PD ISO/TR 15499:2016 - Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process

PD ISO/TR 15499:2016

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

Status : Current   Published : January 2017

Format
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Standard NumberPD ISO/TR 15499:2016
TitleBiological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
StatusCurrent
Publication Date31 January 2017
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO 10993-12, ISO 10993-14, ISO 10993-16, ISO 10993-13, ISO 10993-11, ISO 10993-17, ISO 10993-9, ISO 14971:2007, ISO/TS 10993-19, ISO 10993-15, ISO 10993-1:2009, ISO/IEC 17025, ISO 10993-18:2005, ISO 10993-7, ISO 13485:2016
ReplacesPD ISO/TR 15499:2012
International RelationshipsISO/TR 15499:2016
DescriptorsBiological analysis and testing, Compatibility, Contaminants, Medical equipment, Medical instruments, Implants (surgical), Cytotoxicity tests, Dental materials, Medical technology, Biological hazards, Bioassay, Dental equipment, Clinical investigation instruments
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 95983 7
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size746 KB
Price£182.00


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