, components, joints and assemblies given in Parts 1 to 5 of EN 13244; b) requirements for the manufacturer's quality system; c) definitions and procedures to be applied if third party certification is involved. In conjunction with one or more Parts of EN 13244 (see Foreword) it is applicable to polyethylene (PE) piping systems intended to be used for buried and above-ground pressure systems for water for general purposes, drainage and sewerage.
|Nederlandse titel||In vitro diagnostische medische apparatuur - Meting van de quantiteiten in biologische monsters - Metrologische traceerbaarheid van waarden toegewezen aan kalibratiemiddelen en controlematerialen|
|Engelse titel||In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials|