BS EN ISO 10993-1:2020 - TC - Tracked Changes. Biological evaluation of medical devices. Evaluation and testing within a risk management process

BS EN ISO 10993-1:2020 - TC

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

Status : Current   Published : December 2020

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Standard NumberBS EN ISO 10993-1:2020 - TC
TitleTracked Changes. Biological evaluation of medical devices. Evaluation and testing within a risk management process
StatusCurrent
Publication Date21 December 2020
Normative References(Required to achieve compliance to this standard)ISO 14971:2007, ISO 10993-2:2006, ISO 10993-11:2017, ISO 10993-3, ISO 10993-10, ISO 10993-16, ISO 10993-6, ISO 10993-7, ISO 10993-17, ISO 10993-5, ISO 10993-13, ISO 10993-9, ISO 10993-15, ISO 10993-14, ISO 10993-12, ISO 10993-4, TS 10993-20, ISO 10993-18
Informative References(Provided for Information)TR 10993-22, ISO 18562 (all parts), TR 10993-33, ISO 7405, ISO 9000, ISO 9001, TR 10993-19, IEC 17025, ISO 9004, ISO 13485:2016
DescriptorsContaminants, Medical instruments, Biological analysis and testing, Dental equipment, Implants (surgical), Biological hazards, Dental materials, Bioassay, Medical technology, Medical equipment, Cytotoxicity tests, Compatibility, Clinical investigation instruments
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 0 539 16453 4
PublisherBSI
FormatA4
DeliveryYes
Pages110
File Size2.888 MB
Price£346.00


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