BS EN ISO 10993-16:2017 - Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables

BS EN ISO 10993-16:2017

Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables

Status : Current   Published : January 2018

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Standard NumberBS EN ISO 10993-16:2017
TitleBiological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables
StatusCurrent
Publication Date09 January 2018
Normative References(Required to achieve compliance to this standard)ISO 10993-1:2009
Informative References(Provided for Information)ISO 14971:2007, ISO/TR 10993-22:2017, ISO 10993-2:2006, ISO 10993-18:2005, ISO 10993-12:2012, ISO 10993-17:2002
ReplacesBS EN ISO 10993-16:2010
International RelationshipsEN ISO 10993-16:2017,ISO 10993-16:2017
Amended ByCorrigendum, February 2018
DescriptorsDecomposition reactions, Leaching, Toxicity, Toxicology, Metabolism, Absorption, Design, Biological analysis and testing, Medical equipment, Degradation
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux Conception des études toxicocinétiques des produits de dégradation et des substances relargables
Title in GermanBiologische Beurteilung von Medizinprodukten Entwurf und Auslegung toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und herauslösbaren Substanzen
CommitteeCH/194
ISBN978 0 580 92910 6
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size624 KB
Price£182.00


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