BS EN ISO 10993-1:October 2009 - Biological evaluation of medical devices. Evaluation and testing within a risk management process

BS EN ISO 10993-1:October 2009

Biological evaluation of medical devices. Evaluation and testing within a risk management process

Status : Superseded, Withdrawn   Published : June 2010 Replaced By : BS EN ISO 10993-1:2020

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Standard NumberBS EN ISO 10993-1:October 2009
TitleBiological evaluation of medical devices. Evaluation and testing within a risk management process
StatusSuperseded, Withdrawn
Publication Date30 June 2010
Withdrawn Date16 December 2020
Normative References(Required to achieve compliance to this standard)ISO 10993-6, ISO/TS 10993-19, ISO/TS 10993-20, ISO 10993-10, ISO 10993-3, ISO 10993-9, ISO 10993-14, ISO 10993-17, ISO 14971, ISO 10993-16, ISO 10993-11, ISO 10993-2, ISO 10993-13, ISO 10993-12, ISO 10993-15, ISO 10993-18:2005, ISO 10993-7, ISO 10993-5, ISO 10993-4:2017
Informative References(Provided for Information)ISO 7405, ISO 13485, ISO 9000, ISO 9001, ISO/IEC 17025, ISO 9004, 93/42/EEC, 90/385/EEC
Replaced ByBS EN ISO 10993-1:2020
ReplacesBS EN ISO 10993-1:June 2009
Amended ByCorrigendum, January 2017; Corrigendum, November 2010
DescriptorsCytotoxicity tests, Bioassay, Clinical investigation instruments, Dental materials, Medical equipment, Compatibility, Implants (surgical), Biological hazards, Biological analysis and testing, Medical instruments, Dental equipment, Contaminants, Medical technology
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux. Évaluation et essais au sein d'un processus de gestion du risque
Title in GermanBiologische Beurteilung von Medizinprodukten. Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems
CommitteeCH/194
ISBN978 0 580 97500 4
PublisherBSI
FormatA4
DeliveryYes
Pages32
File Size1.821 MB
NotesImplements EN ISO 10993-1:2009, October edition.
Price£218.00


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