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ISO 15309:2013 pdf free

ISO 15309:2013 pdf free.Implants for surgery一Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
The test specimens of PEEK polymer can be in the form of powder, granules or pellets, or it may be cut from sample pieces of moulded or extruded polymer. When cutting specimens care shall be taken to avoid heating or polymer re-orientation that could affect the properties. Ideally a sharp scalpel, snips or a microtone should be used.
Testing shall be undertaken under ambient laboratory conditions. The DSC shall be switched on at least one hour before testing to allow for equilibration of the electronics and temperature.
Determine the transition temperatures for the two standard materials and measure the extrapolated onset temperature in accordance with ISO 11357-1. Compare the nominal values to the recorded values.
The temperature calibration repeatability shall be better than 2 %.
Place empty crucibles of the same nominal mass at the specimen and reference positions in the crucible holder. Adjust the experimental conditions to those which will be used for the actual measurement run. The recorded DSC curve (i.e. the instrument baseline) should be close to a straight line over the required temperature range. If significant baseline curvature is observed, check the crucible holder for contamination.
NOTE With computer-controlled instruments, any remaining curvature can be corrected for by subtracting the instrument baseline from the DSC curve.
When a reasonably straight line cannot be obtained, record the DSC curve after confirming its repeatability.
At least two specimens shall be prepared for each batch or sample under investigation using the following procedure.
一Weigh the sample pan and lid to the nearest 0,1 mg.
一Place the PEEK sample into the pan. The sample weight shall be adjusted so that it is between 5 mg and 15 mg. Record the specimen weight to the nearest 0,1 mg.
一Re-weigh the sealed sample pan and record the weigh to the nearest 0,1 mg.
一Seal the pan using a lid per the manufacturer’s recommended procedure.
一Weigh and record the reference pan to the nearest 0,1 mg. Seal the pan using a lid per the manufacturer’s recommended procedure.
一Re-weigh the sealed reference pan and record the weigh to the nearest 0,1 mg.ISO 15309 pdf download.

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