BS EN ISO 23640:2015 In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

BS EN ISO 23640:2015

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

Status : Current, Under review   Published : June 2015
Conformity to regulation : Designated

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BS EN ISO 23640:2015

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents




Standard NumberBS EN ISO 23640:2015
TitleIn vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
StatusCurrent, Under review
Publication Date30 June 2015
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 14971
Informative References(Provided for Information)98/79/EC, EN 13640, ISO 18113-1:2009, CLSI EP25-A
ReplacesBS EN ISO 23640:2013
International RelationshipsEN ISO 23640:2015,ISO 23640:2011
DescriptorsMedical equipment, Diagnostic reagents, Stability testing, Verification, Life (durability), Storage, Stability, Chemical reagents, Diagnosis (medical)
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro. Évaluation de la stabilité des réactifs de diagnostic in vitro
Title in GermanIn-vitro-Diagnostika. Haltbarkeitsprüfung von Reagenzien für in-vitro-diagnostische Untersuchungen
CommitteeCH/212
ISBN978 0 580 90814 9
PublisherBSI
FormatA4
DeliveryYes
Pages16
File Size992 KB
Price£134.00


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