PD ISO/TR 15499:2012 - Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

PD ISO/TR 15499:2012

Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

Status : Revised, Superseded, Withdrawn   Published : February 2013 Replaced By : PD ISO/TR 15499:2016

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Standard NumberPD ISO/TR 15499:2012
TitleBiological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
StatusRevised, Superseded, Withdrawn
Publication Date28 February 2013
Withdrawn Date31 January 2017
Normative References(Required to achieve compliance to this standard)ISO 10993-1:2009
Informative References(Provided for Information)ISO 10993-7, ISO 10993-9, ISO 10993-12, ISO 10993-13, ISO 10993-14, ISO 10993-15, ISO 10993-16, ISO 10993-17, ISO 10993-18, ISO 10993-19, ISO 13485:2003, ISO 14971:2007, ISO/IEC 17025
Replaced ByPD ISO/TR 15499:2016
International RelationshipsISO/TR 15499:2012
DescriptorsMedical equipment, Biological analysis and testing, Medical instruments, Medical technology, Biological hazards, Dental equipment, Dental materials, Implants (surgical), Clinical investigation instruments, Bioassay, Cytotoxicity tests, Contaminants, Compatibility
ICS11.100.20
Title in FrenchÉvaluation biologique des dispositifs médicaux. Directives relatives à la conduite d’une évaluation biologique au sein d’un procédé de management du risque
CommitteeCH/194
ISBN978 0 580 69433 2
PublisherBSI
FormatA4
DeliveryNo
Pages24
File Size1.186 MB
Price£182.00


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