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

PD ISO/TR 15499:2016 - TC

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

Status : Current   Published : February 2020

Format
PDF






Standard NumberPD ISO/TR 15499:2016 - TC
TitleTracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
StatusCurrent
Publication Date26 February 2020
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO 10993-14, ISO 10993-16, ISO 10993-9, ISO/TS 10993-19, ISO/IEC 17025, ISO 10993-15, ISO 10993-13, ISO 10993-11, ISO 14971:2007, ISO 10993-1:2009, ISO 13485:2016, ISO 10993-7, ISO 10993-17, ISO 10993-12, ISO 10993-18:2005
DescriptorsImplants (surgical), Medical equipment, Dental equipment, Biological analysis and testing, Biological hazards, Compatibility, Cytotoxicity tests, Bioassay, Contaminants, Dental materials, Medical technology, Medical instruments, Clinical investigation instruments
ICS11.100.20
CommitteeCH/194
ISBN978 0 539 09388 9
PublisherBSI
FormatA4
DeliveryYes
Pages49
File Size3.402 MB
Price£236.60


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