19/30378309 DC - BS EN ISO 17511. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

19/30378309 DC

BS EN ISO 17511. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

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

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Standard Number19/30378309 DC
TitleBS EN ISO 17511. In vitro diagnostic medical devices. Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
StatusCurrent, Draft for public comment
Publication Date20 March 2019
Normative References(Required to achieve compliance to this standard)ISO/IEC Guide 99:2007
Informative References(Provided for Information)ISO/CD 21151, ISO 15194, ISO 9000, ISO 18113-1, ISO 17025, ISO/IEC Guide 98-3:2008, ISO 15195, ISO 15193, ISO 18113-2, ISO Guide 31:2015, ISO Guide 35:2017, ISO/TR 16476:2016, ISO 5725-1:1994/COR 1:1998, ISO 20391-1:2018, IEC 60050-300:2001, ISO 15189:2012, ISO 18153:2003, ISO 17034:2016
International RelationshipsISO/DIS 17511
Draft Expiry Date07 May 2019
DescriptorsDocumentation, Technical requirements, Control samples, Clinical investigation instruments, Measurement, Medical instruments
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro — Mesurage des grandeurs dans des échantillons d'origine biologique — Traçabilité métrologique des valeurs attribuées aux agents d'étalonnage et aux matériaux de contrôle
CommitteeCH/212
PublisherBSI
FormatA4
DeliveryYes
Pages62
File Size3.672 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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