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Reporting of data obtained
informative Principles forjudging toxicological equivalency
abbreviated terms allowable limits analytical methods and/or Annex applicable Biological evaluation ceramics characterization of materials characterization procedure chemical characterization data chemical characterization required chemicals present chromatography Clause clinically established material compositional and formulation comprehensive or exclusive constituents degradation products DMTA duration estimated clinical exposure evaluation of medical Examples of parameters exhaustive extraction extraction conditions finished device Flowchart FTIR glass transition temperature identification and quantification identified Infrared spectroscopy Judging equivalence Mass spectroscopy master file Material equivalence medical device manufacturer member bodies Metals and alloys methodologies for analysis Molecular mass mould release agents Natural macromolecules Nuclear magnetic resonance obtained Parameters and test Pendant group phase equilibrium polymeric chemicals polymers Qualitative information quantification of degradation quantitative data Quantitative not comprehensive relevant risk assessment simulated extraction Sol-gel specify the material Static light scattering Step supplier technical committees test methodologies toxicological equivalence toxicological risk assessor USAN X-ray diffraction X-ray fluorescence