BS EN ISO 10993-13:2010 - Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices

BS EN ISO 10993-13:2010

Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices

Status : Confirmed, Current   Published : October 2010
Conformity to regulation : Designated

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Standard NumberBS EN ISO 10993-13:2010
TitleBiological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices
StatusConfirmed, Current
Publication Date31 October 2010
Conformity to regulationDesignated
Confirm Date02 May 2019
Normative References(Required to achieve compliance to this standard)ISO 3696, ISO 10993-12, ISO 10993-1, ISO 10993-9, ISO 10993-17
Informative References(Provided for Information)90/385/EEC, 93/42/EEC, ISO 14971, ISO 13781:2017
ReplacesBS EN ISO 10993-13:2009
International RelationshipsEN ISO 10993-13:2010,ISO 10993-13:2010
Draft Superseded By08/30156451 DC
DescriptorsDecomposition reactions, Biological analysis and testing, Degradation, Identification methods, Testing conditions, Biology, Polymers, Quantitative analysis, Accelerated testing, Medical equipment, Deterioration, Chemical analysis and testing
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux. Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères
Title in GermanBiologische Beurteilung von Medizinprodukten. Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren
CommitteeCH/194
ISBN978 0 580 57719 2
PublisherBSI
FormatA4
DeliveryYes
Pages28
File Size1.33 MB
Price£186.00


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