BS EN ISO 10993-15-2009 Biological evaluation of medical devices - Part 15 Identification and quantification of degradation nproducts from metals and alloys (ISO 10993-15 2000)《医疗器.pdf

1、 , b) ratio of the exposed surface area of the sample to the volume of the electrolyte;c) composition and pH (with an uncertainty of Gb1 0,1) of the electrolyte and a description of the natural or referenceelectrode for the electrochemical test;d) composition and initial and final pH of the electrol

2、yte for the immersion test;e) temperature of the electrolyte;f) current density vs. potential curve(s), optionally the log (current density) vs. potential curve for comparison;g) open-circuit potential;h) breakdown potential Epand the current density at the breakdown potential;i) sweep rate;j) curre

3、nt density vs. time curve(s) and total test time;k) brief comments on the curves (e.g. hysteresis, peaks);l) description of any significant changes of the sample surface and/or of the electrolyte;m) results of analysis of degradation elements in the electrolyte, including degradation rate, reported

4、inmicrograms per square centimetre per hour (G6dg/cm2/h) for the electrostatic test or per seven days(G6dg/cm2/7 days) for the immersion test;n) method of chemical analysis of electrolyte;o) type of reference electrode all potentials should be referenced to the normal hydrogen electrode (NHE);p) nam

5、e of investigator;q) date(s) of investigation;r) signature of the investigator.BS EN ISO 10993-15:2009ISO 10993-15:2000(E) ISO 2000 All rights reserved 9Annex A(informative)Schematic diagram of the electrochemical measuring circuitKey1 Potentiostat2 Potential measurement3 Current measurement4 Workin

6、g electrode5 Counter-electrode6 Reference electrodeFigure A.1 Schematic diagram of the electrochemical measuring circuitBS EN ISO 10993-15:2009ISO 10993-15:2000(E)10 ISO 2000 All rights reservedAnnex B(informative)Schematic drawing of an electrolytic cellKey1 Constant-temperature cell 9 Electrolytic

7、 bridge2 Electrolyte 10 Reference electrode3 Water outlet 11 Saturated KCL solution4 Gas inlet 12 Luggin capillary5 Thermometer 13 Constant-temperature water inlet6 Counter-electrode 14 Magnetic stirring bar7 Working electrode 15 Magnetic stirrer8 Gas outletFigure B.1 Schematic drawing of an electro

8、lytic cellBS EN ISO 10993-15:2009ISO 10993-15:2000(E) ISO 2000 All rights reserved 11Annex C(informative)Examples of alternative electrolytes for the electrochemical testsC.1 GeneralAll chemicals shall be of analytical grade and dissolved in high purity water, grade 2 in accordance with ISO 3696.Car

9、e shall be taken to avoid precipitation when preparing these solutions.C.2 Artificial saliva (see 2)Na2HPO40,260 g/lNaCl 0,700 g/lKSCN 0,330 g/lKH2PO4. 0,200 g/lNaHCO31,500 g/lKCl 1,200 g/lC.3 Artificial plasma (see 2)NaCl 6,800 g/lCaCl2. 0,200 g/lKCl 0,400 g/lMgSO40,100 g/lNaHCO32,200 g/lNa2HPO40,1

10、26 g/lNaH2PO40,026 g/lBS EN ISO 10993-15:2009ISO 10993-15:2000(E)12 ISO 2000 All rights reservedBibliography1 ASTM G 5-94, Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic PolarizationMeasurements.2 AFNOR NF 91-141G 5-94, Biodegradability of dental metal alloys Standardizat

11、ion of electrochemicaltest.3 ISO 10993-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits forleachable substances using health-based risk assessment.4 ISO 10271, Dental metallic materials Corrosion test methods.C78,00D8E(.,0F “ ?“ ()*+,-.,/0014,.23()*+,-.,/0014,8“(“ “ 9 “ “ 7 (; “;762 “ (; “ ! & & 3 “ ! &A 5 ? 80/ 3 “ & “ “ “ “ B & & B “ “ & “ “ & “ & & “ “ “ “ A “ ! 6 ()*+,-.,/0014,4,“( 9 “