19/30378312 DC - BS ISO 21151. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples
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19/30378312 DC

BS ISO 21151. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples

Status : Current, Draft for public comment   Published : March 2019

Format
PDF

Format
HARDCOPY






Standard Number19/30378312 DC
TitleBS ISO 21151. In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples
StatusCurrent, Draft for public comment
Publication Date20 March 2019
Normative References(Required to achieve compliance to this standard)ISO 17511
Informative References(Provided for Information)ISO 17511:xxxx, ISO 18113-2
International RelationshipsISO/DIS 21151
Draft Expiry Date06 May 2019
DescriptorsTest methods, Harmonization, Biological tests, Measurement, Medical equipment
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro — Mesurage de quantités dans les échantillons d’origine biologique — Exigences relatives aux protocoles d’harmonisation internationaux destinés à établir la traçabilité métrologique des valeurs affectées aux étalons de produits (utilisateur final) et aux échantillons de patients
CommitteeCH/212
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size1.152 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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