ISO 14607:2018 pdf free

ISO 14607:2018 pdf free.Non-active surgical implants一Mammary implants一Particular requirements
The quantitative analysis of D4 and D5 in a cured or uncured silicone gel is carried out using a gas chromatograph (GC) equipped with a flame ionizing detector (FID) and a capillary column or using a gas chromatograph with a mass spectrometer (GC-MS). When using a gas chromatograph without a mass spectrometer, the identification of D4 and D5 in the silicone gel is determined by comparing the retention times of the eluted molecules found in the silicone gel to the known retention times of D4 and D5 as determined through the analysis of D4 and D5 calibration standards. When using a gas chromatograph with a mass spectrometer, the identification of D4 and D5 in the silicone gel is determined by comparing the mass spectra of the test specimen to a mass spectra reference library.The concentration of D4 and D5 in the silicone gel is determined using calibration curves developed through the analysis of D4 and D5 calibration standards at known concentrations. Calibrations may be performed using either an internal or an external calibration standard. Results shall be reported to the nearest part per million (ppm) or milligram per kilogram (mg/ kg) on a weight per weight (w/w) basis.
The silicone gel can be analysed in its cured or uncured state. The silicone gel shall be mixed per the material manufacturer’s recommended mixing procedure. If the silicone gel is analysed in its cured state, the silicone gel shall be cured per the material manufacturer’s recommended cure schedule.The silicone gel can be analysed neat or diluted using a volatile organic solvent. The test specimen preparation method shall be calibrated at time of use.
Turn on the gas chromatograph per the material manufacturer’s recommended procedure. Verify that the gas chromatograph is functioning properly and is capable of performing the analysis. The gas chromatography method shall be validated by determining the selectivity, accuracy, range, robustness;precision and limit of quantitation of the gas chromatography method (see A.10). A calibration verification and a method blank shall be performed prior to the test specimen analysis.ISO 14607 pdf free download.