Norm

ISO/TS 10993-19:2006 en

Biologische evaluatie van medische hulpmiddelen - Deel 19: Fysisch-chemische, morfologische en topografische eigenschappen van materialen

73,12

Over deze norm

Status Definitief
Aantal pagina's 15
Commissie Biocompatibiliteit en biologisch onderzoek
Gepubliceerd op 01-06-2006
Taal Engels
This Technical Specification provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. Chemical characterization of materials is covered by ISO 10993-18.

Details

ICS-code 11.100.20
Nederlandse titel Biologische evaluatie van medische hulpmiddelen - Deel 19: Fysisch-chemische, morfologische en topografische eigenschappen van materialen
Engelse titel Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials

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